DMT310-009 Topical in the Treatment of Acne Vulgaris

Dermata Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: DMT310; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06090721

DMT310-009

Details and patient eligibility

About

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

Enrollment: 555 estimated patients

Sex: All

Ages: 9+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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555 participants in 2 patient groups

DMT310 Topical Powder

Experimental group

Description:

DMT310 Powder mixed with Hydrogen Peroxide

Treatment:

Drug: DMT310

Placebo Topical Powder

Experimental group

Description:

Placebo powder mixed with Hydrogen Peroxide

Treatment:

Drug: Placebo