ClinicalTrials.gov
ClinicalTrials.gov Menu

DMT310-001 Topical in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03536637
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : June 12, 2018
Sponsor:
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 vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: DMT310 Drug: Hydrogen Peroxide Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : February 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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

Drug: Hydrogen Peroxide
Liquid Diluent

Experimental: Study Treatment 2
DMT310 Powder mixed with Placebo Diluent
Drug: DMT310
Topical Powder

Experimental: Study Treatment 3
Placebo powder mixed with Hydrogen Peroxide
Drug: Hydrogen Peroxide
Liquid Diluent

Drug: Placebo
Placebo Topical Powder

Placebo Comparator: Control
Placebo powder mixed with Placebo Diluent
Drug: Placebo
Placebo Topical Powder




Primary Outcome Measures :
  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

    1. Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed)
    2. Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
    3. Moderate Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed
    4. 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 :
  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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Patient is male or non-pregnant female at least 18 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 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 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

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): NCT03536637


Contacts
Contact: Dermata Study Director 858 228-0880 clinicaltrial@dermatarx.com

Locations
United States, California
Dermata Investigational Site Recruiting
San Diego, California, United States, 92123
United States, Missouri
Dermata Investigational Site Recruiting
Saint Joseph, Missouri, United States, 64506
United States, Nevada
Dermata Investigational Site Recruiting
Henderson, Nevada, United States, 89148
United States, New Mexico
Dermata Investigational Site Recruiting
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Dermata Investigational Site Recruiting
High Point, North Carolina, United States, 27262
United States, Tennessee
Dermata Investigational Site Recruiting
Tennessee, Tennessee, United States, 37215
United States, Texas
Dermata Investigational Site Recruiting
Austin, Texas, United States, 78759
Dermata Investigational Site Recruiting
College Station, Texas, United States, 77802
Dermata Investigational Site Recruiting
Katy, Texas, United States, 77494
Sponsors and Collaborators
Dermata Therapeutics

Responsible Party: Dermata Therapeutics
ClinicalTrials.gov Identifier: NCT03536637     History of Changes
Other Study ID Numbers: DMT310-001
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Hydrogen Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents