Nd:YAG/Er:YAG dual laser compared with topical steroid to treat vulvar lichen sclerosus: A randomised controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of a novel non-ablative Nd:YAG/Er:YAG dual laser treatment for vulvar lichen sclerosus (LS) in comparison with the recommended first-line therapy with topical steroid. DESIGN: A randomised investigator-initiated active-controlled trial. SETTING: Single tertiary referral centre. POPULATION: Women with vulvar LS. METHODS: Randomisation (2:1) to Nd:YAG/Er:YAG laser therapy or topical clobetasol proprionate therapy. Four laser treatments at 0, 1, 2 and 4 months or decreasing doses of steroid for 6 months. MAIN OUTCOME MEASURES: The primary outcome was the change in objective validated clinical LS score in the laser arm between baseline and 6 months. Secondary outcomes were laser tolerability/safety, symptom scores and patient satisfaction. RESULTS: Sixty-six women were included, 44 in the laser group and 22 in the steroid group. The total LS score decreased by -2.34 ± 1.20 (95% CI -2.71 to -1.98) in women treated with laser compared with a decrease of -0.95 ± 0.90 (95% CI -1.35 to -0.56) in those receiving steroid applications (p < 0.001). Laser treatment was safe and well tolerated. Subjective severity scores (on visual analogue scale) and vulvovaginal symptoms questionnaire scores improved similarly for the laser and steroid arms without significant differences between the two treatments. Patient satisfaction was higher in the laser arm than in the steroid arm (p = 0.035). CONCLUSIONS: Non-ablative dual Nd:YAG/Er:YAG laser therapy was safe and significantly improved clinical outcome and subjective symptoms at the 6-month follow up. This suggests that laser may be a promising alternative to corticosteroid therapy. However, the authors caution regular follow ups because of the premalignant nature of the disease.

Halobetasol Propionate 0.01% and Tazarotene 0.045% Lotion With a Ceramide-Containing Moisturizer in Adults With Psoriasis.

INTRODUCTION: Moisturizers are often used as adjuvant therapy for psoriasis to assist with rehydration and skin barrier restoration. Fixed-combination halobetasol propionate 0.01% and tazarotene 0.045% lotion (HP/TAZ) is indicated for the topical treatment of plaque psoriasis in adults, with a demonstrated clinical profile in two phase 3 trials. However, the effect of application order with HP/TAZ has yet to be explored. This study evaluated the clinical profile of HP/TAZ applied before versus after a ceramide-containing moisturizer in adults with mild-to-moderate plaque psoriasis. METHODS: Sixteen participants were randomized to apply HP/TAZ followed by moisturizer on one side and moisturizer followed by HP/TAZ on the other side once daily for 12 weeks. Tolerability, safety, efficacy, and quality of life endpoints were assessed.  Results: Significant Investigator's Global Assessment improvement was observed across all time points (P≤0.003) regardless of application order. Total Dermatology Life Quality Index scores significantly improved at all time points (P≤0.003), and visual analog scale for itch significantly improved at weeks 4, 8, and 12 (P<0.008). Four moderate adverse events were experienced by 3 participants. Two participants reported itching/irritation, which was worse when HP/TAZ was applied first. CONCLUSIONS: The application order of moisturizer did not decrease therapeutic efficacy of HP/TAZ. Moisturizer application before HP/TAZ may reduce incidence of application site adverse events, ultimately increasing tolerability and supporting the real-world recommendation that applying a ceramide-containing moisturizer before HP/TAZ, versus after, results in a safe and effective therapeutic option for plaque psoriasis. J Drugs Dermatol. 2024;23(2):50-53.     doi:10.36849/JDD.7928.

[Clinical and pathological analysis of 345 cases of vulvar lichen sclerosus and a preliminary study on the frequency of maintenance treatment].

