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

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ClinicalTrials.gov Identifier: NCT03900676
Recruitment Status : Unknown
Verified September 2019 by Vyome Therapeutics Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 3, 2019
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
Vyome Therapeutics Inc.

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:

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 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 : April 9, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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

Primary Outcome Measures :
  1. Inflammatory lesion counts [ Time Frame: 12 weeks ]
    Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.

Secondary Outcome Measures :
  1. Investigator's Global Assessment of Inflammatory Acne (IGA) score [ Time Frame: 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.

  2. Percent change in inflammatory lesion counts [ Time Frame: 12 weeks ]
    Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900676

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United States, California
Vyome Therapeutics Inc.
Ontario, California, United States, 91762
Vyome Therapeutics Inc.
Sherman Oaks, California, United States, 91403
United States, Florida
Vyome Therapeutics Inc.
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
United States, North Carolina
Vyome Therapeutics Inc.
High Point, North Carolina, United States, 27262
United States, Pennsylvania
Vyome Therapeutics Inc.
Hazleton, Pennsylvania, United States, 18201
Vyome Therapeutics Inc.
Upper Saint Clair, Pennsylvania, United States, 15241
United States, South Carolina
Vyome Therapeutics Inc.
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Vyome Therapeutics Inc.
El Paso, Texas, United States, 79902
Vyome Therapeutics Inc.
El Paso, Texas, United States, 79928
Sponsors and Collaborators
Vyome Therapeutics Inc.
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Study Director: Dr. Shilpi Jain Vyome Therapeutics Inc.
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Responsible Party: Vyome Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03900676    
Other Study ID Numbers: VTI/CR&MA/2019/001
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Do not plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases