ABSTRACT
BACKGROUND: Acne vulgaris commonly affects adults, adolescents, and preadolescents aged 9 years or older. OBJECTIVE: The objective of this study was to provide evidence-based recommendations for the management of acne. METHODS: A work group conducted a systematic review and applied the Grading of Recommendations, Assessment, Development, and Evaluation approach for assessing the certainty of evidence and formulating and grading recommendations. RESULTS: This guideline presents 18 evidence-based recommendations and 5 good practice statements. Strong recommendations are made for benzoyl peroxide, topical retinoids, topical antibiotics, and oral doxycycline. Oral isotretinoin is strongly recommended for acne that is severe, causing psychosocial burden or scarring, or failing standard oral or topical therapy. Conditional recommendations are made for topical clascoterone, salicylic acid, and azelaic acid, as well as for oral minocycline, sarecycline, combined oral contraceptive pills, and spironolactone. Combining topical therapies with multiple mechanisms of action, limiting systemic antibiotic use, combining systemic antibiotics with topical therapies, and adding intralesional corticosteroid injections for larger acne lesions are recommended as good practice statements. LIMITATIONS: Analysis is based on the best available evidence at the time of the systematic review. CONCLUSIONS: These guidelines provide evidence-based recommendations for the management of acne vulgaris.
Subject(s)
Acne Vulgaris , Anti-Bacterial Agents , Benzoyl Peroxide , Dermatologic Agents , Dicarboxylic Acids , Doxycycline , Isotretinoin , Salicylic Acid , Spironolactone , Humans , Acne Vulgaris/drug therapy , Isotretinoin/administration & dosage , Isotretinoin/therapeutic use , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Dermatologic Agents/administration & dosage , Dermatologic Agents/therapeutic use , Benzoyl Peroxide/administration & dosage , Benzoyl Peroxide/therapeutic use , Dicarboxylic Acids/administration & dosage , Dicarboxylic Acids/therapeutic use , Spironolactone/administration & dosage , Spironolactone/therapeutic use , Doxycycline/administration & dosage , Doxycycline/therapeutic use , Salicylic Acid/administration & dosage , Salicylic Acid/therapeutic use , Evidence-Based Medicine/standards , Administration, Oral , Retinoids/administration & dosage , Retinoids/therapeutic use , Tetracyclines/administration & dosage , Tetracyclines/therapeutic use , Adolescent , Minocycline/administration & dosage , Minocycline/therapeutic use , Child , Administration, Cutaneous , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Combined/therapeutic use , Drug Therapy, Combination , Female , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/therapeutic use , Injections, Intralesional , Adult , Cortodoxone/analogs & derivatives , PropionatesABSTRACT
Objective: The condition of the skin can vary due to weather fluctuations. Therefore, this post-hoc analysis evaluated efficacy and safety of tazarotene 0.045% lotion in warmer versus colder months. Methods: In two Phase III, double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene or vehicle lotion. The pooled population (N=1,614) was stratified by randomization date (warmer=May to September; colder=October to April). Evaluations included inflammatory/noninflammatory lesion counts, treatment success, adverse events, and safety/tolerability. Results: Tazarotene 0.045% lotion was similarly efficacious over colder and warmer months. Compared with vehicle, tazarotene demonstrated significantly greater least-squares mean absolute reductions from baseline to Week 12 in inflammatory (colder/warmer tazarotene vs. vehicle: -16.6/-15.8 vs. -13.2/-12.9) and noninflammatory lesions (-23.2/-22.6 vs. -17.5/-15.1); treatment success rates were also significantly higher (30.1/30.8% vs. 18.2/17.6%) (P<0.001, all). No strong seasonal trends in safety were observed, though tazarotene led to slightly more discontinuations (3.4% vs. 1.9%) and related adverse events (12.0% vs. 10.3%) in colder versus warmer months. Transient increases in scaling, erythema, and itching at Weeks 2 to 8 of tazarotene treatment were slightly higher in colder versus warmer months but returned to baseline/improved by Week 12. Limitations: Geographical variation across study sites can lead to varying temperatures and humidity within the same months. Conclusion: Tazarotene 0.045% lotion was efficacious and well tolerated for acne treatment, regardless of season. Year-round tolerability of tazarotene 0.045% lotion may be due to its lower tazarotene concentration and polymeric emulsion technology, which simultaneously delivers moisturizers/humectants/emollients to skin.
