DMT310-001 Topical in the Treatment of Acne Vulgaris

Dermata Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Hydrogen Peroxide; Drug: DMT310; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536637

DMT310-001

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: 121 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is male or non-pregnant female at least 18 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 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 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: Factorial Assignment

Masking: Quadruple Blind

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121 participants in 4 patient groups, including a placebo group

Study Treatment 1

Experimental group

Description:

DMT310 Powder mixed with Hydrogen Peroxide

Treatment:

Drug: DMT310

Drug: Hydrogen Peroxide

Study Treatment 2

Experimental group

Description:

DMT310 Powder mixed with Placebo Diluent

Treatment:

Drug: DMT310

Study Treatment 3

Experimental group

Description:

Placebo powder mixed with Hydrogen Peroxide

Treatment:

Drug: Hydrogen Peroxide

Drug: Placebo

Control

Placebo Comparator group

Description:

Placebo powder mixed with Placebo Diluent

Treatment:

Drug: Placebo