DMT310-003 Topical in the Treatment of Acne Vulgaris

Dermata Therapeutics181 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

181

Conditions

Acne Vulgaris

Interventions

DMT310DRUG

Topical Powder

PlaceboDRUG

Placebo Topical Powder

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Dermata Investigational Site

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 None No evidence of facial acne vulgaris 1. Minimal Few noninflammatory lesions (comedones) are present; a few inflammatory lesions(papules/pustules) may be present; no nodulo-cystic lesions are allowed) 2. Mild Several to many noninflammatory lesions (comedones) are present; a few inflammatory lesions (papules/pustules) are present; no nodulo-cystic lesions are allowed 3. Moderate Many noninflammatory (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

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