ABSTRACT
BACKGROUND: Excessive sebum production is a factor in acne development. Tazarotene 0.045% lotion has demonstrated reductions in acne lesions and acne-induced sequelae. OBJECTIVE: Evaluate efficacy, changes in skin oiliness, and safety with tazarotene 0.045% lotion in participants with moderate-to-severe acne and oily skin. METHODS: In two phase 3, double-blind, 12-week studies (NCT03168321; NCT03168334), participants aged ≥ 9 years with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene 0.045% lotion or vehicle lotion (N = 1614). This pooled, post hoc analysis included only participants self-categorized with oily skin at baseline on the Acne-Specific Quality of Life questionnaire item 19 (scores: 0 [extremely oily] to 6 [not at all oily]). Inflammatory/noninflammatory lesion counts, treatment success, skin oiliness, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were evaluated. RESULTS: In all participants with oily skin (n = 793), tazarotene provided greater reductions in inflammatory/noninflammatory lesions (p < 0.001, both) and greater treatment success rates versus vehicle (p < 0.01) at week 12. Over two-thirds of polymeric lotion-treated participants had subjective skin oiliness reductions by week 12, with around a third reporting 'low/not' oily skin. Tazarotene TEAE rates were similar to the overall population. CONCLUSIONS: Once-daily treatment with tazarotene 0.045% polymeric emulsion lotion may help improve patient-perceived skin oiliness in those with moderate-to-severe acne.
Subject(s)
Acne Vulgaris , Dermatologic Agents , Humans , Tretinoin/therapeutic use , Keratolytic Agents/therapeutic use , Quality of Life , Severity of Illness Index , Skin Cream/therapeutic use , Acne Vulgaris/drug therapy , Acne Vulgaris/pathology , Administration, Cutaneous , Treatment Outcome , Double-Blind Method , Emulsions , Dermatologic Agents/adverse effectsABSTRACT
BACKGROUND: While topical retinoids are a mainstay of acne treatment, acne can manifest differently in various skin types. The objective of these post hoc analyses from two pooled phase 3 studies was to examine efficacy and safety of tazarotene 0.045% and quality of life improvements in self-identified Caucasian adults with moderate-to-severe acne. METHODS: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion (N=1,614); a subset of adults (≥18 years) who self-reported Caucasian (White) race (n=645) were examined. Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment (endpoint) success (≥2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear]). Quality of life, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability were also assessed. RESULTS: At week 12, tazarotene lotion significantly reduced lesion counts by ~60% (least-squares mean percent changes from baseline, tazarotene vs vehicle: inflammatory, -61.2% vs -51.1%; noninflammatory, -59.7% vs -49.3%; P<0.001, both). Significantly more participants achieved treatment success with tazarotene lotion versus vehicle (P<0.001). Numerical improvements in quality-of-life domains were observed from baseline to week 12. Most TEAEs were unrelated to treatment, and rates of moderate-to-severe erythema decreased from baseline to week 12 with tazarotene treatment. CONCLUSIONS: Tazarotene 0.045% lotion was efficacious and well tolerated over 12 weeks and led to quality-of-life improvements in Caucasian adults with moderate-to-severe acne. These results, along with those from patients with skin of color, demonstrate that once daily tazarotene 0.045% lotion is an effective and well-tolerated treatment option regardless of race or skin color.J Drugs Dermatol. 2022;21(10):1061-1069. doi:10.36849/JDD.6834.
