NCT03900676

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 9, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

April 1, 2019

Last Update Submit

September 30, 2019

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Inflammatory lesion counts

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

    12 weeks

Secondary Outcomes (2)

  • Investigator's Global Assessment of Inflammatory Acne (IGA) score

    12 weeks

  • Percent change in inflammatory lesion counts

    12 weeks

Study Arms (4)

VB-1953 topical gel - 2% QD

EXPERIMENTAL

VB-1953 topical gel - 2% QD

Drug: VB-1953 - 2%

VB-1953 topical gel - 2% BID

EXPERIMENTAL

VB-1953 topical gel - 2% BID

Drug: VB-1953 - 2%

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

PLACEBO COMPARATOR

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

Drug: VB-1953 - 0% (Vehicle)

VB-1953 Vehicle

PLACEBO COMPARATOR

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

Drug: VB-1953 - 0% (Vehicle)

Interventions

VB-1953 - 2%DRUG

Topical Gel

VB-1953 topical gel - 2% BIDVB-1953 topical gel - 2% QD
VB-1953 - 0% (Vehicle)DRUG

Topical Gel

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

Eligibility Criteria

Age9 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Vyome Therapeutics Inc.

Ontario, California, 91762, United States

Location

Vyome Therapeutics Inc.

Sherman Oaks, California, 91403, United States

Location

Vyome Therapeutics Inc.

Brandon, Florida, 33511, United States

Location

Vyome Therapeutics Inc.

Coral Gables, Florida, 33134, United States

Location

Vyome Therapeutics Inc

Miami, Florida, 33126, United States

Location

Vyome Therapeutics Inc.

Winter Park, Florida, 32792, United States

Location

Vyome Therapeutics Inc.

High Point, North Carolina, 27262, United States

Location

Vyome Therapeutics Inc.

Hazleton, Pennsylvania, 18201, United States

Location

Vyome Therapeutics Inc.

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Vyome Therapeutics Inc.

Mt. Pleasant, South Carolina, 29464, United States

Location

Vyome Therapeutics Inc.

El Paso, Texas, 79902, United States

Location

Vyome Therapeutics Inc.

El Paso, Texas, 79928, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

VB-1953

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Dr. Shilpi Jain

    Vyome Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Triple (Participant, Care Provider, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

April 9, 2019

Primary Completion

November 1, 2019

Study Completion

March 1, 2020

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Do not plan to share IPD.

Locations

US(12)