Acne VulgarisPhase 2NCT03900676
Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris
A Phase 2 study testing VB-1953 - 2% in people with Acne Vulgaris, run by Vyome Therapeutics Inc. at 12 sites in United States.
Trial summary
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris, Read more about this study
- Who is it for?
- Ages 9 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- VB-1953 - 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 12 sitesUnited States
- Study dates
- 9 Apr 2019to Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Vyome Therapeutics Inc.
Brandon, Florida, 33511
Vyome Therapeutics Inc.
Coral Gables, Florida, 33134
Vyome Therapeutics Inc.
El Paso, Texas, 79902
Vyome Therapeutics Inc.
El Paso, Texas, 79928
Vyome Therapeutics Inc.
Hazleton, Pennsylvania, 18201
Vyome Therapeutics Inc.
High Point, North Carolina, 27262
Vyome Therapeutics Inc
Miami, Florida, 33126
Vyome Therapeutics Inc.
Mt. Pleasant, South Carolina, 29464
Vyome Therapeutics Inc.
Ontario, California, 91762
Vyome Therapeutics Inc.
Sherman Oaks, California, 91403
Vyome Therapeutics Inc.
Upper Saint Clair, Pennsylvania, 15241
Vyome Therapeutics Inc.
Winter Park, Florida, 32792
About this study
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
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:
- Conditions
- Acne Vulgaris
- Being tested
- VB-1953 - 2%, VB-1953 - 0% (Vehicle)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VB-1953 - 2%Drug
Topical Gel
VB-1953 - 0% (Vehicle)Drug
Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| VB-1953 topical gel - 2% QD | Experimental | VB-1953 topical gel - 2% QD Receives: Drug: VB-1953 - 2% |
| VB-1953 topical gel - 2% BID | Experimental | VB-1953 topical gel - 2% BID Receives: Drug: VB-1953 - 2% |
| VB-1953 topical gel- 0% (Vehicle) QD | Placebo comparator | VB-1953 topical gel- 0% (Vehicle) QD Receives: Drug: VB-1953 - 0% (Vehicle) |
| VB-1953 Vehicle | Placebo comparator | VB-1953 topical gel- 0% (Vehicle) BID Receives: Drug: VB-1953 - 0% (Vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory lesion counts
Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
Percent change in inflammatory lesion counts
Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start9 Apr 2019
- Primary completionNov 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vyome Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Shilpi Jain, Study director, Vyome Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900676
- Sponsor's protocol ID
- VTI/CR&MA/2019/001
- Status last verified
- Sep 2019
- First submitted
- 1 Apr 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Do not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03900676
- Acronym / sponsor ID
- VTI/CR&MA/2019/001
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Vyome Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| VB-1953 topical gel - 2% QD | Experimental | Drug: VB-1953 - 2%VB-1953 topical gel - 2% QD |
| VB-1953 topical gel - 2% BID | Experimental | Drug: VB-1953 - 2%VB-1953 topical gel - 2% BID |
| VB-1953 topical gel- 0% (Vehicle) QD | Placebo comparator | Drug: VB-1953 - 0% (Vehicle)VB-1953 topical gel- 0% (Vehicle) QD |
| VB-1953 Vehicle | Placebo comparator | Drug: VB-1953 - 0% (Vehicle)VB-1953 topical gel- 0% (Vehicle) BID |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VB-1953 - 2%Topical Gel | Drug | VB-1953 topical gel - 2% BID, VB-1953 topical gel - 2% QD |
| VB-1953 - 0% (Vehicle)Topical Gel | Drug | VB-1953 Vehicle, VB-1953 topical gel- 0% (Vehicle) QD |
Primary outcome
Inflammatory lesion counts
Time frame: 12 weeks
Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12.
2 secondary outcomes
Investigator's Global Assessment of Inflammatory Acne (IGA) score
Time frame: 12 weeks
Percent change in inflammatory lesion counts
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No. Do not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Shilpi Jain study director
Vyome Therapeutics Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VB-1953 - 2% in people with Acne Vulgaris, run by Vyome Therapeutics Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory lesion counts (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.