Subject(s)
Acne Vulgaris , Dermatologic Agents , Nicotinic Acids , Acne Vulgaris/diagnosis , Acne Vulgaris/drug therapy , Acne Vulgaris/etiology , Administration, Cutaneous , Adult , Dermatologic Agents/adverse effects , Double-Blind Method , Emollients/therapeutic use , Emulsions/therapeutic use , Humans , Quality of Life , Retinoids/therapeutic use , Severity of Illness Index , Skin Cream/adverse effects , Treatment OutcomeABSTRACT
INTRODUCTION: Half of the individuals with facial acne develop truncal acne, but the impact of combined facial and truncal acne (CA) on patients' quality of life is poorly researched. METHODS: A 60-min interview of 30 participants with CA was conducted that formed the basis for a cross-sectional survey of 694 adolescents and adults with CA. RESULTS: The main themes identified from the qualitative interviews among CA subjects included acceptability to self and others, social functioning and emotional wellbeing. Feelings of embarrassment, self-consciousness and low confidence were experienced often or all the time by over 50% of participants, and were more frequent in those who perceived their acne to be out of control (P = 0.003). Half of patients reported feeling stigmatised because of their CA, and 65.4% believed that others associated their truncal acne with unhealthy or unhygienic habits. Perceived stigma was associated with more feelings of embarrassment (P = 0.005), self-consciousness (P = 0.034) and low self-confidence (P = 0.017). Overall, 64% participants reported that CA interfered with daily life, 46.4% often or always avoided social interaction, 48.6% were often concerned about talking to unfamiliar people and 47.4% were uncomfortable showing affection. Further, 32% and 24.4% participants ≥ 16 years old avoided dating or having romantic/intimate relationships because of their facial and truncal acne, respectively. Social and leisure activities were more frequently negatively impacted among those with perceived uncontrolled CA than among those with controlled CA. Avoiding undressing in front of spouse/partner/friends/relatives was more commonly reported by participants with perceived uncontrolled truncal acne than by those with controlled truncal acne (90.5% versus 80.6%, P = 0.031). CONCLUSION: CA is associated with considerable psychological morbidity, with several exacerbating (e.g. perceived stigma) and attenuating factors (e.g. acne being perceived as being under control) that should be accounted for in CA management.
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BACKGROUND: Acne prevalence may be higher in overweight/obese individuals, potentially due to hormonal, inflammatory, and/or dietary factors. However, the effects of body mass index (BMI) on topical acne treatments are largely unknown. METHODS: Post hoc analyses of changes in inflammatory/noninflammatory lesions and treatment success were conducted using phase 3 data: clindamycin phosphate/benzoyl peroxide (CP/BPO) 1.2%/3.75% gel (NCT01701024); tretinoin 0.05% lotion (NCT02965456 and NCT02932306; pooled); and tazarotene 0.045% lotion (NCT03168321 and NCT03168334; pooled). Data were analyzed by BMI subgroups: <25kg/m2 (underweight-to-normal), 25-<30kg/m2 (overweight), and ≥30kg/m2 (obese). RESULTS: Among participants analyzed (CP/BPO = 495; tretinoin = 1,636; tazarotene = 1,612), â¼20-25% were overweight and 15-20% were obese. At week 12, mean percent changes from baseline in inflammatory lesions were: CP/BPO (overweight: -63.2%, obese: -56.0%); tretinoin (-57.6%, -53.1%); tazarotene (-59.9%, -56.8%). Mean changes in noninflammatory lesions were: CP/BPO (-54.2%, -50.8%); tretinoin (-51.6%, -44.9%); tazarotene (-56.7%, -54.6%). Treatment success rates with active treatment ranged from 16.2% to 33.5% across BMI groups. CONCLUSIONS: CP/BPO 1.2%/3.75% gel, tretinoin 0.05% lotion, and tazarotene 0.045% lotion were all effective in reducing acne lesions by ≥45% in overweight/obese patients with moderate-to-severe acne, comparable to the underweight-to-normal group. Efficacy of these topical acne treatments is not greatly impacted by BMI and may be affected more by the formulation.
