J Drugs Dermatol. 2024 Nov 1;23(11):1017-1024. doi: 10.36849/JDD.8639.
Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In 3 clinical studies of participants with moderate-to-severe acne, CAB demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Detailed efficacy/safety data from individual clinical study participants are presented.
In two phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged at least 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Descriptive data - including lesion count changes, treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin), compliance, treatment-emergent adverse events (AEs), and cutaneous safety/tolerance assessments - were summarized from 6 CAB-treated cases.
By week 12, all cases achieved >70% lesion reductions, 4/6 achieved treatment success, and 1/6 achieved a 2-grade reduction in severity. All cases were compliant with CAB treatment. No cases reported serious AEs. Transient increases occurred on cutaneous safety and tolerability assessments, with scores generally decreasing back to/below baseline levels by week 12.
In two phase 3 clinical trials, fixed-dose, triple-combination CAB demonstrated good efficacy/safety. All 6 CAB-treated cases achieved substantial (>70%) lesion reductions, with 5/6 achieving treatment success or 2-grade reduction in severity by week 12. Transient cutaneous safety/tolerability severity increases generally resolved to baseline values by week 12. These clinical study cases reinforce the importance of patient education regarding adherence, expectations, and AEs. J Drugs Dermatol. 2024;23(11):1017-1024. doi:10.36849/JDD.8639.
克林霉素磷酸酯 1.2%/阿达帕林 0.15%/过氧苯甲酰 3.1%（CAB）凝胶是唯一一种固定剂量的三联组合制剂，被批准用于治疗痤疮。在三项针对中重度痤疮患者的临床研究中，CAB 凝胶显示出优于载体和成分二联体的疗效，具有良好的安全性和耐受性。现将个别临床研究参与者的详细疗效/安全性数据呈现如下。
在两项 3 期（NCT04214652、NCT04214639）随机、双盲、为期 12 周的研究中，年龄至少 9 岁的中重度痤疮患者被随机分配至每日一次 CAB 凝胶或载体凝胶组。从 6 例接受 CAB 治疗的病例中总结了描述性数据，包括皮损计数变化、治疗成功（评估者总体严重程度评分至少降低 2 级，且皮损消退为无/几乎无）、依从性、治疗中出现的不良事件（AE）以及皮肤安全性/耐受性评估。
在第 12 周时，所有病例的皮损减少均超过 70%，4/6 例达到治疗成功，1/6 例达到严重程度降低 2 级。所有病例均对 CAB 治疗依从。无病例报告严重 AE。皮肤安全性/耐受性评估出现短暂的升高，评分通常在第 12 周时下降至/低于基线水平。
在两项 3 期临床试验中，固定剂量的三联组合 CAB 凝胶显示出良好的疗效/安全性。在第 12 周时，所有 6 例接受 CAB 治疗的病例的皮损减少均超过 70%，其中 5/6 例达到治疗成功或严重程度降低 2 级。皮肤安全性/耐受性严重程度的短暂升高通常在第 12 周时恢复至基线值。这些临床研究病例强化了患者教育的重要性，包括对依从性、期望和 AE 的教育。J 皮肤病药物治疗杂志。2024；23（11）：1017-1024. doi：10.36849/JDD.8639.