Objective: To analyze and summarize the clinical and pathological characteristics, management, and efficacy of patients with vulvar lichen sclerosus (VLS) through a single center large sample study, and preliminarily to explore the frequency of maintenance treatment medication for VLS. Methods: The clinical data of VLS patients in Obstetrics and Gynecology Hospital of Fudan University from 2018 to 2021 were retrospectively collected. The clinicopathological characteristics (patients' age, course of disease, complicated disease history, family history, symptoms, signs and pathology), treatment and effects were retrospectively analyzed. The patients in the maintenance treatment stage were followed up regularly to explore the minimum frequency of individual medication to maintain the stability of the disease. Results: (1) General situation: a total of 345 patients with VLS were included in this study. The average age was (50.4±14.7) years (ranged from 8 to 84 years old), prevalence was highest in the 50-59 years group (30.1%, 104/345). Immune diseases occurred in 18.6% (33/177) of patients, 24.3% (43/177) of patients had allergic skin diseases, and 5.6% (10/177) of the patients' immediate family members had chronic vulvar pruritus or vulvar hypopigmentation. (2) Clinical features: the most common symptom was vulvar pruritus (96.1%, 196/204) among 204 patients with recorded symptoms. The most common sign was hypopigmentation of the vulva (96.3%, 206/214). The most common involved sites were labia minora (70.3%, 142/202), labia majora (67.8%, 137/202), and labial sulcus (59.4%, 120/202). The cumulative number of sites involved in 62 vulvar atrophy patients (2.7±1.1) was significantly higher than that in 152 non-atrophy patients (2.2±1.0; t=3.48, P=0.001). The course of vulvar atrophy was (9.3±8.5) years, which was significantly longer than that of non-atrophy patients [(6.6±5.6) years; t=2.04, P=0.046]. (3) Pathological features: among the 286 patients with electronic pathological sections, the most common pathological feature in the epidermis was epithelial nail process passivation (71.3%, 204/286). The common pathological features in the dermis were interstitial collagenization (84.6%, 242/286), and inflammatory cell infiltration (73.8%, 211/286). (4) Treatment: 177 patients received standardized treatment after diagnosis and were followed up regularly in our hospital. In the initial treatment stage, 26.0% (46/177) of the patients were treated with 0.05% clobetasol propionate cream, and 74.0% (131/177) of the patients were treated with 0.1% mometasone furoate ointment. The complete remission rates of the two methods were respectively 80.4% (37/46) and 74.0% (97/131), and there was no statistically significant difference (χ²=0.76, P=0.385). During maintenance treatment, 27.1% (48/177) of the patients took the medication twice a week, 35.0% (62/177) took the medication once a week, and 37.9% (67/177) took the medication once every 10 days. During follow-up after 6 months of maintenance treatment, there were no patients with recurrence of pruritus or progression of vulvar signs. Conclusions: The majority of VLS patients have itching, hypopigmentation, involvement of labia minora and labia majora, progressive atrophy, and inflammatory infiltration of dermis. Local treatments of mometasone furoate and clobetasol propionate have good initial therapeutic effects. The frequency exploration of individualized maintenance treatment could minimize the occurrence of adverse reactions when ensuring the stability of the patients' condition.

Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial.

BACKGROUND: Oral lichen planus (OLP) is a chronic inflammatory disorder of the oral mucosa. Currently there is no approved treatment for OLP. We report on the efficacy and safety of a novel mucoadhesive clobetasol patch (Rivelin® -CLO) for the treatment of OLP. METHODS: Patients with confirmed OLP and measurable symptomatic ulcer(s) participated in a randomized, double-blind, placebo-controlled, multicenter clinical trial testing a novel mucoadhesive clobetasol patch (Rivelin® -CLO) in OLP across Europe, Canada, and the United States. Patients were randomized to placebo (nonmedicated), 1, 5, 20 µg Clobetasol/patch, twice daily, for 4 weeks. The primary endpoint was change in total ulcer area compared to baseline. Secondary endpoints included improvement from baseline in pain, disease activity, and quality of life. RESULTS: Data were analyzed and expressed as mean [SD]. One hundred thirty-eight patients were included in the study; 99 females and 39 males, mean age was 61.1 [11.6] years. Statistical analyses revealed that treatment with 20-µg Rivelin® -CLO patches demonstrated significant improvement with ulcer area (p = 0.047), symptom severity (p = 0.001), disease activity (p = 0.022), pain (p = 0.012), and quality of life (p = 0.003) as compared with placebo. Improvement in OLP symptoms from beginning to the end of the study was reported as very much better (best rating) in the 20-µg group (25/32) patients compared to the placebo group (11/30), (p = 0.012). Adverse events were mild/moderate. Candidiasis incidence was low (2%). CONCLUSIONS: Rivelin® -CLO patches were superior to placebo demonstrating statistically significant, clinically relevant efficacy in objective and subjective improvement and, with a favorable safety profile.