Subject(s)
Acne Vulgaris , Dermatologic Agents , Humans , Body Mass Index , Overweight/complications , Overweight/drug therapy , Thinness/drug therapy , Severity of Illness Index , Double-Blind Method , Benzoyl Peroxide/therapeutic use , Acne Vulgaris/drug therapy , Acne Vulgaris/pathology , Clindamycin , Tretinoin , Treatment Outcome , Emulsions , Obesity , Gels , Dermatologic Agents/therapeutic useABSTRACT
BACKGROUND: Females aged ≥25 years may have acne with different etiology, presentation, burden, and treatment response than females 18–24 years. This post hoc analysis investigated efficacy and safety of tazarotene 0.045% lotion in females ≥18 years or ≥25 years of age. METHODS: In two phase 3 double-blind studies, participants 9 years of age and older with moderate-to-severe acne were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Pooled data were analyzed for females aged ≥18 years (n=744) or ≥25 years (n=335). Assessments included inflammatory/noninflammatory lesion counts, treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of 0 [clear] or 1 [almost clear]), Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability. RESULTS: At week 12, tazarotene-treated females in both age groups had greater reductions from baseline versus vehicle in inflammatory (≥18 years: 60.6% vs 53.7% [P<0.01]; ≥25 years: 60.9% vs 57.3% [P>0.05]) and noninflammatory lesions (59.0% vs 48.4% and 61.1% vs 48.8%; P<0.01, both). Rates of treatment success were greater with tazarotene versus vehicle; this difference was significant for females ≥18 years. Acne-QoL improvements were similar across age groups and generally greater with tazarotene than vehicle. TEAEs were mostly mild to moderate in severity. No age-related trends for safety or tolerability were observed. CONCLUSIONS: Tazarotene 0.045% lotion demonstrated comparable efficacy, improvement in quality of life, and safety in adult females aged ≥18 or ≥25 years with moderate-to-severe acne. This cosmetically elegant lotion is a well-studied and important treatment option for all patients, particularly adult females. J Drugs Dermatol. 2022;21(5):587-595. doi:10.36849/JDD.6876.
Subject(s)
Acne Vulgaris , Dermatologic Agents , Nicotinic Acids , Acne Vulgaris/diagnosis , Acne Vulgaris/drug therapy , Acne Vulgaris/etiology , Administration, Cutaneous , Adolescent , Adult , Child , Dermatologic Agents/adverse effects , Double-Blind Method , Emollients/therapeutic use , Emulsions/therapeutic use , Excipients , Female , Humans , Nicotinic Acids/adverse effects , Quality of Life , Severity of Illness Index , Skin Cream/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Most people with acne are at risk of developing acne scars, but the impact of these scars on patients' quality of life is poorly researched. OBJECTIVE: To assess the perspective of patients with acne scars and the impact of these scars on their emotional well-being and social functioning. METHODS: A 60-minute interview of 30 adults with acne scars informed and contextualized the development of a cross-sectional survey of 723 adults with atrophic acne scars. RESULTS: The main themes identified in the qualitative interviews included acceptability to self and others, social functioning, and emotional well-being. In the cross-sectional survey, 31.6%, 49.6%, and 18.8% of the participants had mild, moderate, and severe/very severe acne scarring. The survey revealed that 25.7% of the participants felt less attractive, 27.5% were embarrassed or self-conscious because of their scars, 8.3% reported being verbally and/or physically abused because of their scars on a regular basis, and 15.9% felt that they were unfairly dismissed from work. In addition, 37.5% of the participants believed that their scars affected people's perceptions about them, and 19.7% of the participants were very bothered about hiding their scars daily. Moreover, 35.5% of the participants avoided public appearances, and 43.2% felt that their scars had negatively impacted their relationships. LIMITATIONS: The temporal evaluation of the impact was not estimated. CONCLUSION: Even mild atrophic acne scarring can evoke substantial emotional, social, and functional concerns.
ABSTRACT
Acne is a common cause for post-inflammatory hyperpigmentation (PIH), particularly in patients with skin of color (SOC), and PIH is often more distressing to patients than the acne itself. Topical retinoids are approved for the treatment of acne and for pigmentation disorders such as melasma or mottled hyperpigmentation associated with photodamage; moreover, they have been shown to reduce hyperpigmentation in patients with SOC. Therefore, treatment with topical retinoids should be started as early as possible unless contraindicated. Use of novel formulations or application of commonly recommended moisturizers may help reduce irritation. Combining retinoids with other topical agents and procedures such as superficial chemical peels can help to improve hyperpigmentation. Primary acne lesions are likely to improve weeks before PIH resolves and helping patients manage their expectations may reduce frustration. Providing clinicians and researchers with more education about the presentation and management of dermatologic conditions in patients with SOC is also recommended.
