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DMT310-005 Topical in the Treatment of Acne Rosacea

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ClinicalTrials.gov Identifier: NCT05108025
Recruitment Status : Recruiting
First Posted : November 4, 2021
Last Update Posted : July 27, 2022
Information provided by (Responsible Party):
Dermata Therapeutics

Brief Summary:
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 rosacea.

Condition or disease Intervention/treatment Phase
Acne Rosacea Drug: Topical Powder Drug: Placebo Topical Powder Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Acne Rosacea

Arm Intervention/treatment
Experimental: Study Treatment 1
DMT310 Powder mixed with Hydrogen Peroxide
Drug: Topical Powder
Topical Powder mixed with diluent

Experimental: Study Treatment 2
Placebo powder mixed with Hydrogen Peroxide
Drug: Placebo Topical Powder
Placebo Topical Powder mixed with diluent

Primary Outcome Measures :
  1. Efficacy as measured by lesion counts [ Time Frame: 12 Weeks ]
    Inflammatory lesion counts

  2. Efficacy as measured by Investigator Global Assessment (IGA) [ Time Frame: 12 Weeks ]

    IGA Scale:

    0 Clear No papules and/or pustules

    1. Almost Clear Rare papules and/or pustules
    2. Mild Few papules and/or pustules
    3. Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules)
    4. Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patient is male or non-pregnant female at least 18 years of age.

Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by:

Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory 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 rosacea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05108025

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Contact: Dermata Study Director 858-800-2543 ext 703 clinicaltrial@dermatarx.com

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United States, Texas
Dermata Investigational Site Recruiting
Austin, Texas, United States, 78759
Sponsors and Collaborators
Dermata Therapeutics
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Responsible Party: Dermata Therapeutics
ClinicalTrials.gov Identifier: NCT05108025    
Other Study ID Numbers: DMT310-005
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases