DMT210 Topical Gel in the Treatment of Acne Rosacea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DMT210 Topical Gel

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

Group Type EXPERIMENTAL

DMT210 Topical Gel 5%

Intervention Type DRUG

Vehicle Control

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

Group Type PLACEBO_COMPARATOR

Vehicle Control

Intervention Type OTHER

Interventions

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DMT210 Topical Gel 5%

Intervention Type DRUG

Vehicle Control

Intervention Type OTHER

Eligibility Criteria

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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