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Completed

NCT Number: NCT03003104

DMT210 Topical Gel in the Treatment of Acne Rosacea

The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.

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Key information

Conditions

Acne Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermata Investigational Site, San Diego, 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 is male or non-pregnant female at least 18 years of age.
  • Clinical diagnosis of moderate to severe facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
  • Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
  • 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 which may affect the patient's rosacea

Treatment and study plan

DMT210 Topical Gel 5%

Drug

Vehicle Control

Other

Primary outcomes

  1. Efficacy as measured by Inflammatory lesion counts

    Time frame: 12 weeks

    Inflammatory lesion counts

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

    Time frame: 12 weeks

    Investigator Global Assessment (IGA)

  3. Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)

    Time frame: 12 weeks

    5-point Clinical Erythema Assessment (CEA)

  4. Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)

    Time frame: 12 weeks

    5-point Patient Severity Assessment of Erythema (PSA)

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 Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 26, 2016
Registry last updated
Apr 18, 2018

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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