Triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel for moderate-to-severe acne in children and adolescents: Randomized phase 2 study.

BACKGROUND/OBJECTIVES: Topical clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel (IDP-126) is the first fixed-dose triple-combination formulation in development for acne. This post hoc analysis investigated efficacy and safety of IDP-126 in children and adolescents with moderate-to-severe acne. METHODS: In a randomized, double-blind phase 2 study (NCT03170388), participants ≥9 years of age with moderate-to-severe acne were eligible for randomization (1:1:1:1:1) to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. This post hoc analysis of pediatric participants (n = 394) included children and adolescents up to 17 years of age. Assessments included treatment success, inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. RESULTS: At Week 12, treatment success rates were significantly greater with IDP-126 (55.8%) than with vehicle (5.7%; p < .001) or any of the dyad combinations (range: 30.8%-33.9%; p < .01, all). Lesion reductions with IDP-126 were also significantly greater than with vehicle (inflammatory: 78.3% vs. 45.1%; noninflammatory: 70.0% vs. 37.6%; p < .001, both) and 9.2%-16.6% greater than with any of the dyad combinations. Increases (improvements) from baseline in Acne-QoL domain scores were generally greater with IDP-126 than in any other treatment group. The most common treatment-related TEAEs across treatment groups were application site pain and dryness. Most treatment-related TEAEs were of mild-to-moderate severity. CONCLUSION: IDP-126 gel-a novel fixed-dose, triple-combination topical formulation for acne-demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate-to-severe acne.

Melanin-dependent tissue interactions induced by a 755-nm picosecond-domain laser: complementary visualization by optical imaging and histology.

Fractional picosecond-domain lasers (PSL) induce optical breakdown, which correlates histologically to vacuolization in the epidermis and dermis. In this ex vivo porcine study, we sought to establish a framework for the investigation of laser-tissue interactions and their dependence on melanin density. Light- (melanin index: 24.5 [0-100]), medium- (58.7), and dark-pigmented (> 98) porcine skin samples were exposed to a 755-nm fractional PSL and examined with dermoscopy, line-field confocal optical coherence tomography (LC-OCT), conventional OCT, and subsequently biopsied for digitally stained ex vivo confocal microscopy (EVCM) and histology, using hematoxylin and eosin (HE) and Warthin-Starry (WS) melanin staining. Dermoscopy showed focal whitening in medium- and dark-pigmented skin. Similarly, LC-OCT and OCT visualized melanin-dependent differences in PSL-induced tissue alterations. Vacuoles were located superficially in the epidermis in dark-pigmented skin but at or below the dermal-epidermal junction in medium-pigmented skin; in light-pigmented skin, no vacuoles were observed. Histology confirmed the presence of vacuoles surrounded by areas void of WS staining and disrupted stratum corneum in darker skin. The combined use of optical imaging for multiplanar visualization and histological techniques for examination of all skin layers may mitigate the effect of common artifacts and attain a nuanced understanding of melanin-dependent laser-tissue interactions.

Vehicle Formulation Impacts Tolerability and Patient Preference: Comparison of Tretinoin Branded Lotion and Generic Cream.

BACKGROUND: Topical retinoids like tretinoin are a mainstay of acne treatment but associated cutaneous irritation and drying may lead to poor adherence. As vehicle optimization can improve patient preference and adherence, tretinoin 0.05% lotion (Altreno®) was formulated using polymeric emulsion technology for uniform delivery of micronized tretinoin and moisturizing/hydrating excipients. This study compared tolerability and participant preference of a branded tretinoin 0.05% lotion versus generic cream. METHODS: In this single-center, double-blind, split-face study, 25 adult females with acne were randomized to apply lotion and cream to opposite cheeks once daily for 2 weeks. Investigator-assessed skin irritation and appearance, as well as participant ratings of the products and skin sensations, were evaluated immediately after first use and after 2 weeks. RESULTS: At week 2, there was significantly greater erythema, scaling, and dryness (122%–144%; P<0.01 each) and decreased skin softness, smoothness, radiance, and brightness (~40% difference; P<0.01 each) on the cream-treated versus lotion-treated side of the face. More participants agreed that the lotion was gentle, comfortable/soothing, spreadable, absorbent, not sticky, and left minimal residue versus cream (range: 72%–92% vs 8%–36%). Agreement scores on skin sensations (eg, soft, not dry, less dull) were similarly higher for lotion versus cream. Overall, ~70% of participants preferred to take home the lotion over the cream. CONCLUSIONS: After 2 weeks of once-daily use, tretinoin 0.05% lotion was associated with less irritation and superior skin appearance/ sensation versus generic 0.05% cream, with most participants preferring the lotion over cream. These results demonstrate the importance of a well-designed vehicle formulation on tolerability and patient preference. J Drugs Dermatol. 2022;21(8): 875-880. doi:10.36849/JDD.6945.

