DMT310-005 Topical in the Treatment of Acne Rosacea

Sponsor

Dermata Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05108025

Collaborator

(none)

180

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

15.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Rosacea	Drug: Topical Powder Drug: Placebo Topical Powder	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Study Of The Tolerability, Safety, And Efficacy Of DMT310 For The Treatment Of Acne Rosacea

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Treatment 1 DMT310 Powder mixed with Hydrogen Peroxide	Drug: Topical Powder Topical Powder mixed with diluent
Experimental: Study Treatment 2 Placebo powder mixed with Hydrogen Peroxide	Drug: Placebo Topical Powder Placebo Topical Powder mixed with diluent

Arm

Intervention/Treatment

Experimental: Study Treatment 1

DMT310 Powder mixed with Hydrogen Peroxide

Drug: Topical Powder

Topical Powder mixed with diluent

Experimental: Study Treatment 2

Placebo powder mixed with Hydrogen Peroxide

Drug: Placebo Topical Powder

Placebo Topical Powder mixed with diluent

Outcome Measures

Primary Outcome Measures

Efficacy as measured by lesion counts [12 Weeks]
Inflammatory lesion counts
Efficacy as measured by Investigator Global Assessment (IGA) [12 Weeks]
IGA Scale: 0 Clear No papules and/or pustules Almost Clear Rare papules and/or pustules Mild Few papules and/or pustules Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules) Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions

Secondary Outcome Measures

Incidence of adverse events as a measure of safety and tolerability [12 Weeks]
Incidence of adverse events as a measure of safety and tolerability

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermata Investigational Site	Austin	Texas	United States	78759

Sponsors and Collaborators

Dermata Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dermata Therapeutics

ClinicalTrials.gov Identifier:

NCT05108025

Other Study ID Numbers:

DMT310-005

First Posted:

Nov 4, 2021

Last Update Posted:

Jul 27, 2022

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rosacea

Study Results

No Results Posted as of Jul 27, 2022