DMT310-003 Topical in the Treatment of Acne Vulgaris

• Sponsor: Dermata Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04106778
• Collaborator: (none)
• Enrollment: 181
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.8
• Patients Per Site Per Month: 26.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: DMT310; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 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: Oct 10, 2019
• Actual Primary Completion Date: May 4, 2020
• Actual Study Completion Date: May 4, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Efficacy as measured by lesion counts [12 Weeks]

   Inflammatory and Noninflammatory

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

   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

Secondary Outcome Measures

1. Incidence of adverse events as a measure of safety and tolerability [12 Weeks]

   Incidence of adverse events as a measure of safety and tolerability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermata Investigational Site	Austin	Texas	United States	78759

Sponsors and Collaborators

• Dermata Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dermata Therapeutics
• ClinicalTrials.gov Identifier: NCT04106778
• Other Study ID Numbers: DMT310-003
• First Posted: Sep 27, 2019
• Last Update Posted: Jul 22, 2020
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

No Results Posted as of Jul 22, 2020