Clinical Evaluation of Next-generation, Multi-weight Hyaluronic Acid Plus Antioxidant Complex-based Topical Formulations with Targeted Delivery to Enhance Skin Rejuvenation.

Introduction: Hyaluronic acid (HA) has become a commonly used ingredient in many topical products due to its strong humectant properties and essential role in skin hydration; however, limitations of delivery of HA to only the surface of skin has hindered leveraging the full capacity of HA biology necessary for skin rejuvenation. Here, we describe the clinical efficacy data of a set of novel next-generation, multi-weight HA plus antioxidant complex-based topical formulations with targeted skin delivery to enhance skin rejuvenation. Methods: Four multi-weight HA plus antioxidant complex-based formulations: 1) Multi-Weight HA plus Antioxidant Complex Lotion with SPF 30 (Day Lotion); 2) Multi-Weight HA plus Antioxidant Complex Cream (Night Cream); 3) Multi-Weight HA plus Antioxidant Complex Gel Cream; and 4) Multi-Weight HA plus Antioxidant Complex Boost Serum were clinically evaluated for key attributes including moisturization via corneometer, with clinical grading of: dryness, roughness, fine lines and wrinkles, and following daily use of the individual products for up to eight weeks. Results: Daily use of the multi-weight HA plus antioxidant complex-based formulations demonstrated significant improvements in all parameters evaluated compared to baselines, with changes in moisturization observed within 30 minutes of application, and changes in clinical grading parameters of dryness, roughness, fine lines and wrinkles observed as early as two weeks. Conclusion: These data demonstrate the clinical benefits of daily use of multi-weight HA plus antioxidant complex-based moisturizers for overall improvement in skin health and appearance.

Efficacy and Tolerability of Topical 0.1% Stabilized Bioactive Retinol for Photoaging: A Vehicle-Controlled Integrated Analysis.

INTRODUCTION: Chronic exposure to ultraviolet light photoages skin. Retinol, a precursor molecule to retinoic acid that causes less irritation, is available as a nonprescription, cosmetic retinoid and improves collagen production, skin elasticity, and signs of photoaging. Advances in formulation science have allowed the production of stabilized bioactive retinol formulations. This integrated analysis aims to build on previous studies and further examine the comprehensive efficacy and tolerability of topical 0.1% stabilized bioactive retinol. METHODS: This analysis included 6 vehicle-controlled studies of 0.1% stabilized bioactive retinol in women with mild-to-moderate signs of photodamage. Across all studies, the same dermatologist investigator assessed overall photodamage; wrinkles on the forehead, cheeks, and undereye area; crow’s feet wrinkles and fine lines; lack of even skin tone; and brown spots at baseline and weeks 4, 8, and 12 on a numerical scale. Tolerability was also assessed. RESULTS: Participants (retinol, N=237; vehicle, N=234) had a mean (SD) age of 47.4 (6.6) years. Retinol induced greater improvements from baseline in all signs of photoaging vs vehicle as early as week 4 and through 12 weeks of application. Few participants experienced irritation; all events were mild to moderate and transient. The most common signs of irritation were erythema (n=2) and skin scaling/peeling (n=5). CONCLUSIONS: This pooled analysis of 6 vehicle-controlled clinical studies provides new evidence for the efficacy of 0.1% stabilized bioactive retinol in improving signs of photoaging without causing major irritation. Topical 0.1% stabilized bioactive retinol was well tolerated with only a few reported cases of skin irritation. J Drugs Dermatol. 2024;23(4):     doi:10.36849/JDD.8124.

Evaluation of Antioxidants' Ability to Enhance Hyaluronic-acid Based Topical Moisturizers.

