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

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

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

Study Overview

• Status: Unknown
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: VB-1953 - 2%; Drug: VB-1953 - 0% (Vehicle)

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 Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Ontario, California, United States, 91762
      • Vyome Therapeutics Inc.
    • Sherman Oaks, California, United States, 91403
      • Vyome Therapeutics Inc.
  • Florida
    • Brandon, Florida, United States, 33511
      • Vyome Therapeutics Inc.
    • Coral Gables, Florida, United States, 33134
      • Vyome Therapeutics Inc.
    • Miami, Florida, United States, 33126
      • Vyome Therapeutics Inc
    • Winter Park, Florida, United States, 32792
      • Vyome Therapeutics Inc.
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Vyome Therapeutics Inc.
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • Vyome Therapeutics Inc.
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • Vyome Therapeutics Inc.
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Vyome Therapeutics Inc.
  • Texas
    • El Paso, Texas, United States, 79902
      • Vyome Therapeutics Inc.
    • El Paso, Texas, United States, 79928
      • Vyome Therapeutics Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VB-1953 topical gel - 2% QD	Drug: VB-1953 - 2%; Topical Gel
Experimental: VB-1953 topical gel - 2% BID	Drug: VB-1953 - 2%; Topical Gel
Placebo Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory lesion counts	Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
Percent change in inflammatory lesion counts	Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12	12 weeks

Collaborators and Investigators

• Sponsor: Vyome Therapeutics Inc.
• Investigators: Study Director: Dr. Shilpi Jain, Vyome Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: VTI/CR&MA/2019/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Do not plan to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No