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

Sponsor

Vyome Therapeutics Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03900676

Collaborator

(none)

480

Enrollment

Locations

Arms

10.7

Anticipated Duration (Months)

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: VB-1953 - 2% Drug: VB-1953 - 0% (Vehicle)	Phase 2

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:

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 9, 2019

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VB-1953 topical gel - 2% QD VB-1953 topical gel - 2% QD	Drug: VB-1953 - 2% Topical Gel
Experimental: VB-1953 topical gel - 2% BID VB-1953 topical gel - 2% BID	Drug: VB-1953 - 2% Topical Gel
Placebo Comparator: VB-1953 topical gel- 0% (Vehicle) QD VB-1953 topical gel- 0% (Vehicle) QD	Drug: VB-1953 - 0% (Vehicle) Topical Gel
Placebo Comparator: VB-1953 Vehicle VB-1953 topical gel- 0% (Vehicle) BID	Drug: VB-1953 - 0% (Vehicle) Topical Gel

Outcome Measures

Primary Outcome Measures

Inflammatory lesion counts [12 weeks]
Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.

Secondary Outcome Measures

Investigator's Global Assessment of Inflammatory Acne (IGA) score [12 weeks]
Proportion of subjects achieving success at Week 12, with success defined as Investigator's Global Assessment of Inflammatory Acne (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from Baseline.
Percent change in inflammatory lesion counts [12 weeks]
Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vyome Therapeutics Inc.	Ontario	California	United States	91762
2	Vyome Therapeutics Inc.	Sherman Oaks	California	United States	91403
3	Vyome Therapeutics Inc.	Brandon	Florida	United States	33511
4	Vyome Therapeutics Inc.	Coral Gables	Florida	United States	33134
5	Vyome Therapeutics Inc	Miami	Florida	United States	33126
6	Vyome Therapeutics Inc.	Winter Park	Florida	United States	32792
7	Vyome Therapeutics Inc.	High Point	North Carolina	United States	27262
8	Vyome Therapeutics Inc.	Hazleton	Pennsylvania	United States	18201
9	Vyome Therapeutics Inc.	Upper Saint Clair	Pennsylvania	United States	15241
10	Vyome Therapeutics Inc.	Mount Pleasant	South Carolina	United States	29464
11	Vyome Therapeutics Inc.	El Paso	Texas	United States	79902
12	Vyome Therapeutics Inc.	El Paso	Texas	United States	79928

Sponsors and Collaborators

Vyome Therapeutics Inc.

Investigators

Study Director: Dr. Shilpi Jain, Vyome Therapeutics Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vyome Therapeutics Inc.

ClinicalTrials.gov Identifier:

NCT03900676

Other Study ID Numbers:

VTI/CR&MA/2019/001

First Posted:

Apr 3, 2019

Last Update Posted:

Oct 1, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acne Vulgaris

Study Results

No Results Posted as of Oct 1, 2019