Background: Hyaluronic acid (HA) is a unique molecule of the extracellular matrix with multiple biological activities. In skin, HA plays an essential role as a humectant, capable of binding up to 1,000 times its mass with water, providing skin with moisture and viscoelastic properties. HA concentration and synthesis decrease significantly in aging skin, due to exogenous and endogenous factors, including photoaging and HA metabolism. A key driver for HA degradation and reduced concentration is mediated via induction of reactive oxygen species (ROS) and other free radicals. Objective: In this study, we evaluate antioxidant ingredients essential in the development of next-generation HA-based topical formulations aimed at leveraging HA's ability to maximize anti-aging properties. Methods: Two antioxidants, glycine saponin (Glycine soja germ extract) and glycyrrhetinic acid (enoxolone), were evaluated for stimulation of endogenous HA production and inhibition of endogenous hyaluronidase activity, respectively. Results: The antioxidant glycine saponin induced endogenous HA synthesis in fibroblasts, while the antioxidant glycyrrhetinic acid decreased the degradation rate of HA by 54 percent. Conclusion: While HA has been included in numerous topical skin products, critical aspects of HA metabolism, especially in aging skin, have often been overlooked, including decreases in HA synthesis with increasing age, and increases in HA degradation mediated by exogenously induced reactive oxygen species and free radicals and increased enzymatic degradation by endogenous hyaluronidases. Here, we describe a unique approach to inclusion of two antioxidants essential for the development of the next generation of antioxidant complex-based topical skin formulations to limit the signs of aging skin.

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.

Adult, adolescent, and caregiver preferences for attributes of topical treatments for mild-to-moderate atopic dermatitis: a discrete-choice experiment.

Purpose: Topical treatments for mild-to-moderate (MM) atopic dermatitis (AD) include emollients, corticosteroids, calcineurin inhibitors, a Janus kinase inhibitor, and a phosphodiesterase 4 inhibitor, which differ in multiple ways. This study aimed to quantify the conditional relative importance (CRI) of attributes of topical treatments for MM AD among adult and adolescent patients and caregivers of children with MM AD.Materials and methods: A discrete-choice experiment (DCE) survey was administered to US adults and adolescents with MM AD and caregivers of children with MM AD. Each choice task comprised 2 hypothetical topical treatments characterized by efficacy, adverse events, vehicle, and application frequency. Data were analyzed using a random-parameters logit model to calculate the CRI of each attribute.Results and conclusions: 300 adults, 331 adolescents, and 330 caregivers completed the DCE. Avoiding changes in skin color (CRI 29.0) and time until itch improves (26.6) were most important to adults, followed by time until clear/almost clear skin (17.8). Application frequency (3.0) did not have a statistically significant impact on adults' choices. Adolescents were less concerned about changes in skin color than adults or caregivers; caregivers were less concerned about time until clear/almost clear skin than patients. Physicians should consider age-relevant aspects of preferences in treatment discussions with patients and caregivers.

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.

Efficacy and Safety of Tazarotene 0.045% Lotion in Caucasian Adults With Moderate-to-Severe Acne.

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.

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.

SUPPLEMENT ARTICLE: Scientific and Clinical Insights into the Facial Application of Mineralizing Volcanic Water.

BACKGROUND: The term "exposome" describes the totality of exposures an individual is subjected to from conception to death. Both internal and external exposome factors affect skin health. External exposures that contribute to facial skin aging include solar radiation, air pollution, tobacco smoke, and unbalanced nutrition. The review explores scientific and clinical insights into the exposome impact on facial skin aging and topical mineralizing volcanic water use potential benefits. METHODS: An expert panel of seven dermatologists and two clinical researchers specializing in aesthetic and dermatological indications reviewed and discussed the literature on the exposome and mineralizing volcanic water's role in relation to the exposome. Two virtual advisory boards were conducted between February and May 2021. Following the meetings, an additional systematic literature review explored publications relevant to the exposome, topical essential minerals, and skin health. The results of the two advisory boards, coupled with expert opinion and the outcome of the updated systematic literature review, informed the statements on which the advisors reached a consensus. CONCLUSIONS: A combination of in vivo, in vitro, and clinical data on topical mineralizing volcanic water application indicates that the serum supports the skin's antioxidant defenses and reduces skin inflammation. Additionally, the serum may have benefits as an adjunct for facial dermatoses and post-procedural skincare. J Drugs Dermatol. 2022;21:4(Suppl 1):s3-10.

Patient and caregiver preferences on treatment attributes for atopic dermatitis.