Efficacy of topical administration for oral lichen planus: A network meta-analysis.

OBJECTIVE: To examine the comparative efficacy and safety of topical administration for oral lichen planus. MATERIALS AND METHODS: An electronic database search (1st January 1946 to 1st May 2020) for randomised controlled trials identified 34 studies involving eight interventions (clobetasol, betamethasone, triamcinolone, dexamethasone, fluocinolone, tacrolimus, pimecrolimus, and cyclosporine); these studies were subjected to network meta-analysis using direct and indirect comparisons [efficacy indicators: clinical response rate, symptom-reducing effect (visual analogue scale score), sign-reducing effect (Thongprasom-scale score) and relapse; safety indicator: adverse event occurrence]. RESULTS: Compared with placebo, tacrolimus had the best clinical response rate (odds ratio (OR), 57.78 [95% CI 3.15-1060.52]; P-score, 0.8654) and cyclosporine had the worst (OR, 3.61[95% CI 0.20-66.62]; P-score, 0.2236); tacrolimus had the best symptom-reducing effect (standardised mean difference (SMD), 1.06 [95% CI 0.41-1.71]; P-score, 0.9323) and fluocinolone had the worst (SMD, -0.54 [95% CI -1.44-0.36]; P-score, 0.0157); dexamethasone had the best sign-reducing effect (SMD, 3.60 [95% CI 1.74-5.45]; P-score, 0.8306) and clobetasol had the worst (SMD, 2.63 [95% CI 1.66-3.61]; P-score, 0.2581); and pimecrolimus performed best (OR, 0.04 [95% CI 0.00-0.64]; P-score, 0.9227) and clobetasol performed the worst [OR, 0.60; 95% CI 0.15-2.45; P-score, 0.2545] in reducing relapse. Regarding safety, dexamethasone was the safest compared with placebo [OR, 0.37; 95% CI 0.05-2.57; P-score, 0.9337), whereas fluocinolone ranked low for safety [OR, 9.48; 95% CI 1.50- 60.03; P-score, 0.1189]. CONCLUSIONS: The relative ranking of topical administration varies according to the different indicators. Based on the joint consideration of clinical response rate and adverse event occurrence, dexamethasone, triamcinolone and betamethasone are recommended for better efficacy and safety. The optimal treatment for oral lichen patients varies under different conditions.

The Effect of Lipofilling and Platelet-Rich Plasma on Patients with Moderate-Severe Vulvar Lichen Sclerosus who were Non-Responders to Topical Clobetasol Propionate: A Randomized Pilot Study.

BACKGROUND: The first-line treatment for vulvar lichen sclerosus (VLS) is 3 months of topical corticosteroid therapy. However, limited evidence is available concerning the use of fat grafting and platelet-rich plasma as a second-line treatment for patients who do not respond to first-line treatment. METHODS: This prospective single-center randomized pilot trial included 20 patients with a clinical and histological diagnosis of moderate to severe VLS. The patients in the treatment group (TG) received two infiltrations (at 3-month intervals) of nanofat mixed with platelet-rich plasma (PRP) into the vulvar area, while the control group (CG) received standard topical corticosteroid therapy. Fat was aspirated from the medial thigh or lower abdomen regions. Microfat was obtained after centrifugation and was emulsified to obtain a nanofat suspension. Treatment efficacy was determined by measuring changes in the vulvar skin elasticity, histopathology, and clinical signs, symptoms, and patient quality of life at after 1 year. RESULTS: A total of 19 patients were finally assessed (9 TG and 10 CG). At the end of the study (1 year), there had been no significant improvement in vulvar skin elasticity. However, patients in the TG showed a significant improvement in their symptoms (itching, pain, burning, and dyspareunia) and clinical signs (cervical erosions, fissures, stenosis, and leukoderma). Analysis of skin biopsies revealed a significant decrease in all inflammatory cell types in the TG. No adverse events related to the autologous treatment were recorded. CONCLUSIONS: Compared with topical corticosteroids, two infiltrations delivered 3 months apart decreased the inflammation of the vulva and improved most of the clinical signs and symptoms associated with VLS. Nonetheless, no improvement in vulvar skin elasticity was derived from the autologous treatment. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Efficacy of the combined excimer light and topical calcipotriol for acral vitiligo: A randomized double-blind comparative study.

Excimer light, topical vitamin D analogues, and topical steroids have been reported to be effective treatments for vitiligo. However, monotherapy often demonstrates unfavorable results for acral vitiligo. This study aimed to evaluate the efficacy and safety of combination treatment with 308-nm excimer light and topical calcipotriol or topical clobetasol ointment for acral vitiligo. A prospective, randomized, double-blind, and intraindividual study was conducted. Combination treatment (excimer light and topical medication) was applied in the first 12 weeks, and monotherapy (topical medication alone) was used in the later 12 weeks. Both hands were irradiated with excimer light three times a week for 12 weeks. Calcipotriol ointment was randomly assigned to one hand, whereas clobetasol ointment was assigned to the other hand. The ointments were applied twice daily for a total of 24 weeks. Repigmentation, clinical improvement, and adverse reactions were assessed. A total of 26 hands completed the study. Of the hands treated with excimer light and calcipotriol, approximately 8% achieved excellent repigmentation at the end of the combination treatment period and 23% achieved good to excellent improvement after 12 weeks of calcipotriol monotherapy. More than 85% and 77% of the hands treated with calcipotriol-based and clobetasol-based regimens showed some repigmentation at the end of the study, respectively (P < .05). Nevertheless, no significant difference was found between the treatments. No serious adverse reactions were observed. In conclusion, the combination of excimer light and topical calcipotriol followed by topical calcipotriol alone is effective and might be a promising treatment regimen for acral vitiligo.

An Open-Label Pilot Study to Investigate Safety and Efficacy of Fixed Combination Tazarotene 0.045% and Halobetasol Propionate 0.01% Lotion for the Treatment of Scalp Psoriasis.

Up to 80% of individuals with plaque psoriasis have scalp involvement, which can have a significant impact on the quality of life of affected individuals. Despite advancements in psoriasis therapeutics, management of scalp involvement remains a challenge. This12-week, open-label pilot study assessed the safety and efficacy of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion for the treatment of patients with mild-to-moderate plaque psoriasis with scalp involvement. Among 20 patients who were followed through 12 weeks, there were significant improvements in the primary endpoint (Investigator’s Global Assessment (IGA)) and most secondary endpoints (Psoriasis Scalp Severity Index (PSSI), body surface area (BSA), and scalp IGA (sIGA)). Treatment was well-tolerated. Further placebo-controlled double-blinded study for confirmation of our results is recommended. J Drugs Dermatol. 2021;20(11): 1191-1194. doi:10.36849/JDD.0102.

Once-Daily Halobetasol Propionate 0.01% Lotion for Moderate-to-Severe Plaque Psoriasis: Phase 3 Analysis of Hispanic Participants.

