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OpenTrials
Completed

NCT Number: NCT06090721

DMT310-009 Topical in the Treatment of Acne Vulgaris

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Dermatology Clinical Research, Inc., Freemont, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMT310

Drug

Topical Powder

Placebo

Drug

Placebo Topical Powder

Primary outcomes

  1. Efficacy as measured by lesion counts

    Time frame: 12 weeks

    Inflammatory and Noninflammatory

  2. Efficacy as measured by Investigator Global Assessment (IGA)

    Time frame: 12 weeks

    0 Clear No evidence of facial acne vulgaris

    • Almost Clear Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed)
    • Mild Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
    • Moderate Many non-inflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
    • Severe Significant degree of inflammatory disease; papules/pustules are a predominant feature; a few nodulo-cystic lesions may be present; comedones may be present

Secondary outcomes

  1. Incidence of adverse events as a measure of safety and tolerability

    Time frame: 12 weeks

    Incidence of adverse events as a measure of safety and tolerability

Sponsors and collaborators

Lead sponsor

Dermata Therapeutics

Industry

Registry information

Official study title

A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 19, 2023
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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