SUPPLEMENT INDIVIDUAL ARTICLES: Update on Truncal Acne: A Review of Treatments for a Neglected Disease and the Re-Emergence of Tazarotene.

Acne vulgaris of the trunk carries with it a major psychosocial impact and an unmet need for adequate management. Approximately 50% of patients with facial acne also exhibit involvement of the back, chest, and/or upper arms. The trunk poses a therapeutic challenge given its occlusion by clothing, the tendency for mechanical rubbing, a sebum physiology that differs from the face, as well as the fact that there is a large surface area for topical therapies to cover. Furthermore, truncal acne is underreported for a variety of reasons such as cultural barriers, sentiments of embarrassment, and prioritization of facial acne. To date, few medications have been studied specifically for truncal acne. In this article, an updated review of truncal acne and available therapies is provided. The most recent evidence for tazarotene, a third-generation retinoid previously approved for psoriasis and facial acne vulgaris over two decades ago, is also reviewed and compared to trifarotene, a fourth-generation retinoid that is the only approved tropical retinoid for both facial and truncal acne. J Drugs Dermatol. 2022;21:12(Suppl):s5-14.

In Vitro Rheology Predicts Improved Spreadability of Tazarotene 0.045% Lotion Versus Trifarotene 0.005% Cream.

BACKGROUND: Intrinsic properties of vehicles used to deliver topical therapies can profoundly impact drug penetration, efficacy, patient acceptance, and treatment adherence. Therefore, advancements in vehicle technology demand sophisticated, quantitative approaches to describe and differentiate topical formulations. The objective of these studies was to quantitatively evaluate spreadability of two topical formulations for the treatment of acne via in vitro rheological measurement (how a substance’s flow characteristics change under applied stress or force) and spreadability on living skin. METHODS: Rheological characteristics (shear-thinning, rigidity, yield stress, and yield strain) of tazarotene 0.045% lotion and trifarotene 0.045% cream were measured using 5 samples of each product. In a clinical split-body study, each formulation was applied to one side of the back of healthy volunteers, and the extent to which each formulation could be spread was measured. RESULTS: Compared to trifarotene cream, tazarotene lotion demonstrated lower mean viscosity, rigidity, and yield stress, and higher yield strain, suggesting a superior spreadability profile. This finding was confirmed in the split-body study of 30 healthy White adults, in which the average area of spread was significantly larger for tazarotene lotion than trifarotene cream (167.0 vs 130.3 cm2; P<0.001). CONCLUSIONS: Rheological assessment effectively predicted the superior spreadability of tazarotene 0.045% lotion versus trifarotene 0.005% cream on living skin. Given the importance of aesthetics of topical formulations, techniques to quantify these properties may have broad implications when developing novel vehicle formulations for dermatology. J Drugs Dermatol. 2022;21(3):250-257. doi:10.36849/JDD.6703.

Tazarotene 0.045% Lotion for Females With Acne: Analysis of Two Adult Age Groups.

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.

Oxymetazoline and Energy-Based Therapy in Patients with Rosacea: Evaluation of the Safety and Tolerability in an Open-Label, Interventional Study.

BACKGROUND AND OBJECTIVES: The objectives of this study were to evaluate the safety, tolerability, and efficacy of oxymetazoline hydrochloride cream, 1% (oxymetazoline) when used as an adjunctive treatment with energy-based therapy for patients with moderate to severe facial erythema associated with rosacea. STUDY DESIGN/MATERIALS AND METHODS: In this Phase 4, multicenter, interventional, open-label study, eligible patients received one of four energy-based therapies (potassium titanyl phosphate laser, intense pulsed light therapy, pulsed-dye laser Vbeam Perfecta, or pulsed-dye laser Cynergy) on day 1 and day 29 and once-daily application of oxymetazoline on days 3 through 27 and days 31 through 56. Improvement from baseline in Clinician Erythema Assessment (CEA) score, patient satisfaction measures, incidence of treatment-emergent adverse events (TEAEs), and worsening from baseline on dermal tolerability assessments and the Clinician Telangiectasia Assessment (CTA) were assessed. Data were summarized using descriptive statistics. RESULTS: A total of 46 patients (mean age, 51.1 years; 78.3% female) enrolled in this study. Similar numbers of patients received each of the energy-based therapies in addition to oxymetazoline. All patients demonstrated an improvement from baseline in CEA during the study with 39 of 43 evaluable patients (90.7%) demonstrating an improvement 6 hours posttreatment on day 56. Most patients were satisfied or very satisfied with treatment at the end of the study. All TEAEs were mild or moderate in severity. Some patients experienced worsening in dermal tolerability assessment symptoms (range: 4-21 patients; 8.7-45.7%). Worsening in CEA and CTA were each reported by three patients (6.5%) at any time during the study. CONCLUSIONS: Treatment with oxymetazoline as adjunctive therapy with energy-based therapy was safe, well tolerated, and reduced facial erythema in patients with moderate to severe persistent facial erythema associated with rosacea. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Tazarotene 0.045% Lotion for Moderate-to-Severe Acne Patients: Pooled Phase 3 Analysis by Age and Sex.

BACKGROUND: Two identical phase 3 trials (NCT03168321 and NCT03168334) and pooled post hoc analyses have established efficacy and safety of a polymeric tazarotene 0.045% lotion formulation in patients with moderate-to-severe acne. Presented here are post hoc analyses that further examine efficacy and safety of tazarotene 0.045% lotion by age and sex. METHODS: Patients aged ≥ 9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were equally randomized to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Efficacy outcomes included inflammatory/noninflammatory lesion counts and treatment success (proportion of participants achieving ≥ 2-grade reduction from baseline in EGSS and score of 0 [clear] or 1 [almost clear]). Adolescent and adult females (n=1,013) and males (n=529) were subdivided into 3 age groups: 13­19, 20­29, and ≥30 years. RESULTS: At week 12, large least-squares mean percent reductions in inflammatory and noninflammatory lesions were observed across all 3 tazarotene-treated age groups in males and females (range, -50.2% to -64.8%). Treatment success rates ranged from 23.6% to 38.4%. Across all efficacy assessments, significant differences between tazarotene and vehicle (P<0.05) were generally observed in the younger male and female participants (13­19 and 20­29). No notable age-related patterns were found for safety outcomes, though tazarotene-treated males of all age groups reported fewer adverse events than females. CONCLUSIONS: Tazarotene 0.045% lotion is efficacious and well tolerated in female and male adolescents and adults with moderate-to-severe acne. J Drugs Dermatol. 2021;20(6):608-615. doi:10.36849/JDD.6070.

Fixed-Combination Halobetasol Propionate/Tazarotene Lotion for Psoriasis in Patients With 3%-5% Affected Body Surface Area.

INTRODUCTION: Patients with psoriasis and low body surface area (BSA) involvement often experience substantially reduced quality of life and may be candidates for topical therapies. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) vs vehicle lotion was evaluated in participants with 3% to 5% BSA involvement. METHODS: In two phase 3, multicenter, double-blind, vehicle-controlled, 8-week studies (ClinicalTrial.gov identifiers: NCT02462070/NCT02462122), adults with moderate/severe investigator’s global assessment (IGA) score were randomized 2:1 to once-daily HP/TAZ or vehicle. Pooled post hoc analyses included participants with baseline BSA involvement of 3% to 5%. Measures included treatment success (≥2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of ≥4 points on dermatology life quality index (DLQI). RESULTS: Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83). At week 8, 42.7% of HP/TAZ-treated participants achieved treatment success, compared with 11.4% of vehicle-treated participants (P< .001). Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P< .001). Larger proportions experienced clinically meaningful DLQI improvements at week 8 with HP/TAZ (64.2%) vs vehicle (47.4%; P< .05). More participants achieved a ≥2-grade improvement in plaque elevation and scaling with HP/TAZ vs vehicle (each comparison, P< .001). Serious adverse events and discontinuations due to treatment-emergent adverse events were rare. CONCLUSIONS: In participants with plaque psoriasis and BSA involvement of 3% to 5%, HP/TAZ provided significantly improved effectiveness after 8 treatment weeks vs vehicle lotion, with clinically meaningful improvements in quality of life. J Drugs Dermatol. 2021;20(8):829-836. doi:10.36849/JDD.6217.

