AIM:Given the chronic nature of acne, two 6-month studies were conducted to evaluate the long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB)-the only approved triple-combination acne topical-and its effects on scarring/dyspigmentation in participants with moderate to severe acne. MATERIALS AND METHODS:Data were pooled from 2 identical, open-label, single-center studies conducted in participants (N = 50) aged ≥12 years with Investigator's Global Assessment (IGA) score of 3/4. Endpoints included change from baseline in IGA score, inflammatory/noninflammatory lesions, skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), and scarring. Adverse events and tolerability (itching, burning, redness, swelling) were assessed. RESULTS:At week 24, 67% of participants achieved treatment success, and significant reductions from baseline in inflammatory (88%) and noninflammatory (68%) lesions were observed (p < 0.001, both). Significant reductions in scarring (33%), investigator- and participant-assessed PIH (71%; 78%, respectively), and PIE (77%; 77%, respectively) were demonstrated (p < 0.001, all). Most participants (>70%) reported no tolerability issues throughout the studies. Seven adverse events occurred; 4 were related to CAB, and 3 led to study discontinuation (BPO allergy [n = 2], irritant contact dermatitis to BPO [n = 1]). CONCLUSIONS:These findings suggest that CAB is an appropriate and effective topical option for the long-term treatment of acne vulgaris.
Introduction Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel—the only approved triple-combination acne topical—was efficacious and well tolerated in 12-week clinical trials and in 24-week studies. Acne presentation and sequelae vary by skin type, requiring long-term management strategies to account for differences in skin pigmentation. This post hoc analysis assessed long-term efficacy and tolerability of acne treatment with CAB gel in participants with Fitzpatrick skin phototypes IV-VI. Methods Data were pooled from 2 identical, postmarketing, 24-week, single-center, open-label studies of once-daily CAB gel in 50 participants ≥12 years with moderate to severe acne (Investigator’s Global Assessment [IGA] score=3 or 4). Endpoints included changes from baseline in IGA score and inflammatory/noninflammatory lesions at week 24. Scarring (assessed using the Goodman Qualitative Scar Scale), skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), tolerability (itching, burning, redness, swelling), and adverse events (AEs) were evaluated. Results Of 24 participants with Fitzpatrick skin types IV-VI, 22 completed the studies. Participants were a mean age of 26.6 years and 86.4% were female. At week 24, 73% of participants achieved treatment success (≥2-grade reduction from baseline in IGA score and clear/almost clear skin), with reductions in inflammatory and noninflammatory lesions of 90% and 66%, respectively. PIH, PIE, and scarring improved from baseline by 71%, 87%, and 32%, respectively. No participants reported tolerability issues at week 24 and all had skin dryness scores of 0 (none). One participant experienced an AE (bronchitis), which was deemed unrelated to study product. Conclusions In participants with darker skin phototypes, 6 months of once-daily CAB gel use led to 73% treatment success and inflammatory lesion reductions of 90%. These improvements are higher than those seen at week 12 in the pivotal trials and support the long-term use of CAB gel in patients with darker skin phototypes.
Importance:Currently, there are no standardized outcome domains or measures in clinical trials for facial aging. Heterogeneity in outcome domains and measurement instruments across clinical trials creates difficulty in directly comparing interventions, determining superior therapies, and developing high-quality meta-analyses. Objective:To develop a core outcome set (COS) of essential domains to be reported in clinical trials evaluating the efficacy of interventions for facial aging. Evidence Review:PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL were searched from September 2005 to September 2015. An updated search of the same databases was performed from September 2015 to February 2026. Studies were included if (1) they were randomized clinical trial or controlled clinical trial in design, (2) they assessed the efficacy or safety of an intervention for facial aging, (3) they were published in English, and (4) they involved human participants. Complementary sources, including patient interviews, were used to capture further relevant outcomes. Two rounds of Delphi surveys, followed by consensus meetings, were used to identify outcome domains considered most important by both patient and physician stakeholders. Findings:The final COS consists of 6 outcome domains: (1) overall convenience of treatment; (2) time to return to normal work and social activity; (3) overall assessment of focused area of treatment (at the point in time when treatment is expected to provide peak benefit); (4) duration of treatment effect; (5) severity of persistent local or systemic adverse events, including pigmentary change, skin texture change, delayed healing, scarring, and serious adverse events; and (6) patient satisfaction with treatment. Conclusions and Relevance:The 6 outcome domains identified through a Delphi consensus are recommended for reporting in future facial aging trials to ensure that outcomes that matter most to patients and clinicians are measured and that results are comparable across interventions.
Hair thinning is a prevalent concern influenced by multiple factors including stress, hormonal changes, diet, and lifestyle, with varying impacts across demographic groups. Oral supplements addressing these key root causes through a multi-targeting, patented, botanical-based Synergen Complex have been developed to combat hair thinning across different populations. This study sought to build on existing evidence from previous clinical studies evaluating hair growth and quality by evaluating the effectiveness of these nutraceuticals in enhancing hair fiber diameter, and thus hair strength and length, in adults with thinning hair. This 6-month, prospective, open-label study included women, plant-based women, menopausal women, parous women, and men consuming commercially available hair growth nutraceuticals (HGNs) targeted to different demographics (Nutrafol® Women, Vegan, Balance, Postpartum, and Men). All subjects had hair thinning, self-reported and confirmed by the study dermatologist. Assessments occurred at baseline, day 90, and day 180. Measurements included hair shaft diameter via light microscopy, hair breakage/shedding via a four-region hair pull test, investigator global assessment (IGA) of hair parameters, and subject self-perception questionnaire. A total of 252 participants enrolled, with 244 completing the study per protocol. Ingestion of the HGNs was associated with a significant increase in hair shaft diameter across all groups by day 180. Hair pull tests showed significant reductions in intact, broken, and total hair shedding overall. In-person IGA was correlated with significant improvements in hair attributes—strength, length, thickness, and overall hair health—across all groups. Self-perception data revealed strong agreement across groups with statements regarding hair improvements by day 180. This study demonstrates that ingestion of these bio-specific HGNs are associated with significantly enhanced hair shaft diameter and decreased breakage, resulting in longer, stronger hair across their intended populations. These findings support the use of these HGNs for hair thinning, offering alternative options for various populations for improving hair growth and thickness. ClinicalTrials.gov identifier, NCT06362941.
