Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants With Moderate-to-Severe Acne: The Patient Journey.

INTRODUCTION: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In 3 clinical studies of participants with moderate-to-severe acne, CAB demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Detailed efficacy/safety data from individual clinical study participants are presented. METHODS: In two phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged at least 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Descriptive data - including lesion count changes, treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin), compliance, treatment-emergent adverse events (AEs), and cutaneous safety/tolerance assessments - were summarized from 6 CAB-treated cases. RESULTS: By week 12, all cases achieved >70% lesion reductions, 4/6 achieved treatment success, and 1/6 achieved a 2-grade reduction in severity. All cases were compliant with CAB treatment. No cases reported serious AEs. Transient increases occurred on cutaneous safety and tolerability assessments, with scores generally decreasing back to/below baseline levels by week 12. CONCLUSIONS: In two phase 3 clinical trials, fixed-dose, triple-combination CAB demonstrated good efficacy/safety. All 6 CAB-treated cases achieved substantial (>70%) lesion reductions, with 5/6 achieving treatment success or 2-grade reduction in severity by week 12. Transient cutaneous safety/tolerability severity increases generally resolved to baseline values by week 12. These clinical study cases reinforce the importance of patient education regarding adherence, expectations, and AEs. J Drugs Dermatol. 2024;23(11):1017-1024. doi:10.36849/JDD.8639.

Benefit of Topical Combination Therapy for Acne: Analyzing Effect Size Using Number Needed to Treat.

BACKGROUND: Topical acne trials often are confounded by high vehicle response rates and differing outcome measures, making it difficult to compare treatments. Number needed to treat (NNT) can be a simple, clinically meaningful way to indirectly compare treatment options without head-to-head data. NNT is the number of patients who need to be treated with an intervention to observe one additional patient successfully achieving a desired outcome versus vehicle/placebo. While treatment attributes such as adverse events may not be captured, lower NNT is a good indicator of a more effective treatment. METHODS: Following a search of combination topical treatments for acne vulgaris, all treatments that reported pivotal trial efficacy data consistent with the 2018 FDA definition of success were included in NNT analyses.  Results: Of 13 treatments, 7 reported 12-week treatment success rates in 11 phase 3 trials, with similar baseline demographics/disease severity. Treatment success ranged from 26.8% with tretinoin 0.1%/benzoyl peroxide (BPO) 3% cream to 50% with triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel. NNTs for the triple-combination gel were 4 and 5 (from 2 pivotal trials). Adapalene 0.3%/BPO 2.5% gel had an NNT of 5. Tretinoin/BPO had the largest range between trials, with NNTs of 4 and 9. The other 4 treatments had NNTs ranging from 6 to 8. CONCLUSION: A comparison of combination topical acne treatment trial data, using the same treatment outcome and similar patient populations, resulted in triple-combination clindamycin phosphate/adapalene/BPO gel and adapalene/BPO gel having the most favorable NNTs.J Drugs Dermatol. 2024;23(2):42-49.  doi:10.36849/JDD.7927.

Dermal sensitization, safety, and tolerability of triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel from three clinical trials.

BACKGROUND: Using a three-pronged acne treatment approach-combining an antibiotic, antimicrobial agent, and retinoid-may provide greater efficacy than monad or dyad treatments. Herein are the dermal sensitization, irritation, safety, and tolerability results from phase 1 and 2 studies of fixed-dose clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) polymeric mesh gel. METHODS: Two phases 1, single-blind, vehicle-controlled dermal safety studies were conducted in healthy participants aged ≥18 years. One phase 2 (NCT03170388) double-blind, randomized, parallel-group, and vehicle-controlled study was conducted over 12 weeks in participants aged ≥9 years with moderate-to-severe acne. RESULTS: A total of 1,020 participants (IDP-126 gel, vehicle, or 1 of the 3 dyad gels [phase 2 only]) were included across the 3 studies (safety populations: n = 1,004). In the phase 1 studies, IDP-126 had no confirmed sensitization or contact dermatitis. IDP-126 (deemed "moderately irritating") was significantly less irritating than commercially available BPO 2.5%/adapalene 0.3% gel. CONCLUSIONS: The results from these three studies show that the triple-combination IDP-126 had a positive safety profile and was well tolerated in healthy participants and those with moderate-to-severe acne.

Improvements in acne and skin oiliness with tazarotene 0.045% lotion in patients with oily skin.

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.

Objective Evaluation of Skin Sensitivity Across Fitzpatrick Skin Types.