BACKGROUND: Psoriasis is a chronic, inflammatory disease that may differ in prevalence and clinical presentation among patients from various racial and ethnic groups. Two phase 3 studies demonstrated efficacy and safety of halobetasol propionate (HP) 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis (NCT02514577, NCT02515097). These post hoc analyses evaluated HP 0.01% lotion in Hispanic participants. METHODS: Participants were randomized (2:1) to receive once-daily HP or vehicle lotion for 8 weeks, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in Hispanic participants (HP, n=76; vehicle, n=43) included treatment success (≥2­grade improvement in Investigator’s Global Assessment and score of ‘clear’ or ‘almost clear’), psoriasis signs, and affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. RESULTS: At week 8, 38.8% of participants achieved treatment success with HP versus 10.3% on vehicle (P=0.001). HP­treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P<0.01 all). HP group had a greater reduction in affected BSA versus vehicle (P=0.001). Treatment-related TEAEs with HP were application site infection and dermatitis (n=1 each). CONCLUSIONS: Once-daily HP 0.01% lotion was associated with significant reductions in disease severity in Hispanic participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks. J Drugs Dermatol. 2021;20(3):252-258. doi:10.36849/JDD.5698.

Clobetasol propionate 0.05% under occlusion for alopecia areata: Clinical effect and influence on intraocular pressure.

Topical corticosteroids are known to be effective in the treatment of alopecia areata, but the potential effects on intraocular pressure are a concern. The purpose of this retrospective study is to evaluate the effect of clobetasol propionate 0.05% under occlusion on patients with active phase alopecia areata and to examine the effects on intraocular pressure. We also wished to see if reducing the frequency of application of clobetasol increased the safety with respect to intraocular pressure. Elevation of intraocular pressure due to topical corticosteroids is unlikely to occur at the dose of 9.8 g or less per week used in this study; however, ophthalmologic examination at the start of treatment was thought to be worthwhile in identifying patients with latent glaucoma.

Topical Applications of a Heparinoid-Containing Product Attenuate Glucocorticoid-Induced Alterations in Epidermal Permeability Barrier in Mice.

INTRODUCTION: Either systemic or topical glucocorticoids (GCs) can cause significant adverse effects on cutaneous structure and function. Although some products and ingredients can improve GC-induced abnormalities in epidermal permeability barrier, the efficacy is moderate. Prior studies in normal mice showed that topical applications of a heparinoid-containing product, Hirudoid® cream, improve epidermal barrier function by upregulation of epidermal proliferation, expression of mRNA for epidermal differentiation, and lipid production. OBJECTIVE: The objective of this study was to assess whether topical applications of this product could prevent GC-induced changes in epidermal function in murine skin. MATERIALS AND METHODS: One group of C57BL/6J mice was treated topically with 0.05% clobetasol propionate twice daily for 6 days, while another group was treated topically with Hirudoid® cream 30 min after each application of clobetasol propionate. Untreated mice served as normal controls. Transepidermal water loss (TEWL) rates, stratum corneum hydration, and skin surface pH were measured using respective probes connected to an MPA5 physiology monitor. qPCR was used to measure the expression levels of mRNA for keratinocyte differentiation-related proteins and lipid synthetic enzymes. RESULTS: Co-applications of Hirudoid® cream with GC minimally, but significantly, increased skin thickness in comparison to GC treatment alone (p < 0.05), in parallel with increased expression levels of mRNA for PCNA in both the dermis and the epidermis. Moreover, Hirudoid® cream largely prevented GC-induced elevation in basal TEWL (p < 0.001) and delay in barrier recovery (p < 0.05), accompanied by upregulation in the expression levels of mRNA for epidermal involucrin, HMGCoA, and SPT1. However, both stratum corneum hydration and skin surface pH were comparable in the skin treated with GC alone versus GC + Hirudoid® cream. CONCLUSION: Topical heparinoid-containing product can partially prevent GC-induced alterations in some epidermal functions.

Treating Psoriasis With Halobetasol Propionate and Tazarotene Combination: A Review of Phase II and III Clinical Trials.

