A randomized phase 3b/4 study to evaluate concomitant use of topical ivermectin 1% cream and doxycycline 40-mg modified-release capsules, versus topical ivermectin 1% cream and placebo in the treatment of severe rosacea.

BACKGROUND: Randomized controlled studies of combination therapies in rosacea are limited. OBJECTIVE: Evaluate the efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (ie, 30-mg immediate-release and 10-mg delayed-release beads) (DMR) versus IVM and placebo for treatment of severe rosacea. METHODS: This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA] score, 4) to receive either IVM and DMR (combination arm) or IVM and placebo (monotherapy). RESULTS: A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs -73.6% for monotherapy [P = .032]) and IGA score (P = .032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving an IGA score of 0 (11.9% vs 5.1% [P = .043]) and 100% lesion reduction (17.8% vs 7.2% [P = .006]) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index score, and ocular signs/symptoms and were well tolerated. LIMITATIONS: The duration of the study prevented evaluation of potential recurrences or further improvements. CONCLUSION: Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in cases of severe rosacea.

Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study

Background: Patients with skin of color (SOC) and Fitzpatrick skin types (FST) IV­VI frequently develop acne. Objective: Evaluate subject-reported outcomes after treatment with adapalene 0.3%/ benzoyl peroxide 2.5% gel (0.3% A/BPO) in subjects with SOC and moderate to severe acne vulgaris. Methods: This was an open-label interventional study conducted in 3 countries (Mauritius, Singapore, and USA) in subjects of Asian, Latin-American, or black/African-American ethnicity, with an Investigator's Global Assessment (IGA) of moderate or severe facial acne (enrollment 2:1), and FST IV to VI. For 16 weeks, subjects applied 0.3% A/BPO (once daily) and utilized a skin care regimen (oil control foam wash and oil control moisturizer SPF30). Assessments included quality of life (QoL) and subject questionnaires, IGA, Investigator's Global Assessment of Improvement (GAI), postinflammatory hyperpigmentation (PIH; if present at baseline), and safety. Results: Fifty subjects were enrolled: 20 Asians, 17 black/African-Americans, and 13 Latin-Americans. Most had FST IV (74%) or V (22%), with moderate (70%; IGA 3) or severe (30%; IGA 4) acne. At week 16, 77% of subjects were satisfied or very satisfied with treatment, 56% of subjects had an IGA of 0 or 1 (clear/almost clear), and 87% had a good to excellent improvement in GAI. QoL improved throughout the study for all subjects; subject selection of "no effect at all" of acne on QoL increased from 16% of subjects at baseline to 55% at week 16. Of those with baseline PIH (60%), all were rated very mild to moderate. By week 16, the majority (75%) had no or very mild PIH, and the mean decrease in PIH was 27%. There were no adverse events leading to study discontinuation. Conclusion: Patients with SOC and moderate or severe facial acne reported high satisfaction with 0.3% A/BPO treatment and experienced good tolerability, improved QoL, treatment efficacy, and improvement in PIH. Clinicaltrials.gov number: NCT02932267 J Drugs Dermatol. 2019;18(6):514-520.

Hyaluronic Acid Filler Injections Under the Metatarsal Heads Provide a Significant and Long-Lasting Improvement in Metatarsalgia From Wearing High-Heeled Shoes.

BACKGROUND: Metatarsalgia is a common overuse injury that may be caused by wearing high-heeled shoes. OBJECTIVE: To evaluate the decrease in metatarsalgia using a hyaluronic acid dermal filler. METHODS: A 6-month, open study was conducted in 15 subjects with metatarsalgia because of regularly wearing high-heeled shoes. Hyaluronic acid (20 mg/mL) with lidocaine hydrochloride (3 mg/mL) was injected under the metatarsal heads at baseline. Pain (on a 0-10 scale) under the metatarsal heads when walking in high heels was recorded in a weekly subject diary. RESULTS: At 6 months after injections, 5 subjects (33.3%) reported no metatarsalgia pain. For subjects with pain, they were able to wear high heels for significantly longer than before the injections (7.2 hours at 6 months vs 3.4 hours at baseline). Significant improvements from baseline were observed at Month 6 for time to onset of pain (3.5 hours longer), time between onset of pain and intolerable pain (1.9 hours longer), and pain sensation (-2.2 grades at onset and -3.8 grades at shoe removal). No adverse events were reported. CONCLUSION: Injection of hyaluronic acid filler to the forefeet provided a significant effective, long-lasting, and well-tolerated improvement in metatarsalgia because of wearing high-heeled shoes.

