DMT210 Topical Gel in the Treatment of Acne Rosacea

Phase 2

Completed

• Conditions: Acne Rosacea
• Interventions: Drug: DMT210 Topical Gel 5%; Other: Vehicle Control

• Registration Number: NCT03003104
• Lead Sponsor: Dermata Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Study Start: 2017-01
• Primary Completion: 2017-08-30
• Study Completion: 2017-08-30
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

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Exclusion Criteria

• Patient is pregnant or planning to become pregnant
• Patient is taking a topical therapy which may affect the patient's rosacea

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMT210 Topical Gel	DMT210 Topical Gel 5%	DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks
Vehicle Control	Vehicle Control	Topical Gel vehicle applied to the face twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy as measured by Inflammatory lesion counts	12 weeks	Inflammatory lesion counts
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)	12 weeks	5-point Clinical Erythema Assessment (CEA)
Efficacy as measured by Investigator Global Assessment (IGA)	12 weeks	Investigator Global Assessment (IGA)
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)	12 weeks	5-point Patient Severity Assessment of Erythema (PSA)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events as a measure of safety and tolerability	12 weeks	Incidence of adverse events as a measure of safety and tolerability

Trial Locations

Locations (1)

Dermata Investigational Site; 🇺🇸 Norfolk, Virginia, United States