Objective: To review phase II and III clinical trial data to evaluate the efficacy and safety of the halobetasol propionate/tazarotene (HP/TAZ) combination lotion (Duobrii), a medication approved by the Food and Drug Administration in April 2019 for adults with plaque psoriasis. Data Sources: A systematic search (January 2005 to July 2019) of MEDLINE (PubMed) and EMBASE databases was performed using the terms halobetasol, tazarotene, halobetasol/tazarotene, Duobrii, and IDP-118. Study Selection and Data Extraction: Relevant English-language articles reporting on phase II and phase III clinical trials were included. Data from the individual trials were extracted independently and then cross-checked to ensure accuracy. Data Synthesis: HP/TAZ was safe and efficacious compared with HP alone, TAZ alone, or vehicle. More patients achieved treatment success, described as a ≥2-grade improvement on Investigator Global Assessment Scale, over 8 weeks of treatment and at the 4-week follow-up after treatment cessation. The most common adverse events were dermatitis, pain, and pruritus, which occurred more often in the TAZ groups compared with the HP/TAZ cohorts. Relevance to Patient Care and Clinical Practice: The once-daily HP/TAZ combination lotion simplifies psoriasis treatment and may facilitate adherence, which may improve psoriasis outcomes. Conclusions: HP/TAZ combination lotion is efficacious and safe for plaque psoriasis treatment, with more patients achieving end points and fewer side effects than in HP, TAZ, or vehicle-treated controls. Drug synergy may play a role. Importantly, patient adherence to a once-daily combinational therapy is likely to contribute to efficacy.

Comparative evaluation of Gracilaria algae 3% cream vs Clobetasol 0.05% cream in treatment of plaque type psoriasis: A randomized, split-body, triple-blinded clinical trial.

Gracilaria algae is red macro algae which has demonstrated considerable anti-inflammatory effects. Our objective was to compare the efficacy of Gracilaria algae topical cream 3% vs Clobetasol cream 0.05% in treatment of plaque-type psoriasis. Thirty adult patients with baseline modified Psoriasis Area and Severity Index (PASI) score ≤12 were randomized to receive either Clobetasol or Gracilaria algae cream on right or left-sided symmetric plaques once daily for 8 weeks and follow-up of 4 weeks. Modified PASI score, patient's satisfaction using VAS and global physician assessment score were assessed to evaluate clinical response. Thirty patients with 94 symmetrical psoriasis plaques were enrolled in this trial. The mean baseline modified PASI score of both sides was similar; however, at the end of trial, modified PASI score was reduced more on the sides treated with Gracilaria algae cream (0.80 ± 0.19% vs 0.63 ± 0.25%, P < .05). No significant difference was found regarding mean physician global assessment score between the two groups (P > .05). Patients' satisfaction was significantly higher in favor of algae cream only at week 8 of the intervention (P < .05). Gracilaria algae cream can be an effective and safe alternative of Clobetasol in the treatment of plaque type psoriasis.

Halobetasol Propionate Lotion 0.01% for Moderate-to-Severe Plaque Psoriasis: Pooled Analysis in Male and Female Participants.

Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups. Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2­grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8. Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250.

Halobetasol 0.01%/Tazarotene 0.045% Lotion for Moderate-to-Severe Psoriasis: Pooled Phase 3 Analysis of Males and Females.

BACKGROUND: Previous results from two phase 3 studies demonstrated efficacy and safety of fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in participants with moderate-to-severe plaque psoriasis. This post hoc analysis evaluated sex-specific efficacy and safety of HP/TAZ lotion. METHODS: In two randomized, double-blind, phase 3 studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Male and female participants were evaluated separately in this pooled analysis. Efficacy assessments included treatment success (at least 2­grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA). RESULTS: The analysis included 272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle in both male (38.4% vs 9.8%) and female (44.5% vs 9.9%) subgroups (P<0.001, both). Erythema, plaque elevation, and scaling were also reduced by week 8 in both males and females, with significantly more HP/TAZ-treated participants achieving at least 2­grade improvement in each sign of psoriasis than vehicle-treated participants (P<0.001 each, both groups). Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both). The most frequent treatment-related adverse events were contact dermatitis, pruritis, and application site pain (each 4.0%) in females and contact dermatitis (7.6%) in males. CONCLUSION: HP/TAZ lotion was highly effective and safe in both males and females with moderate-to-severe psoriasis over 8 weeks of once-daily use. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.5021.