Treatment of Refractory Melasma in Asians With the Picosecond Alexandrite Laser.

BACKGROUND/OBJECTIVES: The picosecond Alexandrite laser was studied in our practice with the diffractive lens array and the flat optic to treat melasma. METHODS AND MATERIALS: Sixty patients with melasma were treated in a prospective investigation with the picosecond Alexandrite laser. Nineteen patients were treated with the flat optic and 41 patients were treated with the diffractive lens array. Treatments were performed with 1 pass at 2-week intervals for 6 treatments. The Melasma Severity Index (MSI) was used to evaluate the patients before treatment and 3 and 6 months after the final treatment session. RESULTS: At 6 months after the last treatment, there was an 18.5% difference between the groups with a 75.7% improvement in the MSI in patients with the diffractive lens array and a 57.2% improvement in the MSI score in patients with the flat optic. At 6 months, there was recurrence of melasma in 5% of the cases with no hyperpigmentation with the diffractive optic in contrast to recurrence in 16% of the cases in the flat optic group and a transient macular hyperpigmentation in 21% of the cases. CONCLUSION: This investigation highlights the utility of a picosecond Alexandrite laser with a flat and diffractive lens to successfully treat a large percentage of Asian patients in a sunny climate.

Efficacy and Safety of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam With Apremilast for Moderate Plaque Psoriasis.

OBJECTIVE: To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis. METHODS: A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician’s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments – Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) – and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16. RESULTS: 28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of “clear” or “almost clear” (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated. CONCLUSIONS: In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.

New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis.

BACKGROUND: Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne. METHODS: In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed. RESULTS: Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P<0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P<0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups. CONCLUSIONS: Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959.

Novel Polymeric Lotion Formulation of Once-Daily Tazarotene (0.045%) for Moderate-to-Severe Acne: Pooled Phase 3 Analysis.

Background: As current tazarotene formulations indicated for acne (0.1%) can cause irritation, a new tazarotene 0.045% lotion formu-lation was developed using polymeric emulsion technology. The objective was to assess efficacy, safety, and tolerability of tazarotene 0.045% lotion in patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies. Methods: Patients aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion applied once daily. Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS) were assessed. Treatment success was defined as a ≥2-grade improvement in EGSS and a score of 'clear'/'almost clear'. Adverse events (AEs) and cutaneous safety and tolerability were also assessed. Results: In total, 1614 patients (mean age: 20.5 years) were randomized to tazarotene 0.045% lotion (n=799) or vehicle (n=815). At week 12, tazarotene 0.045% lotion demonstrated statistically significant superiority versus vehicle in reducing inflammatory and non-inflammatory lesion counts (least-squares mean percent changes from baseline: inflammatory, -57.9% vs -47.8% [P<0.001]; noninflam-matory, -56.0% vs -42.0% [P<0.001]). Treatment success at week 12 was also greater with tazarotene 0.045% lotion versus vehicle (30.4% vs 17.9%; P<0.001). The most frequent treatment-emergent AEs related to tazarotene treatment were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). Conclusions: The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies. J Drugs Dermatol. 2020;19(3):272-279. doi:10.36849/JDD.2020.4869.

Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials

BACKGROUND: Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne), with data suggesting that is one of the most potent topical retinoids. Irritation from the cream, foam, and gel formulations has limited its use in clinical practice. OBJECTIVE: To assess the efficacy, safety, and tolerability of a unique tazarotene 0.045% lotion formulation based on polymeric emulsion technology in subjects with moderate or severe acne. Methods: A total of 1614 subjects, 9 years and older were randomized to receive tazarotene 0.045% lotion or vehicle in two identical double-blind, randomized, vehicle-controlled 12-week studies evaluating safety and efficacy (inflammatory [papules and pustules] and noninflammatory [comedonal] lesion counts and using Evaluator Global Severity Scores [EGSS]). Treatment success was defined as at least a 2-grade improvement in EGSS and 'clear'/'almost clear' and efficacy assessed through reduction in lesion counts. In addition, patients completed a validated Acne-Specific Quality of Life (Acne-QoL) questionnaire. Safety, adverse events (AEs), and cutaneous tolerability were assessed throughout. RESULTS: Tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts at week 12. Mean percent reductions in inflammatory and noninflammatory lesions were 55.5% and 51.4% (Study 1, both P<0.001 versus vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.045% lotion at week 12. Treatment success was achieved by 25.5% (Study 1) and 29.6% (Study 2) of subjects treated with tazarotene 0.045% lotion (both P<0.001 versus vehicle [13.0% and 17.3%, respectively]). Improvements in QoL domain scores were consistently greater with tazarotene. Tazarotene 0.045% lotion was well-tolerated. The most common treatment-related AEs were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). CONCLUSION: Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. JJ Drugs Dermatol. 2020;19(1):70-77. doi:10.36849/JDD.2020.3977