Treatment of Rosacea With Concomitant Use of Topical Ivermectin 1% Cream and Brimonidine 0.33% Gel: A Randomized, Vehicle-controlled Study.

BACKGROUND: There is currently a lack of data on the simultaneous treatment of different features of rosacea. Individually, ivermectin 1% (IVM) cream and brimonidine 0.33% (BR) gel have demonstrated efficacy on inflammatory lesions and persistent erythema, respectively. OBJECTIVE: To evaluate the efficacy, safety, patient satisfaction, and optimal timing of administration of IVM associated with BR (IVM+BR) versus their vehicles in rosacea (investigator global assessment [IGA] ≥3). METHODS: Multicenter, randomized, double-blind study including subjects with rosacea characterized by moderate to severe persistent erythema and inflammatory lesions. The active treatment group included the IVM+BR/12 weeks subgroup (once-daily BR and once-daily IVM for 12 weeks), and the IVM+BR/8 weeks subgroup (once-daily BR vehicle for 4 weeks followed by once-daily BR for the remaining 8 weeks and once-daily IVM for 12 weeks). The vehicle group received once-daily BR vehicle and once-daily IVM vehicle for 12 weeks. RESULTS: The association showed superior efficacy (IGA success [clear/almost clear]) for erythema and inflammatory lesions in the total active group (combined active subgroups) compared to vehicle (55.8% vs. 36.8%, P=0.007) at week 12. The success rate increased from 32.7% to 61.2% at hour 0 and hour 3, respectively, in the IVM+BR/12 weeks subgroup, and from 28.3% to 50% in the IVM+BR/8 weeks subgroup. Reductions in erythema and inflammatory lesion counts confirmed the additive effect of BR to IVM treatment. Subjects reported greater improvement in the active subgroups than in the vehicle group, and similar rates for facial appearance satisfaction after the first 4 weeks of treatment in both active subgroups. All groups showed similar tolerability profiles. CONCLUSION: Concomitant administration of IVM cream with BR gel demonstrated good efficacy and safety, endorsing the comprehensive approach to this complex disease. Early introduction of BR, along with a complete daily skin care regimen may accelerate treatment success without impairing tolerability.

J Drugs Dermatol. 2017;16(9):909-916.

Development and Evaluation of a Rosacea Screening Instrument (Rosascreen).

BACKGROUND: There are no current instruments to facilitate population screening for rosacea. OBJECTIVE: To develop and evaluate a screening instrument for rosacea applicable for population surveys. METHODS: A rosacea-specific screening instrument (Rosascreen), consisting of a subject-completed questionnaire and screening algorithm, was developed based on current diagnostic criteria for rosacea. Three iterations were pilot tested and refined for clarity and sensitivity in adult outpatients with and without rosacea. RESULTS: Three subject groups were consecutively evaluated with iterations of the questionnaire at each centre (overall N = 121). The final version had a sensitivity of 93% to 100% for key diagnostic criteria, and use of the algorithm had a sensitivity of 100% for detection of rosacea and specificity of 63% to 71%. Most subjects found the questionnaire easy to understand and complete. CONCLUSION: Rosascreen, a subject-completed questionnaire and diagnostic algorithm, is a highly sensitive screening instrument that may facilitate estimation of rosacea prevalence in general populations.

High Patient Satisfaction of a Hyaluronic Acid Filler Producing Enduring Full-Facial Volume Restoration: An 18-Month Open Multicenter Study.

BACKGROUND: Volume restoration is an essential part of facial rejuvenation. OBJECTIVE: To assess long-term full-facial volume restoration using HAEL Volume Lidocaine hyaluronic acid filler. METHODS: An 18-month open study in 60 subjects with at least Grade 2 on the 4-point volume loss scale (VLS) for full face and at least 2 indications affected among chin, temporal areas, jawline, cheeks, cheekbones, and nasolabial folds (NLF). Performance was assessed by VLS, Lemperle rating scale (LRS), investigator Global Aesthetic Improvement Scale (GAIS), and 3-dimensional (3D) imaging. RESULTS: Most subjects (71.6%) had 3 or 4 indications injected, most commonly cheekbones (96.7%) and NLF (93.3%). At 18 months, at least a 1-grade improvement in VLS was observed for full face (68.3% of subjects), chin (77.8%), temporal areas (73.7%), cheeks (66.6%), cheekbones (58.6%), jawline (43.1%), and NLF (71.4%; LRS). For all indications, more than 60% of the volume gained at 3 weeks was sustained at 18 months based on 3D digital imaging. At 18 months, 95.0% of subjects had improved full-face GAIS and all subjects were satisfied with their aesthetic outcome. One subject (1.6%) had treatment-related adverse events. CONCLUSION: Full-facial volume restoration was well sustained over 18 months with high patient satisfaction and good tolerability.

Patient Satisfaction and Efficacy of Full-Facial Rejuvenation Using a Combination of Botulinum Toxin Type A and Hyaluronic Acid Filler.

BACKGROUND: Combination treatments using hyaluronic acid (HA) fillers and botulinum toxin Type A (BoNT-A) are common in aesthetic medicine; however, this has been evaluated in only a few clinical studies. OBJECTIVE: To evaluate subject satisfaction, efficacy, and safety of BoNT-A (Speywood Unit; s.U) and a range of HA fillers for full-facial aesthetic rejuvenation. MATERIALS AND METHODS: A 6-month, multicenter, open-label clinical study, using BoNT-A (s.U) and 5 HA fillers to treat up to 13 facial zones. Subject satisfaction questionnaires were administered 3 weeks and 6 months after the last injection. Global aesthetic improvement and improvement on each treated zone as well as safety were evaluated. RESULTS: A high level of satisfaction was achieved throughout the study, with 96.5% of subjects at least satisfied with the full-facial aesthetic outcome at 3 weeks, and 92.9% at 6 months. More than 91% considered the treatment outcome to meet or surpass their expectations, and more than 94% would recommend the treatment to others. At Week 3, subject and investigator assessment showed aesthetic improvement for all subjects. The treatment was well tolerated. CONCLUSION: The combination of BoNT-A (s.U) and HA fillers results in high patient satisfaction and in an overall improvement of aesthetic outcomes and quality of life.

A subgroup analysis to evaluate the efficacy and safety of adapalene-benzoyl peroxide topical gel in black subjects with moderate acne.

Three multicenter, randomized, double blind, parallel-group, placebo controlled studies involving 3,855 subjects established the safety and efficacy of an adapalene benzoyl peroxide topical gel in the treatment of acne for all skin types. The data from these 3 studies were pooled and the subgroup of self-identified black subjects was analyzed separately. Significantly more black subjects had IGA success with adapalene-BPO than with vehicle at week 12. Significantly more black subjects also had decreased total, inflammatory, and noninflammatory lesion counts with adapalene-BPO that were seen as early as week 1. Adapalene-BPO was well tolerated in the black subjects included in this analysis and no cases of treatment-related PIH were observed. Similar results were obtained for this subgroup as the overall population from the 3 studies. Based on the results from this analysis, adapalene-BPO is a safe and effective treatment for acne in black skin.

Full-face rejuvenation using a range of hyaluronic acid fillers: efficacy, safety, and patient satisfaction over 6 months.

BACKGROUND: Full-face rejuvenation with dermal fillers in patients with multiple aesthetic indications is rarely studied. OBJECTIVE: To assess whether a new range of hyaluronic acid filler is suitable for full-face rejuvenation and to evaluate efficacy, safety, and patient satisfaction. MATERIALS AND METHODS: In this 6-month study, participants could receive five different fillers from the same range (HA(E) )for up to eight indications (periorbital lines, tear troughs, cheeks, cheek folds, nasolabial folds, upper lip lines, lips, and marionette lines). Outcomes included global aesthetic improvement, improvement in each indication, adverse events, local tolerability, and satisfaction. RESULTS: Seventy-seven participants with a mean age of 54.5 were enrolled; 48.1% had five or more indications treated. Mean total injection volume (baseline and touch-up) per participant was 6.7 mL. At month 6, 92.1% of participants remained at least improved over baseline, 79.7% of participants were satisfied or very satisfied with the durability of the results, and 63.0% of participants felt a lot or much better than before injection. No specific safety concerns were reported except expected injection site reactions. CONCLUSION: In participants with multiple indications, full-face rejuvenation using HA(E) provided effective, safe, satisfactory results.

Adjunctive use of a facial moisturizer SPF 30 containing ceramide precursor improves tolerability of topical tretinoin 0.05%: a randomized, investigator-blinded, split-face study.

OBJECTIVES: To assess the benefit of adjunctive use of a SPF 30 moisturizing lotion in reducing local side effects associated with atopical tretinoin cream. METHODS: This was a randomized, investigator/evaluator-blinded, split-face comparison in subjects with healthy skin. Subjects applied tretinoin cream 0.05% once daily to the whole face and Cetaphil 174; Dermacontrol Moisturizer (CDM) once daily to one side of the face based on randomization. Tolerability, perference and skin hydration were evaluated at each week, and a cosmetic acceptability questionnaire regarding CDM was completed at the end of the study. RESULTS: The majority (about 83% to 86%) of subjects experienced skin irritations on both sides of their face, though predominantly mild for the CDM + tretinoin treated side. Tolerability preferences favored the CDM+tretinoin sides. Adjunctive use of CDM with a topical tretinoin cream improves tolerance of the treatment.

Sustained efficacy and high patient satisfaction after cheek enhancement with a new hyaluronic acid dermal filler.

BACKGROUND: Increasing volume is an important part of facial rejuvenation since volume loss is common and typically age-related. HA E Volume is a moderately firm gel designed to be injected into the subcutaneous tissue for volume enhancement. OBJECTIVE: To assess the efficacy, patient satisfaction, and safety fo HA E Volume in patients with bilateral volume loss of the cheeks. MATERIALS AND METHODS: This was a multi-center, six-month, open-label study. Subjects received HA E in the cheeks at baseline, and a touch-up injection was optional three weeks later. Global aesthetic improvement, cheek thickness (caliper measurements),changes in volume using three-dimensional (3-D) photo analysis, adverse events and injection site reactions were evaluated at each visit. Optimal correction was defined as results obtained three weeks after last injection. A subject satisfaction questionnaire was performed three weeks after the last injection. RESULTS: Investigators evaluated the great majority of subjects as much or very much improved in terms of aesthetic improvement of their cheeks at week 3 and at mounts 3 and 6 (89.3%, 90.9%, and 76.4%, respectively). After six months, 65.8 percent of the correction achieved at week 3 (optimal correction) was maintained in terms of cheek thickness (caliper assessments), confirmed by 67.7 percent of the volume maintained based on 3-D volume analyses. The majority of subjects (92.1%) were satisfied or very satisfied with their aesthetic outcome. A good tolerability profile was observed. CONCLUSIONS: Treatment with HA E Volume in cheeks led to good aesthetic improvement, sustained results confirmed by caliper and 3-D volume assessments, and high subject satisfaction.

Perioral rejuvenation with a range of customized hyaluronic acid fillers: efficacy and safety over six months with a specific focus on the lips.

BACKGROUND: Injectable fillers are frequently used to restore volume and correct wrinkles in perioral region. However, evidence for perioral indications is scarce. OBJECTIVE: Assess the efficacy, patient satisfaction, and safety of new range of hyaluronic acid fillers (HA E) in perioral enhancement. MATERIALS AND METHODS: This was a multi-center, six-month, open-label study. At baseline, subjects could receive HA E Touch, HA E Classic, HA E Lips and HA E Deep for the treatments of lips, upper lip lines, nasolabial folds and marionette lines, and a touch-up infection was optional three weeks later. Lip Fullness Grading scale (for lips), wrinkle assessments (Lemperle Rating Scales for the remaining indications), adverse events, and local tolerance were evaluated at each visit, and 3-D volume analyses (for nasolabial folds and lips only) at each post-baseline visit. Optimal correction was defined as results obtained three weeks after last injection. A subject satisfaction questionnaire was performed three weeks after last infection. RESULTS: Overall, HA E Lips was infected for lip enhancement, HA E Thouch and HA E Classic for upper lip lines, and HA E Classic and HA E Deep for both nasolabial folds and marionette lines. After six month, around a 1-grade improvement persisted according to the lip fullness and wrinkle assessment scales. The long duration of effect was confirmed by 3-D analyses, with 62.7-71.4 percent of volumes obtained at week 3 (optimal correction) maintained after six months. The majority of subjects (from 80% for upper lip lines with HA E Classic to 94.8% for nasolabial folds with HA E Deep) were satisfied or very satisfied with their aesthetic outcome. All products were safe and well-tolerated. CONCLUSIONS: Perioral enhancement with HA E fillers led to sustained effect in terms of lip fullness, wrinkle and 3-D volume assessments, and high subject satisfaction.

Correction of tear troughs and periorbital lines with a range of customized hyaluronic acid fillers.

BACKGROUND: The periorbital region is a challenging area for injectable filler. Overcorrection and/or the use of unsuitable fillers may lead to unwanted results. As evidence for this region is limited, most physicians follow a trial and error approach. OBJECTIVE: Assess the efficacy, patient satisfaction, and safety of the HA E filler range in periorbital rejuvenation. MATERIALS AND METHODS: This was a multi-center, six-month, open-label study. Subjects could receive HA E Touch, HA E Classic, and HA E Deep for the treatment of tear troughs and periorbital lines at baseline, and an optional touch-up three weeks later. Global aesthetic improvement for both indications, periorbital wrinkle assessments (Lemperle Rating Scale), 3-D volume analysis (for tear troughs only), adverse events and injection site reactions were evaluated at each visit. A subject satisfaction questionnaire was performed three weeks after last injection. RESULTS: Overall, HA E Classic and Deep were infected for tear troughs, and HA E Touch for periorbital lines. Mean aesthetic improvement in tear troughs was 1.5-2 grades for both products at each post-baseline visit, and results of the clinical evaluation were confirmed by results of 3-D volume analysis. Improvements of periorbital lines in both aesthetic outcomes and wrinkle severity were around 1.5 grades at week 3, and close to 1 grade at month 6. The majority of subjects were satisfied or very satisfied with their aesthetic outcome. Treatments of both indications were safe and well-tolerated, with only mild and transient injection site reactions reported. CONCLUSIONS: This HA E filler range is suitable for rejuvenation of the periorbital region, which leads to safe results, long-lasting efficacy and high levels of patient satisfaction.

Short-term combination therapy and long-term relapse prevention in the treatment of severe acne vulgaris.

Few long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P<.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects.

The efficacy of adapalene-benzoyl peroxide combination increases with number of acne lesions.

BACKGROUND: There is no direct correlation between acne severity and lesion numbers and patients with moderate acne may present with varying lesion counts. The fixed-dose adapalene 0.1%-benzoyl peroxide (BPO) 2.5% combination gel is an efficacious and safe acne treatment. OBJECTIVE: We sought to evaluate whether the benefit of adapalene-BPO relative to vehicle varies with baseline lesion counts. METHODS: Data were pooled from 3 randomized, double-blind, controlled studies, which compared efficacy in 4 treatment groups (adapalene-BPO, adapalene, BPO, and the gel vehicle). Three lesion count subgroups (Low, Mid, and High) were defined based on the number of total, inflammatory, or noninflammatory lesion at baseline. Efficacy of each treatment and benefit of each treatment relative to vehicle were evaluated on the entire population and in all lesion count subgroups. Safety was assessed by local tolerability score and adverse events. RESULTS: Adapalene-BPO provided significant benefit relative to vehicle and monotherapies on the entire population and in all lesion count subgroups (P < .05). At study end point, the benefit of adapalene-BPO relative to vehicle was greatest in the High subgroup, suggesting that patients with the highest baseline lesion counts contributed the most to the treatment benefit observed in the entire population. This effect was only observed with adapalene-BPO and not with monotherapies. Higher baseline lesion counts did not lead to more related adverse event or worse tolerability score for adapalene-BPO. LIMITATION: These results were generated from clinical trials. Results in clinical practice could differ. CONCLUSION: The relative benefit of adapalene-BPO increases with higher lesion counts at baseline.

Treatment of 2,453 acne vulgaris patients aged 12-17 years with the fixed-dose adapalene-benzoyl peroxide combination topical gel: efficacy and safety.

Acne vulgaris is a common disease in adolescents, and early treatment may minimize its physical and psychological effects. A fixed-dose combination gel of adapalene 0.1% and benzoyl peroxide 2.5% (adapalene-BPO) is efficacious and safe in the treatment of acne patients aged 12 years or older, as demonstrated in three randomized and controlled studies. The current study is a subgroup analysis of the efficacy and safety of adapalene-BPO among 2,453 patients aged 12-17 years. After 12 weeks of treatment, significantly more patients in the adapalene-BPO group were "clear" or "almost clear" (30.9%, P < 0.001) compared to the monotherapies and vehicle. The percentage reduction from baseline in total, inflammatory and non-inflammatory lesions was 56, 63 and 54.5 percent in the adapalene-BPO group, respectively, significantly higher than in the monotherapy groups and vehicle (all P < 0.001). Significantly earlier onset of effect was observed at week 1. Adapalene-BPO was also well tolerated, with the mean scores of dryness, erythema, scaling and stinging/burning less than 1 (mild) at all study visits. Overall, the adapalene-BPO combination gel provides significantly greater and synergistic efficacy and a fast onset of action compared to the monotherapies and vehicle in young acne patients aged 12-17 years.

Clobetasol propionate shampoo 0.05% is efficacious and safe for long-term control of scalp psoriasis.

Clobetasol propionate (CP) shampoo 0.05% is an efficacious and safe treatment for scalp psoriasis. The aim of this double-blind, randomized, placebo-controlled study was to determine if CP shampoo is suitable for long-term disease control. Participants with moderate to severe scalp psoriasis (global severity score [GSS] of 3 or 4 on a scale of 0 [clear] to 5 [very severe]) first received once daily CP shampoo treatment for up to 4 weeks. Responders were subsequently randomized to receive the CP shampoo or vehicle twice weekly maintenance regimen for up to 6 months. When relapse occurred (defined as GSS > 2), participants resumed once daily CP shampoo treatment; when symptoms diminished (GSS < or = 2), they readopted the twice weekly maintenance regimen. At all visits significantly more participants treated with CP shampoo did not relapse compared with participants treated with vehicle (P < .001). Only approximately one-third of participants treated with vehicle remained relapse free at 1 month, while this rate was observed approximately 3.5 months later (4.5 months after baseline of maintenance phase) in the CP shampoo group. After 6 months 31.1% (33/106) of participants in the CP shampoo group were still relapse free versus 8.1% (9/111) of participants in the vehicle group. There was no greater incidence of skin atrophy, telangiectasia, or hypothalamic-pituitary-adrenal (HPA) axis suppression in the CP shampoo group compared with the vehicle group. Clobetasol propionate shampoo is efficacious and safe for acute management and long-term maintenance of moderate to severe scalp psoriasis.

Effective and safe combination therapy for severe acne vulgaris: a randomized, vehicle-controlled, double-blind study of adapalene 0.1%-benzoyl peroxide 2.5% fixed-dose combination gel with doxycycline hyclate 100 mg.

There is a paucity of treatment options for severe acne vulgaris aside from oral isotretinoin. This randomized, vehicle-controlled, multicenter, double-blind study evaluated the efficacy and safety of combination therapy using adapalene 0.1%-benzoyl peroxide 2.5% (A/BPO) fixed-dose combination gel with doxycycline hyclate 100 mg in the treatment of severe acne vulgaris. A total of 459 participants were randomized in a 1:1 ratio to receive oral doxycycline hyclate 100 mg once daily and either A/BPO or vehicle once daily for 12 weeks. Efficacy in the A/BPO with doxycycline group was demonstrated as early as week 2 compared with the vehicle arm for total, inflammatory, and noninflammatory lesions (all P < .005). At week 12, this combination was superior to vehicle with doxycycline in reducing total, inflammatory, and noninflammatory lesion counts (an added incremental benefit of 23%, 24%, and 21%, respectively), as well as for global success and overall participant satisfaction (all P < .001). Digital UV fluorescence photography demonstrated a rapid reduction in Propionibacterium acnes in the A/BPO with doxycycline group, particularly within the first 4 weeks. These findings provide evidence on the efficacy of combining A/BPO and the oral antibiotic doxycycline in the treatment of severe acne vulgaris.

Short-contact clobetasol propionate shampoo 0.05% improves quality of life in patients with scalp psoriasis.

Scalp psoriasis has a considerable impact on the quality of life (QOL) of patients, and most patients are dissatisfied with available treatments. Clobetasol propionate shampoo 0.05% has been shown to be effective and safe for moderate to severe scalp psoriasis. We evaluated the effect of clobetasol propionate shampoo on QOL and the degree of participant satisfaction with the product. Participants received once-daily treatment for up to 4 weeks. Their QOL and degree of satisfaction were evaluated by questionnaires. The mean (standard deviation) Dermatology Life Quality Index (DLQI) score decreased significantly from 7.0 (4.9) at baseline to 3.2 (3.2) at week 4 (P<.001). Participants who considered the disease as having a small effect or no effect on their QOL increased from 45.6% at baseline to 81.7% at week 4. Most participants were satisfied with the cosmetic acceptability and the efficacy and safety aspects of the product, considered it better than prior treatments, and would use it again in the future. Therefore, we conclude that treatment with clobetasol propionate shampoo improved the QOL of participants and resulted in high satisfaction.

Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne.

BACKGROUND: Scarring is a frequent consequence of acne. OBJECTIVES: Our objective was to evaluate the effect of up to 48 weeks' treatment with adapalene 0.3%/benzoyl peroxide 2.5% (A0.3/BPO2.5) gel on atrophic scars in moderate or severe acne vulgaris. METHODS: In Part 1 of this two-part study, A0.3/BPO2.5 gel or vehicle was applied on each half-face for 24 weeks in a randomized, investigator-blinded, split-face design. Part 2 was a 24-week, open-label extension phase during which A0.3/BPO2.5 gel was applied on both sides of the face. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, local tolerability, and safety. RESULTS: Of the 45 subjects entering Part 2, 41 completed the 48-week study. At baseline (Part 1), most subjects had moderate acne (93.3%) with mild scars (62.2%). The scar count decrease from baseline was 21.7% at week 24 and 26.9% at week 48 on the half-face treated for 48 weeks with A0.3/BPO2.5. For the half-face treated with vehicle followed by 24 weeks' A0.3/BPO2.5, scar count increased by 16.7% at week 24 (under vehicle) and decreased by 22.7% between weeks 24 and 48. The half-face that received 48 weeks' A0.3/BPO2.5 had a lower final atrophic scar count (mean 8.4 vs. 9.9 for the half-face with 24 weeks' vehicle then 24 weeks' A0.3/BPO2.5) and a higher percentage of SGA clear/almost clear. High reductions in acne lesions between baseline and week 48 were observed for both sides of the face. Long-term treatment with A0.3/BPO2.5 was safe and well-tolerated. CONCLUSIONS: Reductions in atrophic acne scars and acne lesions observed after 24 weeks of treatment with A0.3/BPO2.5 gel were maintained with treatment up to 48 weeks. The additional improvement in atrophic scar count with 48 weeks' A0.3/BPO2.5 treatment, compared to delayed application at 24 weeks, highlights the importance of early initiation of effective acne treatment to prevent and reduce the formation of acne scars. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02735421.