Iatrogenic hypercortisolism in a Persian kitten after topical application of a skin lotion containing clobetasol.

Hypercortisolism is a rare endocrine disorder in cats. This report describes the clinicopathological findings and successful management of iatrogenic hypercortisolism in a Persian kitten. The disorder was presumed to be a consequence of prolonged topical application of a lotion containing clobetasol.

L'hypercortisolisme est une maladie endocrine rare chez le chat. Cet article décrit les données clinicopathologiques et la gestion efficace d'hypercortisolisme iatrogénique chez un chaton persan. La maladie a été présumée être la conséquence d'application prolongée topique d'une lotion contenant du clobétasol.

El hipercortisolismo es un trastorno endocrino poco común en gatos. Este artículo describe los hallazgos clínico-patológicos y el manejo exitoso de hipercortisolismo iatrogénico en un gatito persa. Se presume que el trastorno fue consecuencia de la aplicación tópica prolongada de una loción que contenía clobetasol.

O hipercortisolismo é uma doença endócrina rara em gatos. Este relatório descreve os achados clínico-patológicos e o manejo bem-sucedido do hipercortisolismo iatrogênico em um gatinho persa. O distúrbio foi considerado uma consequência da aplicação tópica prolongada de uma loção contendo clobetasol.

Granuloma inframammary adultorum, a case report.

Granuloma inframammary adultorum represents a variant of erosive papulonodular dermatosis; we report a case of a patient with bilateral erosive plaques and nodules predominantly located under the breast.

Halobetasol 0.01%/Tazarotene 0.045% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Maintenance of Therapeutic Effect After Cessation of Therapy

BACKGROUND: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use and recurrence is common. Tazarotene has also been shown to be effective in psoriasis, with efficacy maintained several weeks posttreatment. Fixed combination therapy with TCS and tazarotene may improve psoriasis signs and maintain efficacy between treatment sessions. OBJECTIVE: To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with vehicle in patients with moderate or severe plaque psoriasis. METHODS: Two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe psoriasis (N=418). Patients randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks with a 4 week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and 'clear' or 'almost clear'), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, and maintenance of improvements in Body Surface Area (BSA), IGAxBSA and clinically meaningful benefit (IGAxBSA-75). RESULTS: At week 8, 40.7% of patients achieved treatment success with HP/TAZ lotion, compared with 9.9% treated with vehicle (P<0.001). Four weeks posttreatment, 33.3% of patients achieved treatment success. Two thirds of patients (63%) who were treatment successes at week 8 remained treatment successes posttreatment. In addition, up to 20% of patients who were not treatment successes at week 8 became treatment successes by the end of the study. Three-quarters of patients maintained BSA improvements or reported further reductions in BSA that seemed to be unrelated to baseline BSA severity. At the end of the 4 week posttreatment period, patients who had been treated with HP/TAZ lotion achieved a 46.6% reduction in IGAxBSA, compared with 7.9% on vehicle. 41.7% of patients achieved a clinically meaningful effect at week 8 and this was maintained posttreatment. LIMITATIONS: The studies only had a 4 week follow-up period. CONCLUSIONS: In conclusion, HP 0.01%/TAZ 0.045% lotion provides effective maintenance of efficacy over a 4 week posttreatment period.

