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DMT310-009 Topical in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DMT310
Placebo
Sponsored by
Dermata Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    DMT310 Topical Powder

    Placebo Topical Powder

    Arm Description

    DMT310 Powder mixed with Hydrogen Peroxide

    Placebo powder mixed with Hydrogen Peroxide

    Outcomes

    Primary Outcome Measures

    Efficacy as measured by lesion counts
    Inflammatory and Noninflammatory
    Efficacy as measured by Investigator Global Assessment (IGA)
    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 Outcome Measures

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

    Full Information

    First Posted
    October 13, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Dermata Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06090721
    Brief Title
    DMT310-009 Topical in the Treatment of Acne Vulgaris
    Official Title
    A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Dermata Therapeutics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 vulgaris

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    555 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DMT310 Topical Powder
    Arm Type
    Experimental
    Arm Description
    DMT310 Powder mixed with Hydrogen Peroxide
    Arm Title
    Placebo Topical Powder
    Arm Type
    Experimental
    Arm Description
    Placebo powder mixed with Hydrogen Peroxide
    Intervention Type
    Drug
    Intervention Name(s)
    DMT310
    Intervention Description
    Topical Powder
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo Topical Powder
    Primary Outcome Measure Information:
    Title
    Efficacy as measured by lesion counts
    Description
    Inflammatory and Noninflammatory
    Time Frame
    12 weeks
    Title
    Efficacy as measured by Investigator Global Assessment (IGA)
    Description
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events as a measure of safety and tolerability
    Description
    Incidence of adverse events as a measure of safety and tolerability
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dermata Study Director
    Phone
    (858) 223-0883
    Email
    clinicaltrial@dermatarx.com

    12. IPD Sharing Statement

    Learn more about this trial

    DMT310-009 Topical in the Treatment of Acne Vulgaris

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