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Status unknownNCT03900676Updated Oct 1, 2019

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

A Phase 2 interventional study of VB-1953 - 2% and VB-1953 - 0% (Vehicle) in Acne Vulgaris, sponsored by Vyome Therapeutics Inc.. Status unknown at 12 sites in United States. Open to participants aged 9 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by Vyome Therapeutics Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
9 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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:

02

Conditions studied

  • Acne Vulgaris

Browse trials for

03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's planned enrollment of 480 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

This is the only study on the registry with Vyome Therapeutics Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
480 participants (estimated)

Study arms

  • Experimental
    VB-1953 topical gel - 2% QD

    VB-1953 topical gel - 2% QD

    Drug: VB-1953 - 2%

  • Experimental
    VB-1953 topical gel - 2% BID

    VB-1953 topical gel - 2% BID

    Drug: VB-1953 - 2%

  • Placebo comparator
    VB-1953 topical gel- 0% (Vehicle) QD

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

    Drug: VB-1953 - 0% (Vehicle)

  • Placebo comparator
    VB-1953 Vehicle

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

    Drug: VB-1953 - 0% (Vehicle)

Interventions

  • DrugVB-1953 - 2%

    Topical Gel

  • DrugVB-1953 - 0% (Vehicle)

    Topical Gel

06

What researchers measure

Primary outcomes

  1. Inflammatory lesion counts

    Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. Percent change in inflammatory lesion counts

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

    Time frame: 12 weeks

07

Study locations

12 sites
  • Vyome Therapeutics Inc.
    Ontario, California 91762, United States
  • Vyome Therapeutics Inc.
    Sherman Oaks, California 91403, United States
  • Vyome Therapeutics Inc.
    Brandon, Florida 33511, United States
  • Vyome Therapeutics Inc.
    Coral Gables, Florida 33134, United States
  • Vyome Therapeutics Inc
    Miami, Florida 33126, United States
  • Vyome Therapeutics Inc.
    Winter Park, Florida 32792, United States
  • Vyome Therapeutics Inc.
    High Point, North Carolina 27262, United States
  • Vyome Therapeutics Inc.
    Hazleton, Pennsylvania 18201, United States
  • Vyome Therapeutics Inc.
    Upper Saint Clair, Pennsylvania 15241, United States
  • Vyome Therapeutics Inc.
    Mount Pleasant, South Carolina 29464, United States
  • Vyome Therapeutics Inc.
    El Paso, Texas 79902, United States
  • Vyome Therapeutics Inc.
    El Paso, Texas 79928, United States
08

References and documents

Individual participant data

Plan to share: No — Do not plan to share IPD.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03900676
Lead sponsor
Vyome Therapeutics Inc.
Responsible party
Sponsor
First posted
Apr 3, 2019
Start date
Apr 9, 2019
Primary completion
Nov 2019 (estimated)
Completion
Mar 2020 (estimated)
Last update
Oct 1, 2019

Study contacts

Dr. Shilpi Jain
study director · Vyome Therapeutics Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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