Subject(s)
Acne Vulgaris/drug therapy , Hyperpigmentation/drug therapy , Retinoids/therapeutic use , Skin Pigmentation , Acne Vulgaris/complications , Administration, Topical , Humans , Hyperpigmentation/etiology , Patient Education as Topic , Skin CareABSTRACT
BACKGROUND: Acne affects more than 80% of adolescents and young adults, who most often develop acne scars. Supporting data on the effect of acne scars on patient's health-related quality of life (HRQOL) are limited. OBJECTIVE: The aim was to determine how the severity of acne scars impacts the HRQOL of afflicted individuals. METHODS: In this population-based cross-sectional study, 723 adults with facial acne scars but without active acne lesions self-completed the Self-assessment of Clinical Acne-Related Scars (SCARS) questionnaire formulated to investigate degree of acne scarring. The Facial Acne Scar Quality of Life (FASQoL), Dermatology Life Quality Index (DLQI), and Dysmorphic Concern Questionnaire (DCQ) were completed to assess the attitude of these patients toward their scars and the impact of scarring on their HRQOL. RESULTS: The mean (standard error) DLQI score for facial acne scars was 6.26 (0.22). Acne scars were considered a 'very large' or 'extremely large' concern by 19.3% of participants with mild scars as compared to 20.1% and 34.0% of participants with moderate and severe/very severe scars, respectively (P = 0.003). Higher FASQoL scores were associated with increased severity of scarring (P = 0.001). In total, 16.9% of participants had clinical features of dysmorphia (i.e., DCQ > 13). DCQ scores were significantly higher among participants with more severe scarring (mean DCQ score of 8.04 [0.28], 8.40 [0.18], and 10.13 [0.08] among participants with mild, moderate, and severe/very severe acne scars, respectively; P = 0.001). Most commonly reported signs of emotional distress were self-consciousness (68.0%) and worry about scars not going away (74.8%). CONCLUSIONS: This study highlights the significant psychosocial impact of atrophic acne scars in the form of embarrassment and self-consciousness. Individuals with mild scars also expressed significant impact on quality of life that increased with aggravation of scar severity. Patient-reported outcomes provide an insight into the physical, functional, and psychological impact of acne scarring from the patient's perspective.
Subject(s)
Acne Vulgaris/psychology , Cicatrix/psychology , Quality of Life , Acne Vulgaris/complications , Adolescent , Adult , Cicatrix/etiology , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Young AdultABSTRACT
BACKGROUND: Acne confers an increased risk of physical, psychiatric, and psychosocial sequelae, potentially affecting multiple dimensions of health-related quality of life (HRQoL). Morbidity associated with truncal acne is poorly understood. OBJECTIVE: To determine how severity and location of acne lesions impact the HRQoL of those who suffer from it. METHODS: A total of 694 subjects with combined facial and truncal acne (F+T) and 615 with facial acne only (F) participated in an online, international survey. Participants self-graded the severity of their acne at different anatomical locations and completed the dermatology life quality index (DLQI). RESULTS: The F+T participants were twice as likely to report "very large" to "extremely large" impact on HRQoL (ie, DLQI > 10 and children's DLQI [CDLQI] > 12) as compared with the F participants (DLQI: odds ratio [OR] 1.61 [95% confidence interval {CI} 1.02-2.54]; CDLQI: OR 1.86 [95% CI 1.10-3.14]). The impact of acne on HRQoL increased with increasing acne severity on the face (DLQI and CDLQI P values = .001 and .017, respectively), chest (P = .003; P = .008), and back (P = .001; P = .028). LIMITATIONS: Temporal evaluation of acne impact was not estimated. CONCLUSIONS: Facial and truncal acne was associated with a greater impact on HRQoL than facial acne alone. Increasing severity of truncal acne increases the adverse impact on HRQoL irrespective of the severity of facial acne.
