DMT310-009 Topical in the Treatment of Acne Vulgaris

• Sponsor: Dermata Therapeutics (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06090721
• Collaborator: (none)
• Enrollment: 555
• Arms: 2
• Anticipated Duration (Months): 12

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 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 555 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DMT310 Topical Powder DMT310 Powder mixed with Hydrogen Peroxide	Drug: DMT310; Topical Powder
Experimental: Placebo Topical Powder 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 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

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

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

Contacts and Locations

Locations

No locations specified.

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: NCT06090721
• Other Study ID Numbers: DMT310-009
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• 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 Oct 19, 2023