Back to resultsDMT310-005 Topical in the Treatment of Acne Rosacea
Primary Purpose
Acne Rosacea
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topical Powder
Placebo Topical Powder
Sponsored by
About this trial
This is an interventional treatment trial for Acne Rosacea
Eligibility Criteria
Inclusion Criteria:
Patient is male or non-pregnant female at least 18 years of age.
Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by:
Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory 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 rosacea
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 lesion counts
Efficacy as measured by Investigator Global Assessment (IGA)
IGA Scale:
0 Clear No papules and/or pustules
Almost Clear Rare papules and/or pustules
Mild Few papules and/or pustules
Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules)
Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions
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
NCT ID
NCT05108025
First Posted
October 26, 2021
Last Updated
December 7, 2022
Sponsor
Dermata Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT05108025
Brief Title
DMT310-005 Topical in the Treatment of Acne Rosacea
Official Title
A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
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 rosacea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (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)
Topical Powder
Intervention Description
Topical Powder mixed with diluent
Intervention Type
Drug
Intervention Name(s)
Placebo Topical Powder
Intervention Description
Placebo Topical Powder mixed with diluent
Primary Outcome Measure Information:
Title
Efficacy as measured by lesion counts
Description
Inflammatory lesion counts
Time Frame
12 Weeks
Title
Efficacy as measured by Investigator Global Assessment (IGA)
Description
IGA Scale:
0 Clear No papules and/or pustules
Almost Clear Rare papules and/or pustules
Mild Few papules and/or pustules
Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules)
Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions
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
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is male or non-pregnant female at least 18 years of age.
Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by:
Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory 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 rosacea
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
DMT310-005 Topical in the Treatment of Acne Rosacea
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