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

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VB-1953 - 2%
VB-1953 - 0% (Vehicle)
Sponsored by
Vyome Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - 45 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.
  • Vyome Therapeutics Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

VB-1953 topical gel - 2% QD

VB-1953 topical gel - 2% BID

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

VB-1953 Vehicle

Arm Description

VB-1953 topical gel - 2% QD

VB-1953 topical gel - 2% BID

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

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

Outcomes

Primary Outcome Measures

Inflammatory lesion counts
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
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
Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12

Full Information

First Posted
April 1, 2019
Last Updated
September 30, 2019
Sponsor
Vyome Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03900676
Brief Title
Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vyome Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple (Participant, Care Provider, Investigator)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VB-1953 topical gel - 2% QD
Arm Type
Experimental
Arm Description
VB-1953 topical gel - 2% QD
Arm Title
VB-1953 topical gel - 2% BID
Arm Type
Experimental
Arm Description
VB-1953 topical gel - 2% BID
Arm Title
VB-1953 topical gel- 0% (Vehicle) QD
Arm Type
Placebo Comparator
Arm Description
VB-1953 topical gel- 0% (Vehicle) QD
Arm Title
VB-1953 Vehicle
Arm Type
Placebo Comparator
Arm Description
VB-1953 topical gel- 0% (Vehicle) BID
Intervention Type
Drug
Intervention Name(s)
VB-1953 - 2%
Intervention Description
Topical Gel
Intervention Type
Drug
Intervention Name(s)
VB-1953 - 0% (Vehicle)
Intervention Description
Topical Gel
Primary Outcome Measure Information:
Title
Inflammatory lesion counts
Description
Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment of Inflammatory Acne (IGA) score
Description
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.
Time Frame
12 weeks
Title
Percent change in inflammatory lesion counts
Description
Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Shilpi Jain
Organizational Affiliation
Vyome Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Vyome Therapeutics Inc.
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Vyome Therapeutics Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Vyome Therapeutics Inc.
City
El Paso
State/Province
Texas
ZIP/Postal Code
79928
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Do not plan to share IPD.

Learn more about this trial

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

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