DMT310-003 Topical in the Treatment of Acne Vulgaris

NCT ID: NCT04106778

Last Updated: 2020-07-22

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

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-10

Study Completion Date

2020-05-04

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.

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Study Treatment 2

Placebo powder mixed with Hydrogen Peroxide

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo Topical Powder

Interventions

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DMT310

Topical Powder

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 12 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 inflammatory lesions on the face Patient has at least 20 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dermata Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dermata Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DMT310-003

Identifier Type: -

Identifier Source: org_study_id

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