Trial | NCT03900676  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    480
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,
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:
Study Started
Apr 09
2019
Primary Completion
Nov 30
2019
Anticipated
Study Completion
Mar 31
2020
Anticipated
Last Update
Oct 01
2019

Drug VB-1953 - 2%

Topical Gel

Drug VB-1953 - 0% (Vehicle)

Topical Gel

VB-1953 topical gel - 2% QD Experimental

VB-1953 topical gel - 2% QD

VB-1953 topical gel - 2% BID Experimental

VB-1953 topical gel - 2% BID

VB-1953 topical gel- 0% (Vehicle) QD Placebo Comparator

VB-1953 topical gel- 0% (Vehicle) QD

VB-1953 Vehicle Placebo Comparator

VB-1953 topical gel- 0% (Vehicle) BID

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.
No Results Posted