Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 1 of 1 for:    DMT310-003 | Recruiting, Not yet recruiting Studies | acne
Previous Study | Return to List | Next Study

DMT310-003 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: NCT04106778
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : November 21, 2019
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: Placebo Phase 2

Layout table for study information
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 Tolerability, Safety, And Efficacy, Of DMT310 In Patients With Acne Vulgaris
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 30, 2020

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

Experimental: Study Treatment 2
Placebo powder mixed with Hydrogen Peroxide
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.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04106778


Contacts
Layout table for location contacts
Contact: Dermata Study Director 858 223-0883 clinicaltrial@dermatarx.com

Locations
Layout table for location information
United States, Texas
Dermata Investigational Site Recruiting
Austin, Texas, United States, 78759
Sponsors and Collaborators
Dermata Therapeutics

Layout table for additonal information
Responsible Party: Dermata Therapeutics
ClinicalTrials.gov Identifier: NCT04106778    
Other Study ID Numbers: DMT310-003
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases