DMT210 Topical Gel in the Treatment of Acne Rosacea

Acne Rosacea Clinical Trial

Official title:

A Randomized, Double-Blind, Vehicle Controlled Study To Evaluate The Safety, Tolerability, And Efficacy Of DMT210 Gel In Adult Patients With Moderate To Severe Acne Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003104
• Other study ID #: DMT210-003
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2016
• Last updated: April 17, 2018
• Start date: January 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: April 2018
• Source: Dermata Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates the safety, tolerability, and efficacy of DMT210 Gel, 5% when applied twice daily for 12 weeks in adult patients with moderate to severe acne rosacea. Half of participants will receive DMT210 Gel while the other half will receive vehicle control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• 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 facial rosacea as determined by Investigator's Global Assessment (IGA) at Randomization

• Patient has at least ten inflammatory lesions of rosacea on the face at Randomization

• 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 which may affect the patient's rosacea

Related Conditions & MeSH terms

• Acne Rosacea
• Rosacea

Intervention

Drug:
• DMT210 Topical Gel 5%

Other:
• Vehicle Control

Locations

Country	Name	City	State
United States	Dermata Investigational Site	Austin	Texas
United States	Dermata Investigational Site	Broomall	Pennsylvania
United States	Dermata Investigational Site	Fridley	Minnesota
United States	Dermata Investigational Site	High Point	North Carolina
United States	Dermata Investigational Site	Miami	Florida
United States	Dermata Investigational Site	Nashville	Tennessee
United States	Dermata Investigational Site	Norfolk	Virginia
United States	Dermata Investigational Site	Omaha	Nebraska
United States	Dermata Investigational Site	San Diego	California

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 Inflammatory lesion counts	Inflammatory lesion counts	12 weeks
Primary	Efficacy as measured by Investigator Global Assessment (IGA)	Investigator Global Assessment (IGA)	12 weeks
Primary	Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)	5-point Clinical Erythema Assessment (CEA)	12 weeks
Primary	Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)	5-point Patient Severity Assessment of Erythema (PSA)	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