DMT310-005 Topical in the Treatment of Acne Rosacea

Acne Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05108025
• Other study ID #: DMT310-005
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 15, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: Dermata Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Rosacea
• Rosacea

Intervention

Drug:
• Topical Powder
Topical Powder mixed with diluent
• Placebo Topical Powder
Placebo Topical Powder mixed with diluent

Locations

Country	Name	City	State
United States	Dermata Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dermata Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as measured by lesion counts	Inflammatory lesion counts	12 Weeks
Primary	Efficacy as measured by Investigator Global Assessment (IGA)	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	12 Weeks
Secondary	Incidence of adverse events as a measure of safety and tolerability	Incidence of adverse events as a measure of safety and tolerability	12 Weeks