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Since the US Food and Drug Administration (FDA) approved tretinoin in 1971, retinoids alone or combined with other agents have become the mainstay of acne treatment. Retinoids act through binding to retinoic acid receptors, altering expression levels of hundreds of cellular proteins affecting multiple pathways involved in acne pathogenesis. Retinoids have evolved from first-generation agents, such as tretinoin, through chemical modifications resulting in a second generation (etretinate and acitretin for psoriasis), a third generation (adapalene and tazarotene) and, most recently, a fourth (trifarotene). For all topical retinoids, local irritation has been associated with poor tolerability and suboptimal adherence. Efforts to improve tolerability have utilized novel delivery systems and/or novel agents. This qualitative literature review summarizes the evolution of the four topical single-agent retinoids available for the treatment of acne in the US today and their various formulations, presenting the rationale behind their development and data from key studies.
Subject(s)
Acne Vulgaris/drug therapy , Dermatologic Agents/administration & dosage , Retinoids/administration & dosage , Acne Vulgaris/immunology , Administration, Cutaneous , Cell Movement/drug effects , Cell Movement/immunology , Dermatologic Agents/adverse effects , Gene Expression Regulation/drug effects , Gene Expression Regulation/immunology , Humans , Leukocytes/drug effects , Leukocytes/immunology , Receptors, Retinoic Acid/metabolism , Retinoids/adverse effects , Signal Transduction/drug effects , Signal Transduction/immunology , Toll-Like Receptors/metabolism , Treatment OutcomeABSTRACT
Acne vulgaris (acne) is the most common dermatologic disorder seen in black patients. However, data are lacking on the effects of treatments, such as topical retinoids. Acne in black patients is frequently associated with postinflammatory hyperpigmentation (PIH), which can be of greater concern than the patient's acne and often is the main reason these patients seek a dermatologist consultation. Retinoids can treat both acne and PIH. However, the potential for retinoids to induce an irritant contact dermatitis, which could lead to PIH, is a concern. A lotion formulation of tretinoin was developed to provide an important alternative option to treat acne in black patients who may be sensitive to the irritant effects of other tretinoin formulations or where PIH is a concern.
Subject(s)
Acne Vulgaris/drug therapy , Black People , Dermatologic Agents/administration & dosage , Tretinoin/administration & dosage , Administration, Cutaneous , Adolescent , Adult , Child , Dermatologic Agents/adverse effects , Double-Blind Method , Female , Follow-Up Studies , Humans , Hyperpigmentation/drug therapy , Male , Middle Aged , Severity of Illness Index , Skin Cream , Tretinoin/adverse effects , Young AdultABSTRACT
Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups. Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8. Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250.
Subject(s)
Clobetasol/analogs & derivatives , Dermatologic Agents/administration & dosage , Psoriasis/drug therapy , Skin Cream/administration & dosage , Adult , Aged , Clobetasol/administration & dosage , Clobetasol/adverse effects , Dermatologic Agents/adverse effects , Double-Blind Method , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Psoriasis/diagnosis , Severity of Illness Index , Sex Factors , Skin Cream/adverse effects , Treatment OutcomeABSTRACT
Background: Acne vulgaris and inflammation-associated sequelae are highly prevalent in black and Hispanic populations. In a phase 2 study, a novel polymeric emulsion formulation of tazarotene 0.045% lotion had relatively fewer adverse events than tazarotene 0.1% cream, but with comparable efficacy. The objective was to evaluate tazarotene 0.045% lotion by race and ethnicity in the pivotal trials. Methods: In two phase 3, double-blind, 12-week studies (NCT03168334; NCT03168321), participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion (N=1,614). This pooled, post hoc analysis included subsets of participants that self-identified as white (n=1191) or black (n=262) and Hispanic (n=352) or non-Hispanic (n=1262). Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success (defined as at least a 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 'clear' or 'almost clear'). Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were evaluated. Results: At week 12, tazarotene 0.045% lotion led to significantly greater percent reductions in inflammatory and noninflammatory lesions compared with vehicle in white, Hispanic, and non-Hispanic participants (P<0.05, all). Black participants had significantly greater reductions in noninflammatory lesions following treatment with tazarotene 0.045% versus vehicle (P<0.05). Treatment success rates in all subpopulations were higher with tazarotene 0.045% lotion (29.4-34.1%) versus vehicle (16.4-23.1%). TEAE rates were similar across tazarotene-treated groups and most were mild-to-moderate in severity. The incidence of hyperpigmentation decreased in black tazarotene-treated participants from baseline to week 12. Conclusions: Tazarotene 0.045% lotion demonstrated efficacy and was well tolerated across racial and ethnic subpopulations in this pooled analysis. J Drugs Dermatol. 2020;19(7) doi:10.36849/JDD.2020.5125.
Subject(s)
Acne Vulgaris/drug therapy , Keratolytic Agents/therapeutic use , Nicotinic Acids/therapeutic use , Acne Vulgaris/ethnology , Acne Vulgaris/pathology , Administration, Cutaneous , Child , Double-Blind Method , Ethnicity , Female , Humans , Keratolytic Agents/administration & dosage , Male , Nicotinic Acids/administration & dosage , Severity of Illness Index , Skin Cream , Treatment OutcomeABSTRACT
BACKGROUND: There has been an increasing interest in gender differences both in the pathogenesis and treatment of acne vulgaris (acne). However, while acne prevalence among adolescents is comparable across sexes, acne is much more common in adult women than in adult men which has been largely ignored. Acne is likely less common in adult men because of the declining rate of sebum secretion observed with increasing age, and yet it can be more severe than in adult women. In addition, adherence to topical medications is especially poor in adult men where tactile and sensory perceptions are low. The first lotion formulation of tazarotene was developed using polymeric emulsion technology to provide an important alternative option to treat these acne patients, especially those who may be sensitive to the irritant effects of other tazarotene formulations. OBJECTIVE: To evaluate the efficacy and safety of a new tazarotene 0.045% lotion formulation based on polymeric emulsion technology in treating adult male subjects with moderate or severe acne, in comparison with adolescent males treated with the same tazarotene 0.045% lotion. METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate-or-severe acne. Subjects (aged 10 and older, N=1614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear or almost clear). Quality of Life was assessed using the validated Acne-QoL scale. Safety, adverse events (AEs) were evaluated throughout; cutaneous tolerability (using a 4-point scale where 0=none and 3=severe) at each study visit. RESULTS: A total of 268 male subjects (85≥18 years old and 183<18 years old) were treated with tazarotene 0.045% lotion once-daily for 12 weeks. At week 12, percent reductions in inflammatory and noninflammatory lesions with tazarotene 0.045% lotion were 62.3% and 59.5% in the adult male population, compared with 49.4% (P=0.001) and 49.5% (P=0.016) in the adolescent male population. Treatment success was achieved by 33.0% of adult male subjects treated with tazarotene 0.045% lotion, compared with 21.6% in the adolescent male population (P=0.059). Quality of life (as assessed by Acne-QoL domain scores) was better in adolescent males at baseline. Improvements in QoL domain scores were similar to those seen in the overall study population, with greater absolute change in domain scores in the adult males. Improvement in acne symptom scores was significantly greater in adult males (P=0.029). Tazarotene 0.045% lotion was well-tolerated. The number of subjects reporting any AE in the adult male population was 11 (13.6%) compared with 39 (21.4%) in the adolescent male population. There was only one (1.2%) treatment-related AE (application site pain) reported in the adult males compared with 11 (6.0%) in the adolescent males, where the most common treatment-related AEs were application site pain (3.3%), dryness (1.1%), and erythema (1.1%). Mean scores for hyper- and hypopigmentation were very low at baseline in both groups with no appreciable change with treatment. CONCLUSIONS: Tazarotene 0.045% lotion provides greater efficacy and better tolerability in adult males (above 18 years old) than the adolescent male population with moderate-to-severe acne patients. J Drugs Dermatol. 2020;19(1):78-85. doi:10.36849/JDD.2020.3979
Subject(s)
Acne Vulgaris/drug therapy , Dermatologic Agents/administration & dosage , Nicotinic Acids/administration & dosage , Acne Vulgaris/pathology , Administration, Cutaneous , Adolescent , Adult , Age Factors , Child , Dermatologic Agents/adverse effects , Double-Blind Method , Humans , Male , Nicotinic Acids/adverse effects , Quality of Life , Severity of Illness Index , Skin Cream , Treatment Outcome , Young AdultABSTRACT
In 2017, a National Rosacea Society Expert Committee developed and published an updated classification of rosacea to reflect current insights into rosacea pathogenesis, pathophysiology, and management. These developments suggest that a multivariate disease process underlies the various clinical manifestations of the disorder. The new system is consequently based on phenotypes that link to this process, providing clear parameters for research and diagnosis as well as encouraging clinicians to assess and treat the disorder as it may occur in each individual. Meanwhile, a range of therapies has become available for rosacea, and their roles have been increasingly defined in clinical practice as the disorder has become more widely recognized. This update is intended to provide a comprehensive summary of management options, including expert evaluations, to serve as a guide for tailoring treatment and care on an individual basis to achieve optimal patient outcomes.
