Triple combination CAB gel shows similar efficacy in males, females
Click Here to Manage Email Alerts
Key takeaways:
- Male and female patients with acne often present and have different skin physiology.
- Patients treated with triple combination CAB gel experienced similar efficacy and safety, regardless of sex.
Fixed-dose triple combination CAB gel showed efficacy in treating acne in both male and female patients aged 9 years and older, according to pooled data from two studies.
“Although acne afflicts both males and females, skin physiology and acne presentation vary by sex,” Edward (Ted) Lain, MD, MBA, executive director of the Austin Institute for Clinical Research, and colleagues wrote. “Males experience higher sebum production, less transepidermal water loss and lower skin pH compared with females. Females are more likely to experience drier and more sensitive skin.”
This subanalysis of two multicenter, randomized, double-blind, vehicle-controlled, parallel-group, phase 3 studies evaluated the efficacy of triple combination gel comprised of clindamycin phosphate 1.2%, adapalene 0.15% and benzoyl peroxide 3.1% (CAB; Cabtreo, Ortho Dermatologics) in patients stratified by sex. Treatment success was described as a reduction in inflammatory and noninflammatory lesion counts and a clear or almost clear Evaluator’s Global Severity Score (EGSS) with at least a 2-grade reduction from baseline.
The studies’ intent-to-treat populations totaled 212 females and 151 males, of which 95.9% and 89.9% completed treatment.
Treatment success occurred in 53.7% of females and 43.1% of males treated with CAB gel, compared with 23% and 24.6% of those in the vehicle groups at week 12 (P < .001 and P < .05, respectively).
Additionally, a least-squares mean percent reduction in inflammatory lesions of 77.7% was recorded in females and 77.5% of males using CAB gel compared with 57.9% and 57.1% of those using a vehicle gel (P < .001 for both). Noninflammatory lesions were reduced in 72.5% of females and 72.3% of males in the treatment groups vs. 45.6% and 49.6% of those in the vehicle groups (P < .001 for both).
No statistically significant difference in efficacy was found between sexes in the treatment groups.
Quality of life, as measured by least-square mean improvements from baseline in the four Acne-QoL domain scores, were also similar in female (CAB, 6.5-11.2; vehicle, 4-6.7; P .001) and male patients (CAB, 3.5-6.2; vehicle, 1.9-3.6; P < .01).
Treatment-emergent adverse events were also similar for females and males, with 27.1% and 27.6% of those in the treatment groups and 8.8% and 7.5% of those in the vehicle groups experiences adverse events. Pain, dryness, irritation, exfoliation, erythema and xerosis were the most common treatment-emergent adverse events.
“Differences in cutaneous physiology and acne presentation between the sexes may necessitate distinct approaches to acne treatment,” the authors wrote. “In this pooled post hoc analysis of two phase 3 trials, fixed-dose, triple combination CAB gel was efficacious and well tolerated in participants with moderate to severe acne, regardless of sex.”
Perspective
Back to Top
Multimodal topical therapy combining multiple mechanisms of action is a cornerstone of acne management. While adherence to acne regimens can be a challenge, fixed-dose combination products have been shown to improve adherence and clinical outcomes. Fixed-dose CAB is a novel treatment option, which in network meta-analyses has been found to have the highest efficacy of any topical product for the treatment of acne. In addition, it has an optimized vehicle, which can improve tolerability.
This secondary analysis of the phase 3 trial data highlight that fixed-dose CAB is similarly effective and well tolerated for both male and female patients with acne. Consistently high rates of treatment success and patient-reported outcome improvement were observed across both groups. For those looking for a convenient and highly effective treatment option that targets multiple mechanisms of action, fixed-dose CAB is an excellent addition to our acne treatment armamentarium. When combined with a topical antiandrogen such as clascoterone, all major pathophysiologic factors for acne can be addressed with only two topical products.
References:
Draelos ZD, et al. J Dermatolog Treat. 2023;doi:10.1080/09546634.2023.2220446.
Huang CY, et al. Ann Fam Med. 2023;doi:10.1370/afm.2995.
Reynolds RV, et al. J Am Acad Dermatol. 2024;doi:10.1016/j.jaad.2023.12.017.
Ryskina KL, et al. JAMA Dermatol. 2018;doi:10.1001/jamadermatol.2017.6144.
Yentzer BA, et al. Cutis. 2010;86(2):103-108.
Collapse
Read more about
Click Here to Manage Email Alerts