- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04106778
DMT310-003 Topical in the Treatment of Acne Vulgaris
July 20, 2020 updated by: Dermata Therapeutics
A Study of Tolerability, Safety, And Efficacy, Of DMT310 In Patients With Acne Vulgaris
The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris.
Study Overview
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78759
- Dermata Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inclusion Criteria:
- Patient is male or non-pregnant female at least 12 years of age.
- Clinical diagnosis of moderate to severe acne vulgaris as determined by:
Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 inflammatory lesions on the face Patient has at least 20 noninflammatory lesions on the face
- Patient is willing to apply the Investigational Product as directed
- Patient is willing and able to comply with the protocol
Exclusion Criteria:
- Patient is pregnant or planning to become pregnant
- Patient is taking a topical therapy on the face which may affect the patient's acne
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study Treatment 1
DMT310 Powder mixed with Hydrogen Peroxide
|
Topical Powder
|
Experimental: Study Treatment 2
Placebo powder mixed with Hydrogen Peroxide
|
Placebo Topical Powder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy as measured by lesion counts
Time Frame: 12 Weeks
|
Inflammatory and Noninflammatory
|
12 Weeks
|
Efficacy as measured by Investigator Global Assessment (IGA)
Time Frame: 12 Weeks
|
0 None No evidence of facial acne vulgaris
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events as a measure of safety and tolerability
Time Frame: 12 Weeks
|
Incidence of adverse events as a measure of safety and tolerability
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2019
Primary Completion (Actual)
May 4, 2020
Study Completion (Actual)
May 4, 2020
Study Registration Dates
First Submitted
September 25, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (Actual)
September 27, 2019
Study Record Updates
Last Update Posted (Actual)
July 22, 2020
Last Update Submitted That Met QC Criteria
July 20, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMT310-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
-
Nexgen Dermatologics, Inc.Unknown
-
Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Rejuva Medical AestheticsHealMD, LLCNot yet recruitingAcne Vulgaris (Disorder)United States
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingModerate to Severe Acne VulgarisChina
-
PollogenLumenis Be Ltd.RecruitingModerate to Severe Acne VulgarisUnited States
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
Clinical Trials on DMT310
-
Dermata TherapeuticsRecruiting
-
Dermata TherapeuticsCompleted