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Efficacy and Safety of VB-1953 Topical Gel in Non-Responder Acne Patients with Clindamycin-Resistant Cutibacterium acnes.


ABSTRACT: BACKGROUND AND OBJECTIVES: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. METHODS: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. RESULTS: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?

SUBMITTER: Batra R 

PROVIDER: S-EPMC7221013 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Efficacy and Safety of VB-1953 Topical Gel in Non-Responder Acne Patients with Clindamycin-Resistant Cutibacterium acnes.

Batra Rohit R   Sadhasivam Suresh S   Saini Swamini S   Gupta Swati S   Bisen Rahul Kumar Singh RKS   Sinha Mau M   Ghosh Shamik S   Jain Shilpi S  

Drugs in R&D 20200601 2


<h4>Background and objectives</h4>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.<h4>Methods</h4>An investigator-initiated, open label, single-arm clinic  ...[more]

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