The Role of Topical Retinoids in Prevention and Treatment of Atrophic Acne Scarring: Understanding the Importance of Early Effective Treatment

Atrophic acne scarring is a frequent occurrence among acne patients. These facial marks are often very emotionally distressing for the patient and can result in adverse impact to quality of life. While most clinicians consider scarring as a sequela of moderate to severe acne, recent studies have found that scars are also associated with mild acne. Risk factors include time to effective treatment, severity of acne, family history, and excoriations. New data shows that early and effective acne treatment can reduce the development of new scars, confirming the widespread perception of this approach in prevention. It is also becoming clear that the inflammatory process drives both the development of acne lesions and atrophic scars. This implies that inhibiting activation of inflammatory pathways early is key to preventing scars. Data also suggests a useful role for adapalene for the treatment of well-established acne scars with scar remodeling accompanied by the production of new collagen and elastic tissue. Acne guidelines and recommendations continue to highlight the central role of retinoids, with fixed-dose combination retinoids being particularly important due to targeting of multiple inflammatory pathophysiologic factors and for patient convenience. Higher concentrations of retinoids such as adapalene 0.3%/benzoyl peroxide 2.5% (A0.3/BPO2.5) have shown increased efficacy, particularly among patients with moderately severe and severe acne ­ a population at high risk for scarring. Further, controlled study of A0.3/BPO2.5 in patients with moderate acne (mean, 40 acne lesions per half face) and mild-moderate scarring demonstrated A0.3/BPO2.5 was significantly superior to vehicle in reducing scar counts from baseline over 24 weeks. While scar counts lessened on the A0.3/BPO2.5 side, counts increased on the vehicle side during the study. This occurred in the setting of active acne, where the efficacy of A/BPO is well known, emphasizing the dual actions of A0.3/BPO2.5 in both treatment and prevention. J Drugs Dermatol. 2019;18(3):255-260.

Truncal Acne: A Neglected Entity

Truncal acne ­ acne vulgaris involving the chest, back, or shoulders ­ is thought to be present in more than half of patients with acne. Because the study of acne has been focused on the face, there are sparse data in the literature about the clinical characteristics and management options for truncal acne. It is thought that the pathogenic process is similar between the face and the back, suggesting that treatments studied on the face may be suitable for use on the back. It is not uncommon for patients to omit discussion of truncal acne with their treating physician, and it is likely that non-facial acne is under-diagnosed and under-treated. Scarring and pigmentary problems are common sequelae of acne on the trunk, underscoring the need for early and effective treatment as a preventive measure. Truncal acne merits consideration and should be more thoroughly studied. Initiating treatment with a topical retinoid combined with an antimicrobial agent is logical for most patients with truncal acne, and mirrors recommendations for facial acne; however, there are additional considerations for truncal acne such as extension of the lesions, risk of antibiotic resistance due to large surface areas treated for a prolonged duration, accessibility of lesions, and discoloration of clothing or bedding due to topical products. Oral isotretinoin is the treatment of choice when truncal acne is severe. This article reviews available information as well as recent recommendations for treatment. J Drugs Dermatol. 2019;18(12):1205-1208.

A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle-Controlled Clinical Study to Compare the Safety and Efficacy of a Novel Tazarotene 0.045% Lotion and Tazarotene 0.1% Cream in the Treatment of Moderate-to-Severe Acne Vulgaris

