DMT310-009 Topical in the Treatment of Acne Vulgaris

Dermata Therapeutics520 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

520

Conditions

Acne Vulgaris

Interventions

DMT310DRUG

Topical Powder

PlaceboDRUG

Placebo Topical Powder

Eligibility

Sex: ALLMin age: 9 Years

Medical Language ↔ Plain English

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

Locations (2)

Center for Dermatology Clinical Research, Inc.

Freemont, California, United States

DermResearch

Austin, Texas, United States

Outcomes

Primary Outcomes

Efficacy as measured by lesion counts

Inflammatory and Noninflammatory

Time frame: 12 weeks

Efficacy as measured by Investigator Global Assessment (IGA)

0 Clear No evidence of facial acne vulgaris 1. Almost Clear Few non-inflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many non-inflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many non-inflammatory (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

Time frame: 12 weeks

Secondary Outcomes

Incidence of adverse events as a measure of safety and tolerability

Time frame: 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.