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Topical DMT310 for Acne

Phase 3
Recruiting
Research Sponsored by Dermata Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient sex at birth, male or non-pregnant female at least 9 years of age
Investigator's Global Assessment (IGA) at Randomization; Patient has at least 20 inflammatory lesions and at least 20 noninflammatory lesions on the face
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial aims to test a new treatment for people with moderate to severe acne on their face. The trial will assess how well the treatment works and how safe it is for both men and women.

Who is the study for?
This trial is for males and non-pregnant females aged 9 or older with moderate to severe facial acne. Participants must have at least 20 inflammatory and 20 noninflammatory lesions on their face, be willing to apply the treatment as directed, and follow the study rules.
What is being tested?
The trial is testing DMT310, a topical powder mixed with diluent against a placebo (a substance with no active drug) to see if it's safe, tolerable, and effective in treating facial acne vulgaris.
What are the potential side effects?
Possible side effects of DMT310 may include skin irritation, dryness, redness or peeling where the product is applied. Since it's a topical treatment, systemic side effects are less common but can still occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a male or a non-pregnant female aged 9 or older.
Select...
I have at least 20 inflamed and 20 non-inflamed facial lesions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy as measured by Investigator Global Assessment (IGA)
Efficacy as measured by lesion counts
Secondary study objectives
Incidence of adverse events as a measure of safety and tolerability

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo Topical PowderExperimental Treatment1 Intervention
Placebo powder mixed with Hydrogen Peroxide
Group II: DMT310 Topical PowderExperimental Treatment1 Intervention
DMT310 Powder mixed with Hydrogen Peroxide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DMT310
2019
Completed Phase 2
~310
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Dermata TherapeuticsLead Sponsor
5 Previous Clinical Trials
608 Total Patients Enrolled
2 Trials studying Acne Vulgaris
302 Patients Enrolled for Acne Vulgaris
~85 spots leftby Jan 2025
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