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DMT310 Topical Powder 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy as measured by Investigator Global Assessment (IGA)

Efficacy as measured by lesion counts

Secondary outcome measures

Incidence of adverse events as a measure of safety and tolerability

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

Placebo

1995

Completed Phase 3

~2670

DMT310

2019

Completed Phase 2

~310

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dermata TherapeuticsLead Sponsor

5 Previous Clinical Trials

608 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently accepting new participants?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking eligible participants. The initial posting of the study took place on December 8th, 2023 and the most recent update occurred on December 15th, 2023. This particular study aims to enroll a total of 555 individuals across two distinct locations."

Answered by AI

What is the current number of individuals actively engaged in this clinical study?

"Indeed, the details on clinicaltrials.gov confirm that this trial is actively seeking eligible participants. The study's initial posting was on December 8th, 2023 and it was last updated on December 15th, 2023. To complete the trial successfully, a total of 555 patients will be recruited from two designated sites."

Answered by AI

Are there any potential risks or adverse effects associated with the use of DMT310 Topical Powder in patients?

"Our team at Power rates the safety of DMT310 Topical Powder as a 3 on a scale from 1 to 3. This rating is based on the fact that it is currently in Phase 3 clinical trial, indicating that there is existing data supporting its efficacy and multiple rounds of data demonstrating its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DMT310-009 Topical in the Treatment of Acne Vulgaris

2023. "DMT310-009 Topical in the Treatment of Acne Vulgaris". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06090721.

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