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.

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.

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.

The safety and efficacy of four different fixed combination regimens of adapalene 0.1%/benzoyl peroxide 2.5% gel for the treatment of acne vulgaris: results from a randomised controlled study.

BACKGROUND: Combined use of a retinoid and antimicrobial is recommended for acne, however, local tolerability issues may compromise patient adherence and treatment outcome. OBJECTIVES: This multicentre, single-blinded controlled study was designed to determine whether modified adapalene/benzoyl peroxide (A/BPO, Epiduo®, Galderma, France) regimens improve local tolerability during the first four weeks of treatment without impairing efficacy at Week 12. MATERIALS & METHODS: In total, 120 subjects with mild-to-moderate acne received, during the first four weeks, A/BPO daily overnight (A/BPO-EN), A/BPO daily for three hours (A/BPO-3h), A/BPO daily overnight and a provided moisturizer lotion (A/BPO-moisturizer), or A/BPO every other night (A/BPO-EoN). Local tolerance assessments included signs and symptoms, global worst score (GWS), and total sum score (TSS). Efficacy was assessed based on lesion counts, investigator global assessment (IGA), and total lesion count reduction. Adherence, subject satisfaction, and overall safety were also assessed. RESULTS: The mean TSS was significantly reduced at Week 1 with A/BPO-EoN vs. A/BPO-EN (p<0.05), and A/BPO-EoN led to the lowest GWS and a decrease in severity of stinging/burning and erythema (p<0.05). The A/BPO-moisturizer regimen prevented dryness and scaling compared with the A/BPO-EN regimen. The median decrease in lesions from baseline was similar in all groups: up to 67% for total, 72% for inflammatory, and 70% for non-inflammatory lesion counts. Adherence, IGA, patient satisfaction, and overall safety were excellent. CONCLUSIONS: Modulating treatment regimens during the first four weeks improved local tolerability without impacting overall efficacy outcome after 12 weeks and may improve treatment adherence during the first weeks of therapy.

Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison.

BACKGROUND: Very few clinical trials have investigated the effect of topical acne treatment on scarring. OBJECTIVES: Our objective was to evaluate the efficacy of adapalene 0.3%/benzoyl peroxide 2.5% gel (A0.3/BPO2.5) in atrophic acne scar formation in patients with acne. METHODS: In this multicenter, randomized, investigator-blinded, vehicle-controlled study, subjects with moderate or severe facial acne (Investigator's Global Assessment [IGA] score 3 or 4; ≥ 25 inflammatory lesions; ten or more atrophic acne scars) applied A0.3/BPO2.5 or vehicle daily per half face for 24 weeks. Subjects with acne requiring systemic treatment were excluded. Assessments included investigator atrophic acne scar count, Scar Global Assessment (SGA), acne lesion count, IGA, skin roughness and skin texture, subject self-assessment of clinical acne-related scars and satisfaction questionnaire, tolerability, and safety. RESULTS: Included subjects (n = 67) had mainly moderate acne (92.5% IGA 3); mean scores at baseline were approximately 40 acne lesions and 12 scars per half face. By week 24, the change from baseline in total scar count was - 15.5% for A0.3/BPO2.5 versus + 14.4% for vehicle (approximately 30% difference), with a mean of 9.5 scars versus 13.3 per half face, respectively (p < 0.0001). For SGA at week 24, a total of 32.9% with A0.3/BPO2.5 versus 16.4% with vehicle (p < 0.01) were clear/almost clear. Inflammatory acne lesions decreased by 86.7% for A0.3/BPO2.5 versus 57.9% for vehicle (p < 0.0001), and 64.2 versus 19.4% of subjects, respectively, were IGA clear/almost clear (p < 0.0001) at week 24. Treatment-related AEs were reported by 20.9% for A0.3/BPO2.5 versus 9% for vehicle side, most commonly skin irritation (14.9 vs. 6%, respectively). CONCLUSIONS: Topical A0.3/BPO2.5 prevented and reduced atrophic scar formation. Scar count increased with vehicle (+ 14.4%) but decreased with A0.3/BPO2.5 (- 15.5%) over 24 weeks. TRIAL REGISTRY: ClinicalTrials.gov identifier NCT02735421.

Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars.