Halobetasol 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis of the Lower Extremities

Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. Recently data were reported on the use of halobetasol propionate (HP) 0.01% lotion in moderate or severe localized plaque psoriasis, once-daily for 8 weeks. In addition, a 2-week label-restricted study reported comparable efficacy to HP 0.05% cream. Data evaluating efficacy in specific locations has not been reported and while psoriasis commonly affects lower extremities treatment can be more problematic and burden of disease heightened. Objective: To investigate the efficacy of a once-daily application of HP 0.01% lotion in comparison with its vehicle in patients with moderate-to-severe plaque psoriasis of the lower extremities. Methods: A post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate or severe psoriasis. Subjects (N=234) where the leg was identified as the target lesion were randomized (2:1 ratio) to receive HP 0.01% lotion or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline) in each individual sign of psoriasis (erythema, plaque elevation, and scaling) at the target lesion (leg) and overall treatment outcomes including at least a 2-grade improvement from baseline in the Investigator Global Assessment (IGA) score, and 'clear' or 'almost clear', improvement in Body Surface Area (BSA) and reduction in IGAxBSA. Quality of Life (QoL) was assessed using the Dermatology Life Quality Index (DLQI) at baseline, week 4, 8, and 12. Results: At the end of the 8-week treatment period, more than half of subjects had achieved treatment success, with 52.1%, 55.5%, and 58.2% of subjects achieving at least a 2-grade reduction in erythema, plaque elevation and scaling severity on the leg, compared with 15.7% and 22.9%, and 22.2% of those treated with vehicle (P<0.001). In addition, overall treatment success (IGA) was achieved in 37.1% of these subjects who had been treated with HP 0.01% lotion compared with 8.4% treated with vehicle (P<0.001); with a corresponding 34.2% reduction in baseline BSA and 50.5% change in mean baseline IGAxBSA (both P<0.001 versus vehicle). Overall, a clinically relevant improvement in QoL was achieved by week 4; by week 8 37.7% of subjects where the leg was the target lesion had a clinically meaningful improvement in disease severity (IGAxBSA-75). Conclusions: In conclusion, halobetasol propionate 0.01% lotion provides statistically significant efficacy following 8 weeks' therapy compared with vehicle in subjects where the leg was identified as the target lesion, with clinically relevant improvements in QoL and more than a third of subjects achieving a clinically meaningful result. J Drugs Dermatol. 2019;18(10):1029-1036.

Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Foam Formulation of Halobetasol Propionate, 0.05% vs Its Vehicle in Adult Subjects With Plaque Psoriasis

BACKGROUND: A novel foam formulation of halobetasol propionate, 0.05% (HBP-Foam) has been developed to treat plaque psoriasis in patients who prefer a thermostable topical foam with low application shear that allows for easier coverage over large and/or hirsute areas than existing formulations. OBJECTIVE: To determine the safety and effectiveness of HBP-Foam in subjects with plaque psoriasis. METHODS: Two randomized, double-blind, vehicle-controlled clinical studies were conducted in 560 adult subjects with moderate to severe plaque psoriasis. Subjects applied the assigned test article to all psoriatic plaques twice daily for 14 days. The key efficacy measures were the proportion of subjects with "treatment success," defined as those subjects that achieved a score of 0 (clear) or 1 (almost clear) and at least a two-grade improvement compared to baseline for the Investigator's Global Assessment (IGA) and for the clinical signs of psoriasis (plaque elevation, scaling, and erythema) as well as pruritus. Safety measurements included adverse events and local skin reactions in the treatment area. RESULTS: HBP-Foam was statistically superior to vehicle in achieving "Treatment Success" in 25.3% and 30.7% vs 3.9% and 7.4% (P<0.001) in Studies 1 and 2, respectively. Pruritus scores statistically improved by over 30% in HBP-Foam treated subjects. In addition, these subjects experienced a significant reduction in the clinical signs of psoriasis (plaque elevation, scaling, and erythema). In contrast, in the vehicle groups the decrease in psoriasis-related signs was generally not observed. Safety outcomes were unremarkable and similar in both the HBP-Foam and vehicle treatment groups. CONCLUSIONS: These results demonstrate the safety and effectiveness of HBP-Foam in the treatment of plaque psoriasis. Furthermore, this novel foam formulation has demonstrable for its ease of application over large and/or hairy treatment areas. ClinicalTrials.gov Registration: NCT02742441 NCT02368210