DMT310-005 Topical in the Treatment of Acne Rosacea

NCT ID: NCT05108025

Last Updated: 2022-12-08

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-12-31

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 rosacea.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study Treatment 1

DMT310 Powder mixed with Hydrogen Peroxide

Group Type EXPERIMENTAL

Topical Powder

Intervention Type DRUG

Topical Powder mixed with diluent

Study Treatment 2

Placebo powder mixed with Hydrogen Peroxide

Group Type EXPERIMENTAL

Placebo Topical Powder

Intervention Type DRUG

Placebo Topical Powder mixed with diluent

Interventions

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Topical Powder

Topical Powder mixed with diluent

Intervention Type DRUG

Placebo Topical Powder

Placebo Topical Powder mixed with diluent

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 papulopustular acne rosacea as determined by:

Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory 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 rosacea
Minimum Eligible Age

18 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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DMT310-005

Identifier Type: -

Identifier Source: org_study_id

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