Dermaworld Skin and Hair Clinic, New Delhi, India.
Vyome Therapeutics Limited, Delhi, India.
Drugs R D. 2020 Jun;20(2):95-104. doi: 10.1007/s40268-020-00299-z.
The emergence of resistant strains of Cutibacterium acnes can limit the efficacy of currently approved antibiotics for acne. VB-1953 is a next-generation antibiotic that exerts a bactericidal effect on resistant C. acnes. In this study, we investigated the safety, tolerability, and efficacy of VB-1953 topical gel in patients with moderate to severe acne having clindamycin-resistant C. acnes.
An investigator-initiated, open label, single-arm clinical study was conducted in patients with moderate to severe facial acne vulgaris showing poor or no response to previous clindamycin treatment. Nineteen subjects were enrolled in the study based on laboratory screening for the presence of clindamycin-resistant C. acnes in acne swab samples collected from patients. VB-1953 2% gel was applied on the entire face twice daily over 12 weeks. The primary efficacy endpoints were absolute changes in inflammatory and noninflammatory lesion counts from baseline at week 12, while the secondary efficacy endpoint was the proportion of subjects achieving Investigator Global Assessment success (score of 0 or 1) or a grade 2 or higher improvement from baseline at week 12. The presence and severity of local skin reactions (erythema, edema, scaling/dryness, burning/stinging, pruritus) were evaluated for safety. Additionally, the detection and quantification of drug-resistant C. acnes strains were performed in the laboratory using acne swab samples collected from patients.
The occurrence of treatment-emergent adverse events or changes in vital signs, physical examinations, and urinalysis for any of the patients during the course of the entire study were clinically insignificant. Topical application of 2% VB-1953 topical gel resulted in a significant reduction of mean absolute inflammatory and noninflammatory lesion counts by 53.1% and 52.2%, respectively (p < 0.0001 for both), with an Investigator Global Assessment success of 26.3% at week 12 compared with baseline. Resistant bacteria were reduced by (94.3 ± 1%; p < 0.05) within 12 weeks of treatment with VB-1953.
These results indicate that VB-1953 topical gel can be a safe and effective therapy for moderate to severe acne with underlying resistant C. acnes in subjects who had not responded to previous antibiotic treatments.
痤疮丙酸杆菌耐药株的出现可能会限制目前批准用于痤疮的抗生素的疗效。VB-1953 是一种具有杀菌作用的下一代抗生素，可作用于耐药性痤疮丙酸杆菌。本研究旨在评估 VB-1953 局部凝胶在克林霉素耐药的痤疮丙酸杆菌所致中重度痤疮患者中的安全性、耐受性和疗效。
本研究为研究者发起的、开放性、单臂临床研究，纳入了既往克林霉素治疗效果差或无效的中重度面部寻常性痤疮患者。根据患者痤疮拭子样本中是否存在克林霉素耐药的痤疮丙酸杆菌进行实验室筛查，19 例患者入组本研究。患者每天早晚两次将 VB-1953 2%凝胶涂抹于整个面部，共治疗 12 周。主要疗效终点为治疗 12 周时炎症性和非炎症性皮损计数与基线相比的绝对变化，次要疗效终点为治疗 12 周时达到研究者总体评估（评分 0 或 1）或自基线改善 2 级或更高级别的患者比例。评估局部皮肤反应（红斑、水肿、脱屑/干燥、灼热/刺痛、瘙痒）的发生和严重程度。此外，还使用患者痤疮拭子样本在实验室中检测和定量耐药性痤疮丙酸杆菌菌株。
在整个研究过程中，没有任何患者出现治疗相关的不良事件或生命体征、体格检查和尿液分析的变化，这些变化均具有临床意义。与基线相比，2% VB-1953 局部凝胶治疗后，患者的平均炎症性和非炎症性皮损计数分别显著减少了 53.1%和 52.2%（p 值均<0.0001），治疗 12 周时，研究者总体评估成功率为 26.3%。与基线相比，治疗 12 周时，耐药菌减少了（94.3±1%；p<0.05）。
这些结果表明，VB-1953 局部凝胶可作为一种安全有效的治疗方案，用于治疗既往抗生素治疗无效的中重度、伴有潜在耐药性痤疮丙酸杆菌的寻常性痤疮。
