Topical treatment for moderate to severe acne vulgaris
A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS
PHASE3 · Dermata Therapeutics · NCT06090721
This study is testing a new topical powder called DMT310 to see if it can help people with moderate to severe acne feel better compared to a placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 555 (estimated) |
| Ages | 9 Years and up |
| Sex | All |
| Sponsor | Dermata Therapeutics (industry) |
| Locations | 2 sites (Fremont, California and 1 other locations) |
| Trial ID | NCT06090721 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of DMT310, a topical powder, in treating moderate to severe facial acne vulgaris in both male and female patients. Participants will be assessed based on their clinical diagnosis and the number of inflammatory and non-inflammatory lesions present. The study involves a comparison between the DMT310 treatment and a placebo to determine its effectiveness in improving acne symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are males and non-pregnant females aged 9 years and older with a clinical diagnosis of moderate to severe acne vulgaris.
Not a fit: Patients who are pregnant or planning to become pregnant, or those currently using topical therapies that may affect their acne, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of moderate to severe acne vulgaris for patients.
How similar studies have performed: Other studies have shown success with topical treatments for acne vulgaris, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient sex at birth, male or non-pregnant female at least 9 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 and 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
Where this trial is running
Fremont, California and 1 other locations
- Center for Dermatology Clinical Research, Inc. — Fremont, California, United States (RECRUITING)
- DermResearch — Austin, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Dermata Study Director
- Email: clinicaltrial@dermatarx.com
- Phone: (858) 223-0883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acne Vulgaris