BACKGROUND: The expanding number of potential treatment options for atopic dermatitis (AD) highlights the need to better understand the treatment preferences of individuals with AD. OBJECTIVE: This study identified attributes that most greatly influenced treatment preferences of adults/adolescents/caregivers of children with mild/moderate/severe AD. METHODS: Adults (≥18 years), adolescents (12-17 years), and caregivers of children (2-11 years) with mild, moderate, or severe AD in the United States (US) and United Kingdom (UK) participated in semistructured interviews. Thematic analysis was used to identify and generate themes across the interview results describing the treatment attributes of greatest importance to participants. RESULTS: Qualitative interviews were conducted with 35 adults, 35 caregivers, and 33 adolescent participants across both countries (n = 103; US = 51; UK = 52) and all severity groups (mild = 43; moderate = 47; severe = 13). The most important treatment attributes included efficacy (96.1%; speed and duration of symptom relief), mode of administration (66.0%; route of administration, frequency, and convenience), and side effects (55.3%, short-term, long-term, and general). CONCLUSIONS: Efficacy, mode of administration, and side effects were the most important attributes that influenced AD treatment preferences for patients and caregivers across different countries, ages, and disease severity. These results may assist patients/caregivers/clinicians in shared decision-making discussions to improve treatment adherence and outcomes.

Management of Truncal Acne With Oral Sarecycline: Pooled Results from Two Phase-3 Clinical Trials.

BACKGROUND: Acne vulgaris is a common skin disease that affects the face, chest, and back. While truncal acne is present in at least 50% of patients, clinical studies have focused predominantly on facial acne.1,2 Few treatments to date have been evaluated for truncal acne. Sarecycline is a narrow-spectrum, third-generation, tetracycline-class oral drug approved for the treatment of acne. Pivotal phase-3 studies show that sarecycline is safe, well-tolerated, and effective treatment for moderate to severe acne vulgaris. METHOD: Pooled analysis was performed for truncal acne results with sarecycline from the two phase 3 studies. Investigator Global Assessment (IGA) success was evaluated at weeks 3, 6, 9, and 12. RESULTS: Chest IGA success rate were significantly greater with sarecycline versus placebo at weeks 3 (11.84% vs 7.71%, respectively; P=0.0192), 6 (18.81% vs 14.03%, respectively; P=0.0390), and 12 (33.42% vs 20.77%, respectively; P<0.0001). Back IGA success rate was also significantly greater with sarecycline versus placebo group at weeks 3 (12.13% vs 7.04%, respectively; P=0.0023), 6 (18.42% vs 14.34%, respectively; P=0.0412), 9 (29.05% vs 19.88%, respectively; P=0.0004) and 12 (33.07% vs 21.91%, respectively; P<0.0001)Conclusion: Sarecycline efficacy for truncal acne was observed within 3 weeks after treatment, supporting sarecycline as an optimal choice for oral treatment of moderate to severe truncal acne. J Drugs Dermatol. 2021;20(6):634-640. doi:10.36849/JDD.6204.

Clinical Evaluation of a Nature-Based Bakuchiol Anti-Aging Moisturizer for Sensitive Skin.

BACKGROUND: Patients with sensitive skin find topical retinoid use for anti-aging purposes challenging due to irritation. Bakuchiol, a meroterpene from the Psoralea corylifolia seed, has retinol functionality through retinol-like regulation of gene expression. OBJECTIVE: This research examined the tolerability, efficacy, and barrier effects of a nature-based bakuchiol-containing cleanser and moisturizer in subjects with sensitive skin. METHODS: 60 female subjects Fitzpatrick skin types I–V age 40–65 years with sensitive mild to moderate photodamaged skin were enrolled in this 4 week study. A sensitive skin panel was constructed: 1/3 eczema/atopic dermatitis, 1/3 rosacea, 1/3 cosmetic intolerance syndrome. Subjects used a nature-based cleanser and moisturizer twice daily and underwent transepidermal water loss (TEWL), corneometry, tolerability assessments, and efficacy assessments at baseline, 5–10 minutes post-application, and week 4. RESULTS: The skin care products were well tolerated and efficacious (P<0.001) in terms of investigator assessed improvement in visual smoothness, tactile smoothness, clarity, radiance, overall appearance, and global anti-aging. Cheek corneometry measurements demonstrated a statistically significant 16% increase in skin moisture content (P<0.001). CONCLUSION: A bakuchiol nature-based anti-aging moisturizer is well tolerated and effective in individuals with sensitive skin.J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5522.

