DMT210 Topical Gel in the Treatment of Acne Rosacea

Dermata Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acne Rosacea

Treatments: Drug: DMT210 Topical Gel 5%; Other: Vehicle Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT03003104

DMT210-003

Details and patient eligibility

About

The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.

Enrollment: 107 patients

Sex: All

Ages: 18+ 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 facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization
• Patient has at least ten inflammatory lesions of rosacea on the face at Randomization
• 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 which may affect the patient's rosacea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 2 patient groups, including a placebo group

DMT210 Topical Gel

Experimental group

Description:

DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks

Treatment:

Drug: DMT210 Topical Gel 5%

Vehicle Control

Placebo Comparator group

Description:

Topical Gel vehicle applied to the face twice daily for 12 weeks

Treatment:

Other: Vehicle Control