INTRODUCTION: Scarring is an unfortunate clinical outcome of acne. Current treatment options for atrophic acne scars are dominated by non-pharmacological, invasive procedures which may not be suitable or affordable to all patients. This phase II, single-center, open-label, exploratory study assessed the efficacy, safety and subject-reported outcomes of adapalene 0.3% gel in the treatment of atrophic acne scars. METHODS: The study included subjects aged 18-50 years with past history of acne and moderate to severe facial atrophic acne scars. Subjects received adapalene 0.3% gel once daily for the first 4 weeks and twice daily for the following 20 weeks. Assessments were performed at baseline, day 10 and weeks 4, 8, 16 and 24, and at post-treatment follow-ups (weeks 36 and 48-72). RESULTS: At week 24, investigator and subject assessments reported improvement in skin texture/atrophic scars in 50% and > 80% of subjects, respectively. Subjects were satisfied with the treatment and reported improvements in quality of life. CONCLUSION: Daily use of adapalene 0.3% gel for the treatment of atrophic acne scars showed promising clinical efficacy, a favorable tolerability profile, and improvement in quality of life. FUNDING: Nestlé Skin Health-Galderma R&D. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01213199.

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.

Combination of benzoyl peroxide 5% gel with liquid cleanser and moisturizer SPF 30 in acne treatment results in high levels of subject satisfaction, good adherence and favorable tolerability.

BACKGROUND: Skin care products (cleansers and moisturizers) to complement benzoyl peroxide (BPO) in the treatment of acne may improve treatment tolerability and adherence. OBJECTIVE: Evaluate subject satisfaction after use of BPO 5% gel in combination with liquid cleanser and moisturizer SPF 30. METHODS: Open-label study including subjects aged ≥12 years with mild-to-moderate facial acne; ClinicalTrials.gov Identifier: NCT02589405. Once daily BPO 5% gel, twice daily liquid cleanser and once daily moisturizer SPF 30 were applied for 12 weeks. Assessments included a subject satisfaction questionnaire, investigator global assessment of improvement, lesion counts, the presence of Propionibacterium acnes, and safety. RESULTS: Fifty subjects were enrolled. Most subjects were overall satisfied with the three-part regimen (87%) and felt better about themselves (94%). Subjects indicated the skin care products helped prepare the skin for treatment (85%), relieve itchy skin (81%) and reduce irritation (87%). Most subjects considered that the liquid cleanser (80%) and moisturizer SPF 30 (84%) were a necessary part of acne treatment. BPO reduced P. acnes load by 89% at week 1. The treatment was well tolerated. CONCLUSIONS: The combination of BPO 5% gel with liquid cleanser and moisturizer SPF 30 resulted in high levels of subject satisfaction, good tolerability and treatment adherence.

Prolonging Time to Flare in Pediatric Atopic Dermatitis: A Randomized, Investigator-Blinded, Controlled, Multicenter Clinical Study of a Ceramide-Containing Moisturizer.

INTRODUCTION: Delaying or preventing flares is important in atopic dermatitis (AD) management. The objective of the study was to evaluate whether using a ceramide-containing moisturizer in addition to a body wash during latent AD can delay flares. METHODS: This was a randomized, investigator-blinded, parallel-group, controlled study among Chinese children with a history of mild to moderate AD, within 1 week of successful treatment with a topical corticosteroid. Subjects were randomized to receive moisturizer twice daily and body wash once daily, or body wash alone once daily for 12 weeks. The primary efficacy endpoint was time to flare [necessitating medical therapy and/or Investigator Global Assessment (IGA) > 1 (at least mild AD)]. Other efficacy endpoints were AD characteristics and emollient effects. The patient-reported outcome comprised satisfaction at week 12. The safety endpoint was incidence of undesirable events. RESULTS: A total of 64 subjects aged 2-12 years were randomized. Median time to flare was delayed by nearly 2 months for moisturizer/body wash compared to body wash alone (89 vs. 27 days, respectively). A significantly earlier onset of action in terms of fewer flares favoring moisturizer was found at week 4 (31 vs. 59%, respectively, p = 0.022), and after 12 weeks, fewer flares occurred (50 vs. 72%). At week 12 for flare-free subjects, nearly half in both groups had clear IGA, and an emollient effect in terms of less dryness or burning was more marked for moisturizer/body wash. Both products led to high patient satisfaction and were well tolerated. CONCLUSION: A regimen incorporating a moisturizer plus body wash delayed AD flares by nearly 2 months compared to body wash alone, and yielded high patient satisfaction. FUNDING: Galderma R&D. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02589392.

Use of Supplementary Patient Education Material Increases Treatment Adherence and Satisfaction Among Acne Patients Receiving Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in Primary Care Clinics: A Multicenter, Randomized, Controlled Clinical Study.

INTRODUCTION: Poor adherence to acne treatment may lead to unnecessary treatments, increased healthcare costs, and reduced quality of life (QoL). This multicenter study evaluated the effect of supplementary patient education material (SEM) (a short video, information card, and additional information available online) on treatment adherence and satisfaction among acne patients treated with the fixed-dose combination adapalene 0.1%/benzoyl peroxide 2.5% gel (A/BPO) in primary care clinics versus (1) standard-of-care patient education (SOCPE) (package insert and oral instruction) and (2) SOCPE plus more frequent clinic visits. METHODS: Subjects with acne were randomized to receive once-daily A/BPO for 12 weeks plus (1) SEM in addition to SOCPE; (2) SOCPE only with two additional visits; or (3) SOCPE only. Other assessments included a subject appreciation questionnaire, a physician questionnaire, and safety. RESULTS: Ninety-seven subjects were enrolled. At baseline, most (87.6%) had mild to moderate acne. Better adherence was observed in the A/BPO + SEM group compared with A/BPO + more visits or A/BPO alone [mean 63.1%, 48.2% (p = 0.0206), and 56.5%, respectively]. The A/BPO + SEM group had more subjects with greater than 75% adherence (45%, 30.4%, and 25%, respectively). According to the subject appreciation questionnaire, the SEM was more helpful to adhere to treatment (56.7%) versus more visits (32.3%) and A/BPO alone (15.2%), better use the product (70%, 61.3%, and 54.5%, respectively), and better manage skin irritation (53.3%, 48.4%, and 36.4%, respectively). All physicians were satisfied with the SEM and 90% would consider using it in their practice. Safety assessment showed fewer treatment-related adverse events in the A/BPO + SEM group. CONCLUSION: Use of the SEM may increase adherence of acne patients treated with once-daily A/BPO gel in primary care, consequently improving treatment and QoL in the long term. FUNDING: Nestle Skin Health-Galderma R&D. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02307266.

High Patient Satisfaction with Daylight-Activated Methyl Aminolevulinate Cream in the Treatment of Multiple Actinic Keratoses: Results of an Observational Study in Australia.

INTRODUCTION: Actinic keratoses (AK) are treated to reduce the risk of progression to squamous cell carcinoma and for symptomatic and cosmetic benefits. The objective of this observational study was to generate real-life data on the use of daylight photodynamic therapy with methyl aminolevulinate cream (MAL DL-PDT) in treating mild to moderate facial/scalp AK. METHODS: A multicenter, prospective, observational study was conducted in Australia in patients receiving a single treatment of MAL DL-PDT for mild to moderate AK. Efficacy was assessed 3 months after treatment by investigator-assessed improvement and patient- and physician-completed satisfaction questionnaires. Adverse events were recorded throughout the study. RESULTS: Overall, 81 patients were enrolled of mean age 62.7 years, mostly men (76.5%) with skin phototype I (64.2%) or II (35.8%) and a long history of AK (mean duration 16.8 years). Most had multiple lesions (82.7% had >10 lesions) of predominantly grade I (75.3%). At 3 months after treatment, almost half the patients (46.8%) required no further treatment. The proportions of patients and physicians satisfied to very satisfied with the MAL DL-PDT treatment were 79.7% and 83.3%, respectively. After receiving the treatment, 74.1% of patients indicated via the questionnaire that they were not bothered at all by the pain. Related AEs were reported in 48.1% of patients, mainly mild erythema (44.4%). CONCLUSIONS: In clinical practice in Australia, the use of MAL DL-PDT in treating multiple mild to moderate non-hyperkeratotic AK of the face and/or scalp results in high levels of patient and physician satisfaction reflecting the good efficacy and tolerability of this almost painless, convenient procedure. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02674048. FUNDING: Galderma R&D.

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.

Defining treatment success in rosacea as 'clear' may provide multiple patient benefits: results of a pooled analysis.

