Back to resultsDMT310-003 Topical in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DMT310
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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
Sites / Locations
- Dermata Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study Treatment 1
Study Treatment 2
Arm Description
DMT310 Powder mixed with Hydrogen Peroxide
Placebo powder mixed with Hydrogen Peroxide
Outcomes
Primary Outcome Measures
Efficacy as measured by lesion counts
Inflammatory and Noninflammatory
Efficacy as measured by Investigator Global Assessment (IGA)
0 None No evidence of facial acne vulgaris
Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed)
Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present
Secondary Outcome Measures
Incidence of adverse events as a measure of safety and tolerability
Incidence of adverse events as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04106778
Brief Title
DMT310-003 Topical in the Treatment of Acne Vulgaris
Official Title
A Study of Tolerability, Safety, And Efficacy, Of DMT310 In Patients With Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
May 4, 2020 (Actual)
Study Completion Date
May 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermata Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Treatment 1
Arm Type
Experimental
Arm Description
DMT310 Powder mixed with Hydrogen Peroxide
Arm Title
Study Treatment 2
Arm Type
Experimental
Arm Description
Placebo powder mixed with Hydrogen Peroxide
Intervention Type
Drug
Intervention Name(s)
DMT310
Intervention Description
Topical Powder
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Topical Powder
Primary Outcome Measure Information:
Title
Efficacy as measured by lesion counts
Description
Inflammatory and Noninflammatory
Time Frame
12 Weeks
Title
Efficacy as measured by Investigator Global Assessment (IGA)
Description
0 None No evidence of facial acne vulgaris
Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed)
Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events as a measure of safety and tolerability
Description
Incidence of adverse events as a measure of safety and tolerability
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dermata Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
DMT310-003 Topical in the Treatment of Acne Vulgaris
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