Subject(s)
Rosacea/diagnosis , Rosacea/therapy , HumansABSTRACT
Background: Acne vulgaris (acne) is the most common dermatologic disease seen in a racially, geographically, politically, culturally, and socioeconomically diverse Hispanic population. Despite their growing demographics in the US, there are few studies evaluating acne treatment in this population. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns. The first lotion formulation of tretinoin was developed using novel polymerized emulsion technology to provide an important alternative option to treat these acne patients who may be sensitive to the irritant effects of other tretinoin formulations. Objective: To determine the efficacy and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in a Hispanic population. Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Hispanic subjects (aged 11 to 50 years, N=766) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator's Global Severity Score [EGSS] and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout using a 4-point scale where 0=none and 3=severe. Results: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 60.1% and 53.0%, respectively, compared with 51.1% and 38.7% with vehicle (P≤0.001) in the Hispanic population. Treatment success was achieved by 19.6% of subjects by week 12, compared with 12.7% on vehicle (P=0.015). The majority of AEs were mild and transient. There were four serious AEs (SAEs) reported (two each group) unrelated to treatment. Incidence of treatment-related AEs with tretinoin 0.05% lotion was lower than in the overall study population; the most frequently were application site pain (2.0%), dryness (1.4%), and erythema (1.2%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate at baseline and improved by week 12. There were slight transient increases in scaling and burning over the first four weeks. Hyperpigmentation severity reduced progressively with treatment. Conclusions: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions in a Hispanic population. The new lotion formulation was well-tolerated, and all treatment-related AEs were both mild and transient in nature. J Drugs Dermatol. 2019;18(1):32-38.
Subject(s)
Acne Vulgaris/drug therapy , Facial Dermatoses/drug therapy , Keratolytic Agents/therapeutic use , Tretinoin/therapeutic use , Acne Vulgaris/ethnology , Acne Vulgaris/pathology , Administration, Cutaneous , Adolescent , Adult , Child , Double-Blind Method , Drug Administration Schedule , Facial Dermatoses/pathology , Female , Hispanic or Latino , Humans , Keratolytic Agents/administration & dosage , Male , Middle Aged , Randomized Controlled Trials as Topic , Severity of Illness Index , Skin Cream/administration & dosage , Skin Cream/therapeutic use , Treatment Outcome , Tretinoin/administration & dosage , Young AdultABSTRACT
BACKGROUND: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks. OBJECTIVE: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis. METHODS: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and 'clear' or 'almost clear') at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. RESULTS: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%. LIMITATIONS: Study did not include subjects with BSA greater than 12. CONCLUSIONS: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.
Subject(s)
Clobetasol/analogs & derivatives , Dermatologic Agents/therapeutic use , Psoriasis/drug therapy , Administration, Cutaneous , Clobetasol/administration & dosage , Clobetasol/therapeutic use , Dermatologic Agents/administration & dosage , Double-Blind Method , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Psoriasis/pathology , Randomized Controlled Trials as Topic , Severity of Illness Index , Skin Cream , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.