Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris
NCT ID: NCT03900676
Last Updated: 2019-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
480 participants
INTERVENTIONAL
2019-04-09
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VB-1953 topical gel - 2% QD
VB-1953 topical gel - 2% QD
VB-1953 - 2%
Topical Gel
VB-1953 topical gel - 2% BID
VB-1953 topical gel - 2% BID
VB-1953 - 2%
Topical Gel
VB-1953 topical gel- 0% (Vehicle) QD
VB-1953 topical gel- 0% (Vehicle) QD
VB-1953 - 0% (Vehicle)
Topical Gel
VB-1953 Vehicle
VB-1953 topical gel- 0% (Vehicle) BID
VB-1953 - 0% (Vehicle)
Topical Gel
Interventions
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VB-1953 - 2%
Topical Gel
VB-1953 - 0% (Vehicle)
Topical Gel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
9 Years
45 Years
ALL
No
Sponsors
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Vyome Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Shilpi Jain
Role: STUDY_DIRECTOR
Vyome Therapeutics Inc.
Locations
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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
Countries
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Other Identifiers
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VTI/CR&MA/2019/001
Identifier Type: -
Identifier Source: org_study_id
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