BACKGROUND: Rosacea treatment success is usually defined as a score of 1 ('almost clear') or 0 ('clear') on the 5-point Investigator Global Assessment (IGA) scale. OBJECTIVE: To evaluate whether, after successful treatment, 'clear' subjects had better outcomes than 'almost clear' subjects. METHODS: A pooled analysis was performed on 1366 rosacea subjects from four randomized controlled trials with IGA before and after treatment (ivermectin, metronidazole or vehicle). Assessments included the Dermatology Life Quality Index (DLQI) questionnaire and subject assessment of rosacea improvement. In one trial, patients were followed after the treatment period to measure time to relapse (IGA score ≥2). RESULTS: At end of treatment, more 'clear' than 'almost clear' subjects had a clinically meaningful difference in DLQI (59% vs. 44%; p < .001) and a final DLQI score of 0-1 indicating no effect on quality of life (84% vs. 66%; p < .001). More 'clear' subjects reported an 'excellent' improvement in their rosacea (77% vs. 42%; p < .001). The median time to relapse was more than 8 months for 'clear' vs. 3 months for 'almost clear' subjects (p < .0001). CONCLUSIONS: Achieving an endpoint of 'clear' (IGA 0) vs. 'almost clear' (IGA 1) is associated with multiple positive patient outcomes, including delayed time to relapse.

Erythema of Rosacea Impairs Health-Related Quality of Life: Results of a Meta-analysis.

INTRODUCTION: The central diagnostic feature of rosacea is diffuse central-facial erythema. The objective was to summarize published and unpublished health-related quality of life (HRQoL) data from seven previous studies in rosacea patients. METHODS: A meta-analysis was performed on baseline HRQoL data of subjects with erythema of rosacea from five randomized controlled trials, one open-label safety study and one epidemiological study. The data from four questionnaires were analyzed, including the Euro QoL 5-dimension (EQ5D) generic questionnaire, the Dermatology Life Quality Index (DLQI) dermatology-specific quality of life instrument, the Productivity and Social Life Questionnaire and the Facial Redness Questionnaire. RESULTS: The global EQ5D index score was 0.859 and the domains of pain/discomfort (31.5% moderate or extreme pain) and anxiety/depression (26.4% moderate or extreme) were most affected. Worse scores were observed with erythema of rosacea in the absence of inflammatory lesions (EQ5D score of 0.832 for no lesions vs 0.919 for subjects with ≥1 lesion). Almost half (43%) the subjects had at least moderately impaired HRQoL, including 19.8% with a DLQI total score of ≥11 indicating severely impaired HRQoL; symptoms/feelings was the most affected domain. Subjects with a patient self-assessment (PSA) of severe erythema of rosacea had a worse mean DLQI score than moderate PSA subjects (8.6 vs 6.0). Work life and social life were affected, especially in subjects with severe PSA (62% with social life at least somewhat affected). CONCLUSION: Erythema of rosacea causes a marked decrease in HRQoL in most patients, especially those with self-perceived severe erythema and without inflammatory lesions, and should thus be considered as an important medical problem requiring medical intervention. FUNDING: Galderma UK.

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.

Adapalene-benzoyl Peroxide Gel is Efficacious and Safe in Adult Female Acne, with a Profile Comparable to that Seen in Teen-aged Females.

Objectives: To evaluate the efficacy and safety of adapalene 0.1% benzoyl peroxide 2.5% gel in women aged 25 years or older via subgroup analysis of existing Phase 2 and 3 study data. Methods: Meta-analysis of pooled data from three multicenter, randomized, double-blind, vehicle-controlled, parallel-group, clinical trials compared results of treatment with either adapalene 0.1% benzoyl peroxide 2.5% gel or vehicle gel in adult females and teen-aged females. Efficacy assessments included investigator's global assessment and median percent change in acne lesions. Safety assessments included skin tolerability and adverse events. Results: Two hundred fifty-four adult females and 488 teen-aged females were included in the analyses, and baseline characteristics were comparable between subjects receiving adapalene 0.1% benzoyl peroxide 2.5% or vehicle. Both adult females and teen-aged females in the adapalene 0.1% benzoyl peroxide 2.5% arm were significantly more often rated clear/almost clear compared with those in the vehicle arm at Weeks 8 (P=0.016) and 12 (P<0.001); at endpoint, success was achieved in 39.2 percent with adapalene 0.1% benzoyl peroxide 2.5% and 18.5 percent with vehicle. Comparison of the amount of difference between active and vehicle reductions in investigator's global assessment showed that efficacy was similar for adult females versus teen-aged females (20.7% vs. 19.9%, respectively). Adapalene 0.1% benzoyl peroxide 2.5% had a rapid onset of action, with statistically significant reductions in all acne lesion types versus vehicle observed by Week 1. Adapalene 0.1% benzoyl peroxide 2.5% was safe and well-tolerated by adult females with a tolerability profile consistent with that seen in teen-aged females. Conclusions: The once-daily fixed-dose combination product adapalene 0.1% benzoyl peroxide 2.5% is an efficacious, safe, and well-tolerated treatment for adult female acne, with a profile similar to that in teen-aged females.

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.

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.

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.