Context: Skin sensitivity may be best defined as self-reported intolerance to application of skincare products. It is commonly believed that individuals with darker skin are generally less sensitive, while those lighter skin are more sensitive. However, there is little objective data correlating sensitivity with skin type or with objective measures of sensitivity. Objective: This study assessed Fitzpatrick skin type and self-reported perception of skin sensitivity. Design: A single-blinded, lactic acid sting test was performed on the medial cheeks, where patients were randomized to receive room temperature 10% lactic acid on the left or right cheek with water applied to the contralateral cheek as a control. Outcome Measures: Stinging was assessed 1 minute after application of test solution to one cheek using a visual analogue scale (VAS). Results: There was a statistically significant difference in self-reported skin sensitivity in patients with Fitzpatrick skin types 1-3 vs 4-6 (73.6% vs 46.5%; P= 0.006). Patients who had higher perceived sensitivity were more likely to have objectively measured sensitivity as well, across all skin types (P<0.01). When stratified by skin type, a numerically higher percentage of subjects with Fitzpatrick skin types 1-3 experienced objective sensitivity compared to subjects with skin types 4-6 (45.6% vs 27.9; P=0.058). Conclusions: Patients with self-perceived skin sensitivity were more likely to develop objective stinging compared to those who did not report sensitivity. Skin sensitivity can occur across all skin types, and patients should be asked about self-perceptions of sensitivity as it is likely an indicator of true sensitivity. J Drugs Dermatol. 2020;19(7): doi:10.36849/JDD.2020.5880.

Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: assessment of safety and tolerability in subgroups.

Background: Topical tretinoin's role in acne has been established through evidence-based guidelines. Cutaneous irritation and potential to cause or exacerbate postinflammatory hyperpigmentation (PIH) may limit use.Objective: Evaluate safety and tolerability of novel polymeric formulation of tretinoin 0.05% lotion in moderate-to-severe acne.Methods: One thousand six hundred and forty patients randomized to tretinoin 0.05% lotion or vehicle in two double-blind placebo-controlled 12-week studies. Investigator-evaluated cutaneous safety (erythema and scaling) and patient-reported tolerability (itching, burning/stinging) assessed using a scale of 0 (none) to 3 (severe). Hyper- and hypo-pigmentation evaluated at each study visit. A number of subpopulations were investigated.Results: Tretinoin 0.05% lotion was considered safe and very well tolerated. Only application site pain (3.1%), dryness (3.7%) and erythema (1.4%) were reported by >1% or patients. Treatment-related adverse events were particularly rare (≤2%) in Hispanic and male subpopulations, and lower in adult females. The severity of cutaneous safety and tolerability scores remained <0.5 (where 1 = mild) and were generally lower than baseline severity. Tretinoin 0.05% lotion did not appear to cause or exacerbate PIH.Conclusions: A novel polymeric formulation of tretinoin 0.05% lotion provides a highly favorable safety and tolerability profile, with an incidence of erythema, dryness, and skin burning lower than that previously reported with other formulations of tretinoin.

Dermatologist Use of Intralesional Triamcinolone in the Treatment of Acne.

OBJECTIVE: Despite common administration of intralesional triamcinolone to acne lesions, there is little published data or consensus on best practices. This study aimed to evaluate specific characteristics of intralesional triamcinolone for acne among various dermatology healthcare professionals. DESIGN: One hundred participants (82 attending physicians, 9 physician assistants, 8 other healthcare professionals, and 1 unidentified) from private practices and academic centers completed a 10-question survey to assess specific characteristics of intralesional triamcinolone injections, including frequency, indication, depth of injection, concentration, volume, as development of adverse events. RESULTS: The most common reported concentration of intralesional triamcinolone was 2.5mg/mL (52.5%). The most frequently used volume injected was 0.05mL (42.3%). In total, 61.6 percent of those surveyed answered that they inject into the center of the lesion. Additionally, 50.5 percent of respondents counsel patients on potential adverse effects of hypopigmentation and atrophy before every injection. The majority of respondents (88.8%) reported that less than one percent of their patients returned for adverse events resulting from triamcinolone usage, and 48.4 percent reported that atrophy lasted over six months (48.4%). CONCLUSION: The data collected from this study can offer guidance on best practices in administering intralesional kenalog to patients. While consistency exists for the concentration of triamcinolone used, there was significant discordance in the volumes and depth of triamcinolone injection. Observed skin atrophy rates are extremely low, but they are long lasting when it occurred. We can use these data to refine our treatment techniques as well as improve treatment outcomes and patient satisfaction.

Clinical Experience With Once-Daily Dapsone Gel, 7.5% Monotherapy in Patients With Acne Vulgaris.

BACKGROUND: Dapsone gel, 7.5% is a topical medication approved for acne in patients aged 12 years and older. Clinical trials have demonstrated the safety and efficacy of once-daily dapsone gel, 7.5% in patients with moderate acne. OBJECTIVE: The objective of this report is to describe the clinical course of 8 patients who participated in a 12-week program using once-daily dapsone gel, 7.5% as monotherapy for acne in a real-world clinical setting. MONOTHERAPY PROGRAM: Male and female adults and adolescents with facial acne, representing a broad range of ages, skin phototypes, and ethnicities, and with no prior use of dapsone gel, 7.5% applied the product once daily for 12 weeks as monotherapy for acne. Photographs were taken at baseline and at 12 weeks. The treating dermatologists recorded observations of baseline disease, treatment tolerability, and outcomes. An independent rater assessed Global Acne Assessment Score (GAAS) at baseline and at 12 weeks based on photographs. Patients provided testimonials of their experience with treatment. PROGRAM OUTCOMES: Acne improvement was evident in the photographs of the 8 patients. Changes in GAAS at week 12 of treatment, as assessed by an independent rater, ranged from 1- to 3-grade improvement from baseline. CONCLUSION: Photographs, dermatologist reports, and patient commentary in an office-based practice demonstrated that 12 weeks of treatment with only topical dapsone gel, 7.5%, applied once daily, was effective and well tolerated as a stand-alone treatment in 8 patients with facial acne vulgaris, with results that are consistent with the phase 3 pivotal trials. J Drugs Dermatol. 2018;17(6):602-608.

Quality of Life in Individuals with Erythematotelangiectatic and Papulopustular Rosacea: Findings From a Web-based Survey.

OBJECTIVE: The objective of the study was to evaluate the impact of rosacea on self-perception, emotional, social, and overall well-being and quality of life in individuals with erythematotelangiectatic rosacea (ETR) and papulopustular rosacea (PPR). DESIGN: We distributed a cross-sectional email invitation for participants in the United States to fill out a web-based survey. PARTICIPANTS: We included adults who reported having previously received a diagnosis of erythematotelangiectatic rosacea or papulopustular rosacea. MEASUREMENTS: Questionnaires measured the psychosocial aspects of rosacea, including the Satisfaction With Appearance Scale and modified Satisfaction With Appearance Scale questionnaires, Impact Assessment for Rosacea Facial Redness, Rosacea-Specific Quality-of-Life questionnaire, and RAND 36-Item Short Form Health Survey. The Impact Assessment for Rosacea Facial Bumps or Pimples was administered to the papulopustular rosacea cohort. RESULTS: Six hundred participants enrolled and completed the survey, with most rating their rosacea as mild or moderate (ETR: 95.6%; PPR: 93.7%). In the erythematotelangiectatic rosacea and papulopustular rosacea cohorts, respectively, 45 and 53 percent disagreed/strongly disagreed that they were satisfied with their appearance due to rosacea; 42 and 27 percent agreed/strongly agreed that they "worry how people will react when they see my rosacea"; and 43 and 59 percent agreed/strongly agreed that they feel their rosacea is unattractive to others. Rosacea-Specific Quality-of-Life total and domain scores indicated negative impact of rosacea for both cohorts. Both cohorts reported worse 36-item Short Form Health Survey overall and domain scores than population norms in the United States. CONCLUSION: Rosacea had wide-ranging, negative effects on self-perceptions and emotional, social, and overall well-being as well as rosacea-specific quality of life. Overall, both erythematotelangiectatic rosacea and papulopustular rosacea cohorts reported a substantial negative impact of rosacea on quality of life on a range of instruments.

The Use of an Over-the-Counter Hand Cream With Sweet Almond Oil for the Treatment of Hand Dermatitis.

Hand dermatitis is estimated to affect greater than 15% of the general population. Childhood eczema, frequent hand washing, and occupational exposure to chemicals are predisposing factors. Hand dermatitis treatment involves both prevention of outbreaks and treatment of active disease. Moisturizers are essential to protect the skin from the environment, enhance hydration, and repair the skin barrier. They have been shown in large studies to prevent occupational related breakouts. Natural oils are commonly used in moisturizers for their moisturizing and emollient properties. Sweet almond oil is an oil that contains high levels of fatty acids and has been used for centuries to treat skin diseases such as eczema and psoriasis. In this study, a moisturizer with 7% sweet almond oil and 2% colloidal oatmeal was found to be both safe and effective in treating patients with moderate to severe hand dermatitis.

J Drugs Dermatol. 2018;17(1):78-82.

Emerging Issues in Adult Female Acne.

Acne vulgaris (acne) is a common affliction in adolescence and is a growing problem in adult women. Despite an increasing awareness of acne in the adult female population, there is a lack of good prospective studies assessing the severity, distribution, and differential response to treatment in this group. The long-held dogma that acne in adult women develops on the lower one-third of the face has been recently challenged, and here the authors critically review data from available literature. Moreover, while adult female acne has traditionally been defined as disease in women over age 25, it is the authors' experience that this group is subdivided into women ages 25 to 44 years, separate from perimenopausal patients, ages 45 years and up. While there is no data specifically comparing these two groups, the authors will review the existing data and provide practical recommendations based on our experience in treating these groups of patients. Finally, while there is a lack of data on this subject, it is the group's opinion that adherence to medication regimens is likely higher in women than men, which influences therapeutic outcomes.

