Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 2, Randomized, Multicenter, Double-blind, Vehicle-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of VB-1953 Topical Gel When Applied Once or Twice Daily for 12 Weeks in Subjects With Moderate to Severe Inflammatory Facial Acne Vulgaris

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03900676
• Other study ID #: VTI/CR&MA/2019/001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 9, 2019
• Est. completion date: March 2020

Study information

• Verified date: September 2019
• Source: Vyome Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,

Description:

This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 480
• Est. completion date: March 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 45 Years

Eligibility

Inclusion Criteria:

• Males or non-pregnant females 9 to 45 years of age (inclusive) at the time of consent/assent.

• Have a clinical diagnosis of moderate to severe (Grade 3 or 4) facial acne vulgaris, as determined by the Investigator's Global Assessment (IGA).

• Have 20 to 50 inflammatory lesions (papules, pustules) on the face.

• Have 20 to 60 non-inflammatory lesions on the face.

Exclusion Criteria:

• Has more than two (2) facial nodulocystic lesions.

• Female subject is pregnant, lactating, or is planning to become pregnant during the study.

• Has active nodulocystic acne or acne conglobata, acne fulminans, or other forms of acne (e.g., acne mechanica). In the opinion of the Investigator, the subject has a skin pathology or other medical condition that is clinically significant (e.g., obesity) and will preclude participation in the study.

• Has presence of any skin condition on the face (e.g., rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acnetiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) in the opinion of the Investigator that could interfere with the diagnosis or assessment of acne vulgaris or evaluation of the investigational product (IP) or requires the use of interfering topical or systemic therapy.

• Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• VB-1953 - 2%
Topical Gel
• VB-1953 - 0% (Vehicle)
Topical Gel

Locations

Country	Name	City	State
United States	Vyome Therapeutics Inc.	Brandon	Florida
United States	Vyome Therapeutics Inc.	Coral Gables	Florida
United States	Vyome Therapeutics Inc.	El Paso	Texas
United States	Vyome Therapeutics Inc.	El Paso	Texas
United States	Vyome Therapeutics Inc.	Hazleton	Pennsylvania
United States	Vyome Therapeutics Inc.	High Point	North Carolina
United States	Vyome Therapeutics Inc	Miami	Florida
United States	Vyome Therapeutics Inc.	Mount Pleasant	South Carolina
United States	Vyome Therapeutics Inc.	Ontario	California
United States	Vyome Therapeutics Inc.	Sherman Oaks	California
United States	Vyome Therapeutics Inc.	Upper Saint Clair	Pennsylvania
United States	Vyome Therapeutics Inc.	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vyome Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory lesion counts	Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.	12 weeks
Secondary	Investigator's Global Assessment of Inflammatory Acne (IGA) score	Proportion of subjects achieving success at Week 12, with success defined as Investigator's Global Assessment of Inflammatory Acne (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from Baseline.	12 weeks
Secondary	Percent change in inflammatory lesion counts	Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12	12 weeks