Background: Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne). Irritation potential has limited its use. Objective: To compare efficacy, safety, and tolerability of a novel formulation tazarotene 0.045% lotion based on polymeric emulsion technology, and tazarotene 0.1% cream in patients with moderate-to-severe acne. Methods: A total of 210 patients, 12 years and older were randomized to receive tazarotene 0.045% lotion, tazarotene 0.1% cream, or respective vehicle in double-blind, randomized, vehicle-controlled, 12-week study evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), and acne-specific quality of life (QoL) questionnaire. Safety and cutaneous tolerability were assessed throughout. Results: A novel tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (P=.006 and P<.001) and clearly more effective in treatment success at week 12. In addition, at less than half the concentration, tazarotene 0.045% lotion was numerically more effective than tazarotene 0.1% cream. Mean percent reductions in inflammatory and noninflammatory lesions were 63.8% and 56.9%, compared with 60.0% and 54.1% with tazarotene 0.1% cream at week 12. Treatment success assessed by the investigator or patients' self-assessment was also numerically greater with tazarotene 0.045% lotion. There were no significant differences in patient satisfaction or QoL between the two active treatments. Both were well-tolerated, however, there were more treatment-related adverse events with tazarotene 0.1% cream (5.6% versus 2.9%); most common being application site pain. Limitations: This study was primarily designed to direct the phase 3 program and some of the results are post hoc analyses. Conclusions: A novel tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction, and numerically better treatment success than tazarotene 0.1% cream; with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2019;18(6):542-548.

WITHDRAWN: Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 2 phase 3, 29-day, randomized, controlled REVEAL trials.

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Tazarotene Revisited: Safety and Efficacy in Plaque Psoriasis and Its Emerging Role in Treatment Strategy

Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. While significant data on tazarotene in psoriasis has been available for over 20 years, its main utility is in acne. Objective: To review the clinical studies with tazarotene in psoriasis and establish its future role in the management of this chronic, incurable condition. Methods: An English language literature review was performed utilizing Medline, EMBASE, and the Web of Science to identify relevant articles, both clinical trials and reviews. Results: Tazarotene is a very effective treatment for plaque psoriasis, with significant reductions in both plaque elevation and scaling after 12 weeks. Efficacy appears to be dose and formulation dependent, and erythema less responsive. Tazarotene sustains clinical response posttreatment and may have an important role in maintenance therapy. The most common side effect is mild-to-moderate local irritation, which limited its role as a single agent for psoriasis. Efficacy is enhanced through combination with topical corticosteroids (TCS). Tazarotene may circumvent the problem of TCS tachyphylaxis, due to its sustained efficacy and provide tolerability benefits; tazarotene increases epidermal thickness and may reduce the risk of steroid-induced atrophy. In addition, tazarotene-induced irritation is reduced by the anti-inflammatory effect of TCS. A new fixed combination, well-tolerated tazarotene/halobetasol topical formulation is now available, which provides synergistic efficacy that is both rapid and sustained posttreatment. Conclusions: Tazarotene is a highly effective psoriasis treatment whose efficacy and tolerability can be enhanced through combination therapy with TCS, and a new fixed combination topical formulation of tazarotene and halobetasol may provide an optimal management approach. J Drugs Dermatol. 2018;17(12):1280-1287.

Tazarotene Revisited: Safety and Efficacy in Plaque Psoriasis and Its Emerging Role in Treatment Strategy

Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. While significant data on tazarotene in psoriasis has been available for over 20 years, its main utility is in acne. Objective: To review the clinical studies with tazarotene in psoriasis and establish its future role in the management of this chronic, incurable condition. Methods: An English language literature review was performed utilizing Medline, EMBASE, and the Web of Science to identify relevant articles, both clinical trials and reviews. Results: Tazarotene is a very effective treatment for plaque psoriasis, with significant reductions in both plaque elevation and scaling after 12 weeks. Efficacy appears to be dose and formulation dependent, and erythema less responsive. Tazarotene sustains clinical response posttreatment and may have an important role in maintenance therapy. The most common side effect is mild-to-moderate local irritation, which limited its role as a single agent for psoriasis. Efficacy is enhanced through combination with topical corticosteroids (TCS). Tazarotene may circumvent the problem of TCS tachyphylaxis, due to its sustained efficacy and provide tolerability benefits; tazarotene increases epidermal thickness and may reduce the risk of steroid-induced atrophy. In addition, tazarotene-induced irritation is reduced by the anti-inflammatory effect of TCS. A new fixed combination, well-tolerated tazarotene/halobetasol topical formulation is now available, which provides synergistic efficacy that is both rapid and sustained posttreatment. Conclusions: Tazarotene is a highly effective psoriasis treatment whose efficacy and tolerability can be enhanced through combination therapy with TCS, and a new fixed combination topical formulation of tazarotene and halobetasol may provide an optimal management approach. J Drugs Dermatol. 2018;17(12):1280-1287.