DMT310-009 Topical in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A PHASE 3 STUDY OF TOLERABILITY, SAFETY, AND EFFICACY, OF DMT310 IN PATIENTS WITH ACNE VULGARIS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090721
• Other study ID #: DMT310-009
• Status: Recruiting
• Phase: Phase 3
• Start date: December 8, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: December 2023
• Source: Dermata Therapeutics
• Contact: Dermata Study Director
• Phone: (858) 223-0883
• Email: clinicaltrial[@]dermatarx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 555
• Est. completion date: March 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• DMT310
Topical Powder
• Placebo
Placebo Topical Powder

Locations

Country	Name	City	State
United States	DermResearch	Austin	Texas
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California

Sponsors (1)

Lead Sponsor	Collaborator
Dermata Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as measured by lesion counts	Inflammatory and Noninflammatory	12 weeks
Primary	Efficacy as measured by Investigator Global Assessment (IGA)	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	12 weeks
Secondary	Incidence of adverse events as a measure of safety and tolerability	Incidence of adverse events as a measure of safety and tolerability	12 weeks