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Background: Patients with skin of color (SOC) and Fitzpatrick skin types (FST) IV–VI 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.

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.

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.

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.

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.

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.

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.

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.

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.