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OpenTrials
Completed

NCT Number: NCT04106778

DMT310-003 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

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermata Investigational Site

Austin, Texas, 78759, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion Criteria:
  • 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

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 None No evidence of facial acne vulgaris

    • Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed)
    • Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
    • Moderate Many noninflammatory (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 Study of Tolerability, Safety, And Efficacy, Of DMT310 In Patients With Acne Vulgaris

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2019
Registry last updated
Jul 22, 2020

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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