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

Vyome Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: VB-1953 - 2%; Drug: VB-1953 - 0% (Vehicle)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03900676

VTI/CR&MA/2019/001

Details and patient eligibility

About

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

Full 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:

Enrollment: 480 estimated patients

Sex: All

Ages: 9 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 4 patient groups, including a placebo group

VB-1953 topical gel - 2% QD

Experimental group

Description:

VB-1953 topical gel - 2% QD

Treatment:

Drug: VB-1953 - 2%

VB-1953 topical gel - 2% BID

Experimental group

Description:

VB-1953 topical gel - 2% BID

Treatment:

Drug: VB-1953 - 2%

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

Placebo Comparator group

Description:

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

Treatment:

Drug: VB-1953 - 0% (Vehicle)

VB-1953 Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: VB-1953 - 0% (Vehicle)