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

Status unconfirmed · Phase 2

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT03900676

Run by

Vyome Therapeutics Inc.

People needed

480

Starts

2019-04-09

Expected to finish

2020-03-01

Last updated by the study team

2019-10-01

Who can join

Age: 9 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vyome Therapeutics Inc. — Ontario, California, United States
• Vyome Therapeutics Inc. — Sherman Oaks, California, United States
• Vyome Therapeutics Inc. — Brandon, Florida, United States
• Vyome Therapeutics Inc. — Coral Gables, Florida, United States
• Vyome Therapeutics Inc — Miami, Florida, United States
• Vyome Therapeutics Inc. — Winter Park, Florida, United States
• Vyome Therapeutics Inc. — High Point, North Carolina, United States
• Vyome Therapeutics Inc. — Hazleton, Pennsylvania, United States
• Vyome Therapeutics Inc. — Upper Saint Clair, Pennsylvania, United States
• Vyome Therapeutics Inc. — Mt. Pleasant, South Carolina, United States
• Vyome Therapeutics Inc. — El Paso, Texas, United States
• Vyome Therapeutics Inc. — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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