DMT310-005 Topical in the Treatment of Acne Rosacea

NCT05108025 | Unknown Phase 2 FDA Drug

• 1 other identifier: DMT310-005
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Rosacea

Outcome Measures

Primary Outcomes (2)

• Efficacy as measured by lesion counts

  Inflammatory lesion counts

  12 Weeks

• Efficacy as measured by Investigator Global Assessment (IGA)

  IGA Scale: 0 Clear No papules and/or pustules 1. Almost Clear Rare papules and/or pustules 2. Mild Few papules and/or pustules 3. Moderate Pronounced number of papules and/or pustules (but less than numerous papules and/or pustules) 4. Severe Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions

  12 Weeks

Secondary Outcomes (1)

• Incidence of adverse events as a measure of safety and tolerability

  12 Weeks

Study Arms (2)

Study Treatment 1

EXPERIMENTAL

DMT310 Powder mixed with Hydrogen Peroxide

Drug: Topical Powder

Study Treatment 2

EXPERIMENTAL

Placebo powder mixed with Hydrogen Peroxide

Drug: Placebo Topical Powder

Interventions

Topical Powder DRUG

Topical Powder mixed with diluent

Study Treatment 1

Placebo Topical Powder DRUG

Placebo Topical Powder mixed with diluent

Study Treatment 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face which may affect the patient's rosacea

Sponsors & Collaborators

• Dermata Therapeutics: lead

Study Sites (1)

Dermata Investigational Site

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Powders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 4, 2021
• Study Start: November 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

US (1)