DMT310-001 Topical in the Treatment of Acne Vulgaris

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

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-22

Study Completion Date

2019-01-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study Treatment 1

DMT310 Powder mixed with Hydrogen Peroxide

Group Type EXPERIMENTAL

DMT310

Intervention Type DRUG

Topical Powder

Hydrogen Peroxide

Intervention Type DRUG

Liquid Diluent

Study Treatment 2

DMT310 Powder mixed with Placebo Diluent

Group Type EXPERIMENTAL

DMT310

Intervention Type DRUG

Topical Powder

Study Treatment 3

Placebo powder mixed with Hydrogen Peroxide

Group Type EXPERIMENTAL

Hydrogen Peroxide

Intervention Type DRUG

Liquid Diluent

Placebo

Intervention Type DRUG

Placebo Topical Powder

Control

Placebo powder mixed with Placebo Diluent

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Topical Powder

Interventions

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DMT310

Topical Powder

Intervention Type DRUG

Hydrogen Peroxide

Liquid Diluent

Intervention Type DRUG

Placebo

Placebo Topical Powder

Intervention Type DRUG

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 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