DMT310-001 Topical in the Treatment of Acne Vulgaris

A Study of Tolerability, Safety, And Efficacy, of DMT310 In Patients With Acne Vulgaris

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: DMT310; Drug: Hydrogen Peroxide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as measured by lesion counts	Inflammatory and Noninflammatory	12 weeks
Efficacy as measured by Investigator Global Assessment (IGA)	0 None No evidence of facial acne vulgaris; Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed); Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed; Moderate Many noninflammatory (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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events as a measure of safety and tolerability	Incidence of adverse events as a measure of safety and tolerability	12 weeks

Collaborators and Investigators

• Sponsor: Dermata Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2018
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): January 28, 2019

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (ACTUAL): May 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: DMT310-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No