DMT310-003 Topical in the Treatment of Acne Vulgaris
A Study of Tolerability, Safety, And Efficacy, Of DMT310 In Patients With Acne Vulgaris
1 other identifier
interventional
181
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 27, 2019
CompletedStudy Start
First participant enrolled
October 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2020
CompletedJuly 22, 2020
September 1, 2019
7 months
September 25, 2019
July 20, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy as measured by lesion counts
Inflammatory and Noninflammatory
12 Weeks
Efficacy as measured by Investigator Global Assessment (IGA)
0 None No evidence of facial acne vulgaris 1. Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 4. Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present
12 Weeks
Secondary Outcomes (1)
Incidence of adverse events as a measure of safety and tolerability
12 Weeks
Study Arms (2)
Study Treatment 1
EXPERIMENTALDMT310 Powder mixed with Hydrogen Peroxide
Study Treatment 2
EXPERIMENTALPlacebo powder mixed with Hydrogen Peroxide
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient is pregnant or planning to become pregnant
- Patient is taking a topical therapy on the face which may affect the patient's acne
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dermata Investigational Site
Austin, Texas, 78759, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2019
First Posted
September 27, 2019
Study Start
October 10, 2019
Primary Completion
May 4, 2020
Study Completion
May 4, 2020
Last Updated
July 22, 2020
Record last verified: 2019-09