Atopic Dermatitis and the Role of the Skin Microbiome in Choosing Prevention, Treatment, and Maintenance Options.

BACKGROUND: Atopic dermatitis (AD) is a common skin condition characterized by disturbed barrier function, skin inflammation, and cutaneous dysbiosis. Clinically, it manifests as chronic-recurrent xerosis, pruritus, and erythematous lesions. Its pathophysiology is complex, making the selection of appropriate treatment options a task. AIM: To share insights gained from a literature review and discussions with experts in dermatology on key factors related to the prevention, treatment, and management of AD in relation to the skin microbiome. METHODS: Results from an expert panel were summarized and discussed to provide updated recommendations for the treatment and maintenance of AD. RESULTS: Evidence supports a strategy for managing inflammatory skin diseases with a selenium-rich post-biotic thermal water and biomass containing moisturizer. The moisturizer helps to restore homeostasis of the skin, re-populate a diverse microbiome, encourage the growth of commensal bacteria, and improve barrier function and symptoms of AD. CONCLUSIONS: Normalization of skin microbiome diversity using a topical moisturizer containing post-biotic aqua and biomass may offer a valuable option for the treatment and maintenance of inflammatory skin diseases. Clinicians should discuss the benefits of this treatment in the context of a full AD management program that covers prevention, active treatment, and maintenance. J Drugs Dermatol. 2020;19(10):935-940. doi:10.36849/JDD.2020.5393.

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.

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.

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.

The Clinical Relevance and Therapeutic Benefit of Established Active Ingredients Incorporated into Advanced Foam Vehicles: Vehicle Characteristics Can Influence and Improve Patient Outcomes

Topical delivery of therapeutic agents for skin diseases is a major advantage in dermatology. However, the efficacy and tolerability of topically applied therapies is dependent on several characteristics, including percutaneous penetration and permeation of active ingredient and lack of side effects, especially local tolerability reactions. Importantly, the ultimate performance of a topical product includes collectively the effects of the active ingredient and the impact that specific additives have on vehicle characteristics, such as penetration, permeation, epidermal barrier properties, relative irritancy, allergenicity potential, and patient acceptance/preference of the vehicle formulation used. Foam vehicles have evolved over time with the emergence of a menu of alcohol-based and aqueous-based variations that provide various advantages depending on clinical circumstances and the disease being treated. Aqueous-based foams have gained widespread acceptance and preference, especially due to favorable skin tolerability and the cosmetic elegance of the products. In this manuscript, data are presented supporting the efficacy, tolerability, and safety, of specific aqueous-based foam vehicles for calcipotriene used to treat plaque psoriasis, and for tazarotene used to treat acne vulgaris. Discussions include both vehicle-based properties that are relevant to clinical practice, and outcomes from the large-scale pivotal clinical trials that review efficacy and safety results and patient reported outcomes. The latter also discusses several practical subject assessments about use of the foam vehicle. J Drugs Dermatol. 2019;18(2 Suppl):s100-107.

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.

From Probiotic to Prebiotic Using Thermal Spring Water.

BACKGROUND: La Roche-Posay Thermal Spring Water (LRP-TSW) exhibits both probiotic and prebiotic properties enhancing the diversity of the skin microbiota. METHODS: A review was undertaken to explore the role of LRP-TSW as a topical probiotic and prebiotic therapy in improving the diversity of the skin microbiota and reducing dryness and pruritus in inflammatory skin diseases. RESULTS: The concentration of minerals and non-pathogenic microbes in LRP-TSW may explain its therapeutic benefit when used for inflammatory skin diseases. Clinical studies have shown that topical LRP-TSW treatment results in increases in Gram-negative bacteria with reduction of Gram-positive bacteria, and improvements in skin microbial diversity. At the same time skin condition in atopic dermatitis, psoriasis, and general dryness in otherwise healthy skin, has been shown to improve. CONCLUSIONS: Enhancement of skin microbiota diversity using topical LRP-TSW may offer a valuable option for the treatment and maintenance of inflammatory skin diseases. J Drugs Dermatol. 2018;17(6):657-662.

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