Clinical trial NCT03900676: Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Vyome Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 480
Sex: ALL
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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

Detailed 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:

Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory lesion counts
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigator's Global Assessment of Inflammatory Acne (IGA) score
timeFrame: 12 weeks
measure: Percent change in inflammatory lesion counts
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ontario
country: United States
facility: Vyome Therapeutics Inc.
state: California
city: Sherman Oaks
country: United States
facility: Vyome Therapeutics Inc.
state: California
city: Brandon
country: United States
facility: Vyome Therapeutics Inc.
state: Florida
city: Coral Gables
country: United States
facility: Vyome Therapeutics Inc.
state: Florida
city: Miami
country: United States
facility: Vyome Therapeutics Inc
state: Florida
city: Winter Park
country: United States
facility: Vyome Therapeutics Inc.
state: Florida
city: High Point
country: United States
facility: Vyome Therapeutics Inc.
state: North Carolina
city: Hazleton
country: United States
facility: Vyome Therapeutics Inc.
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Vyome Therapeutics Inc.
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Vyome Therapeutics Inc.
state: South Carolina
city: El Paso
country: United States
facility: Vyome Therapeutics Inc.
state: Texas
city: El Paso
country: United States
facility: Vyome Therapeutics Inc.
state: Texas
Study officials:
affiliation: Vyome Therapeutics Inc.
name: Dr. Shilpi Jain
role: STUDY_DIRECTOR
References: