DMT310-009 Topical in the Treatment of Acne Vulgaris

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06090721

Enrollment

520

Registered

2023-10-19

Start date

2023-12-08

Completion date

2025-04-30

Last updated

2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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

Interventions

DRUGDMT310

Topical Powder

DRUGPlacebo

Placebo Topical Powder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

9 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy as measured by lesion counts	12 weeks	Inflammatory and Noninflammatory
Efficacy as measured by Investigator Global Assessment (IGA)	12 weeks	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

Secondary

Measure	Time frame	Description
Incidence of adverse events as a measure of safety and tolerability	12 weeks	Incidence of adverse events as a measure of safety and tolerability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026