The Use of a Novel Artificial Intelligence Platform for the Evaluation of Rhytids.

BACKGROUND: Artificial intelligence (AI) platforms are increasingly being utilized in various healthcare applications. There are few platforms that provide quantifiable assessments of dermatologic or aesthetic conditions by employing industry established scales. OBJECTIVES: The authors sought to report the results of a pilot study that evaluated the utilization and functionality of an AI engine to measure and monitor rhytids (fine lines). For this study, glabellar frown lines were employed as the clinical model. METHODS: Seventy-one patients were enrolled and monitored remotely employing current high-quality mobile phone cameras over a 14-day period. The patients were prompted to take photographs employing this platform at preset intervals, and these photographs were then rated by the AI platform and qualified raters experienced in the field of facial aesthetics. RESULTS: The AI platform had concordance with 2 qualified raters of 46% to 68%, and the inter-rater concordance between 2 rates ranged from 44% to 66%. The intra-rater concordance for the raters was between 57% and 84%, whereas the AI platform had a 100% concordance with itself. The participant and investigator satisfaction ratings of the platform were high on multiple dimensions of the platform. CONCLUSIONS: This AI platform evaluated photos on a comparable level of accuracy as the qualified raters, and it evaluated more consistently than the qualified raters. This platform may have high utility in clinical research and development, including the management of clinical trials, and efficient management of patient care at the clinical practices.

Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0.

BACKGROUND: Persistent facial erythema is a clinically challenging feature of rosacea. OBJECTIVE: To evaluate persistent erythema reduction on the first day of treatment from pooled data from two pivotal trials of topical oxymetazoline cream 1.0% (oxymetazoline) in persistent facial erythema of rosacea. METHODS: In two identically designed, phase 3, multicenter trials, adults with moderate to severe persistent facial erythema of rosacea (Clinician Erythema Assessment [CEA] grade ≥3 and Subject Self-Assessment [SSA] grade ≥3) were randomized 1:1 to once-daily topical oxymetazoline or vehicle; the primary efficacy endpoint was ≥2-grade composite CEA and SSA improvement from baseline on day 29. This post hoc analysis evaluated the proportion of patients achieving ≥1-grade composite and individual CEA and SSA improvement at 1, 3, 6, 9, and 12 hours postdose on day 1 (N=885). RESULTS: Significantly more patients achieved ≥1-grade composite and individual CEA and SSA improvement with the first application of oxymetazoline than with vehicle (P less than 0.001) at all postdose time points, beginning with hour 1. Day 1 safety assessments were similar between treatments. LIMITATIONS: Short-term, post hoc analysis. CONCLUSIONS: A ≥1-grade improvement in persistent erythema achieved after the first dose of once-daily topical oxymetazoline demonstrated clinically meaningful improvement from the beginning of therapy. J Drugs Dermatol. 2018;17(6):621-626.

Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials.

BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

Clindamycin phosphate 1.2%-benzoyl peroxide (5% or 2.5%) plus tazarotene cream 0.1% for the treatment of acne.

Acne is a multifactorial chronic dermatosis that can be effectively treated with adjuvant medications. The objective of our study was to compare the tolerability and efficacy of 2 adjuvant therapies combining clindamycin phosphate 1.2%-benzoyl peroxide 5% (CLNP-BPO5) or clindamycin phosphate 1.2%-benzoyl peroxide 2.5% (CLNP-BPO2.5) fixed-dose gels with tazarotene (TZ) cream 0.1% (CLNP-BPO5/TZ vs CLNP-BPO2.5/TZ) when applied topically once daily for 12 weeks in participants with moderate to severe facial acne. Forty participants were randomized to receive CLNP-BPO5/TZ or CLNP-BPO2.5/TZ in a parallel-group study and were evaluated at baseline as well as weeks 1, 2, 4, 8, and 12 (or at early termination). In both groups, tolerability assessments increased by week 1 but gradually returned toward baseline levels by week 12. At week 4, the mean change in burning/stinging was significantly higher in the CLNP-BPO5/TZ group compared with the CLNP-BPO2.5/TZ group (P<.05). No other significant differences were observed for the tolerability, efficacy, quality of life (QOL), or participant preference assessments. Our study shows that CLNP-BPO5 or CLNP-BPO2.5 fixed-dose gels in combination with TZ cream 0.1% are generally well-tolerated and effective treatments of moderate to severe facial acne when applied once daily for up to 12 weeks.

Comparison of 2 clindamycin 1%-benzoyl peroxide 5% topical gels used once daily in the management of acne vulgaris.

Combination therapy for the topical treatment of acne vulgaris using benzoyl peroxide (BPO) and an antibiotic is more efficacious and better tolerated than treatment with either component alone. Moreover, the addition of BPO to antibiotic therapy is recommended as a means of preventing the development of Propionibacterium acnes antibiotic resistance. However, BPO is an irritant, and the dryness and irritation experienced by some patients using topical therapy containing BPO can negatively impact compliance. Historically, once-daily treatment application has enhanced compliance versus twice daily. The current 12-week study aimed to compare the efficacy of a clindamycin 1%-BPO 5% topical gel with the hydrating excipients dimethicone and glycerin (C/BPO HE) and a clindamycin 1%-BPO 5% topical gel that does not contain hydrating excipients (C/BPO) applied once daily for the treatment of 20 participants with facial acne vulgaris and to determine if there were differences in product preference and participant acceptability between the treatments. Both C/BPO HE and C/BPO were effective in the treatment of acne, with substantive reductions (-60.8% and -61.3%, respectively) in total inflammatory lesions at week 4 in both treatment groups. Participants receiving C/BPO HE demonstrated a more consistent treatment response than with C/BPO, with incremental reductions in total inflammatory lesions at each time point, whereas the response to C/BPO waned at week 8. As a result, greater percentage reductions in inflammatory and noninflammatory lesions were observed with C/BPO HE treatment than C/BPO treatment at week 8 (papules: -71.9% vs -49.4%, P=.053; pustules: -64.8% vs -28.0%, P=.134; open comedones: -44.5% vs 2.6%, P=.480; closed comedones: -35.5% vs -26.3%, P=.501). With the exception of papules, greater reductions in all lesion subtypes also were observed at week 12. None of the between-group differences reached statistical significance. Both treatment groups displayed similar disease signs and symptoms throughout the study period. However, scaling, erythema, dryness, and pruritus occurred more frequently in participants using C/BPO. Treatment satisfaction was greatest with C/BPO HE; participants reported that this formulation was easy to apply and 100% (9/9) of participants reported that they would continue using C/BPO HE compared with 80% (8/10) of participants using C/BPO. Both treatments were well-tolerated. In this pilot study, both formulations were effective in the treatment of inflammatory and noninflammatory acne lesions, but C/BPO HE produced a more consistent reduction in total inflammatory lesions over 12 weeks. The addition of hydrating excipients in the C/BPO HE formulation appears to improve patient tolerance and acceptance, which will likely help patients to comply with therapy.

Safety and Efficacy of EB-001, a Novel Type E Botulinum Toxin, in Subjects with Glabellar Frown Lines: Results of a Phase 2, Randomized, Placebo-Controlled, Ascending-Dose Study.

BACKGROUND: Botulinum neurotoxins, which are widely used commercially for therapeutic and cosmetic applications, have historically belonged to serotypes A and B. Serotype E has a distinct profile with a faster onset and shorter duration of effect. EB-001 is a proprietary formulation of serotype E in development for aesthetic (cosmetic) and therapeutic uses. METHODS: This first-in-human, randomized, double-blinded, placebo-controlled, ascending-dose cohort study enrolled 42 subjects who received EB-001 (n = 35) or placebo (n = 7). The efficacy primary outcome was the proportion of subjects with a two-grade investigator-rated improvement in glabellar frown line severity at maximum frown. Safety evaluations included adverse events, laboratory tests, and physical examinations. RESULTS: A two-grade investigator-rated response was observed starting in the third cohort (EB-001), with increased rates observed at higher doses. Onset of clinical effect was within 24 hours, with a duration ranging between 14 and 30 days for the highest doses. Adverse event incidence was low, with the most common being mild to moderate headache. There were no serious adverse events or ptosis, and there were no clinically significant changes in other safety assessments. CONCLUSIONS: In this clinical study in glabellar frown lines, EB-001 showed favorable safety, tolerability, and dose-dependent efficacy, with an 80 percent response rate at the highest dose. The maximum clinical effect of EB-001 was seen within 24 hours and lasted between 14 and 30 days. This differentiated EB-001 profile supports its development for aesthetic and therapeutic applications where fast onset and short duration of effect are desirable. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Tazarotene cream (0.1%) in combination with betamethasone valerate foam (0.12%) for plaque-type psoriasis.

A combination of multiple agents is often required to achieve treatment success for plaque-type psoriasis. We report a case series of 10 patients that were treated with betamethasone valerate foam (0.12%) in the morning and topical tazarotene cream (0.1%) in the evening for a total of 12 weeks or until plaques cleared. Erythema, scale, and thickness along with an aggregate severity score were determined at weeks 4, 8, and 12. One patient was lost to follow-up. Eight of the other 9 patients experienced improvement in their disease by week 12. Two patients were clear of their psoriasis at week 4 and 4 were clear at week 8. No adverse events, including irritation were reported; the use of the corticosteroid foam may protect against potential local irritation reported with tazarotene. The combination of tazarotene cream and betamethasone valerate foam is an effective combination approach to treating localized plaque-type psoriasis.