Acne and the Internet.

The Internet provides both education and miseducation for acne patients. Although some sites provide disease background information and objective treatment guidance, support networks, and research findings, others may seem to be objective on the surface, but are in reality run by untrained, self-proclaimed experts or are promotional in nature. Providers must be aware of the potential benefits and pitfalls the Internet provides for those suffering with acne.

The Clinical Relevance of Antibiotic Resistance: Thirteen Principles That Every Dermatologist Needs to Consider When Prescribing Antibiotic Therapy.

Antibiotics are commonly used by dermatologists in clinical practice, primarily because of the overall track record of favorable efficacy and safety with the most commonly used agents. During the past decade, increased attention has been given to the problems associated with antibiotic resistance. This article summarizes important principles gleaned from the continued efforts of the Scientific Panel on Antibiotic Use in Dermatology; other groups working diligently in this area, such as the Centers for Disease Control and Prevention and the Canadian Antimicrobial Resistance Alliance; and from the published literature.

When Acne is Not Acne.

Acne vulgaris (AV) is considered a straightforward diagnosis made clinically without specific diagnostic testing. However, certain disorders may simulate AV, such as multiple small epidermal cysts or deep milia, multiple osteoma cutis, multiple small adnexal neoplasms, and follicular and/or infections characterized by multiple small papules and/or pustules such as gram-positive folliculitis, gram-negative folliculitis, Malassezia folliculitis, keratosis pilaris, and flat warts. This can lead to an erroneous diagnosis and improper management. Acneiform eruptions, often associated with ingestion of certain drugs and chemicals, can confound the clinician regarding AV diagnosis. We present herein an interesting case that was originally misdiagnosed as AV.

Inflammatory Acne Treatment: Review of Current and New Topical Therapeutic Options.

Acne vulgaris (AV) is an inflammatory skin disease characterized by the presence of comedones, papules, pustules, and nodules. Consensus guidelines recommend the use of combination therapy using different drugs with complementary mechanisms of action to best address as many acne pathogenic factors as possible at the same time. Topical acne medications exist as individual agents that may be combined in physician-recommended regimens or as pre-formulated fixed-dose combination products. In addition, there are several new and promising topical therapies currently being developed that work by different mechanisms of action from traditionally used acne therapies. The following review will cover commonly used drugs, newcomers to the market, and what the future holds for the topical treatment of AV.

Rejuvenating Hydrator: Restoring Epidermal Hyaluronic Acid Homeostasis With Instant Benefits.

Skin aging is a combination of multifactorial mechanisms that are not fully understood. Intrinsic and extrinsic factors modulate skin aging, activating distinctive processes that share similar molecular pathways. One of the main characteristics of youthful skin is its large capacity to retain water, and this decreases significantly as we age. A key molecule involved in maintaining skin hydration is hyaluronic acid (HA). Concentration of HA in the skin is determined by the complex balance between its synthesis, deposition, association with cellular structures, and degradation. HA bio-equivalency and bio-compatibility have been fundamental in keeping this macromolecule as the favorite of the skincare industry for decades. Scientific evidence now shows that topically applied HA is unable to penetrate the skin and is rapidly degraded on the skin surface. SkinMedica's HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles. Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.

The Use of Lipohydroxy Acid in Skin Care and Acne Treatment.

Lipohydroxy acid is a derivative of salicylic acid with unique properties that explain its clinical effects in the skin. Lipohydroxy acid has skin renewing, exfoliating, and acne treating properties and is a commonly used ingredient in personal skin care products. The slow penetration of lipohydroxy acid results in an individual cell-by-cell exfoliation that is associated with excellent tolerability. Lipohydroxy acid has been shown to induce dermal thickening by stimulating glycosaminoglycans, collagen, and elastin production. Finally, lipohydroxy acid has been demonstrated to possess comedolytic properties. This article reviews the available data on the use of lipohydroxy acid in treating aging skin and acne.

Multivesicular Emulsion Ceramide-containing Moisturizers: An Evaluation of Their Role in the Management of Common Skin Disorders.

Proper stratum corneum function plays a pivotal role in maintenance of skin health, and improper function leads to skin disease. The stratum corneum is comprised of corneocytes surrounded by intercelluar lipids including ceramides, free fatty acids, and cholesterol. Ceramide predominant moisturizers have become a mainstay of treatment of skin disease. New technologies for delivery of ceramides include multivesicular emulsions, which deposit ceramides in a timerelease manner for a continuous rather than burst effect. Here, the authors review the available data on the use of multivesicular emulsion ceramide moisturizers in various skin diseases.