DMT210 Topical Gel in the Treatment of Acne Rosacea

• Sponsor: Dermata Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03003104
• Collaborator: (none)
• Enrollment: 107
• Locations: 9
• Arms: 2
• Duration (Months): 7.9
• Patients Per Site: 11.9
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acne Rosacea	Drug: DMT210 Topical Gel 5%; Other: Vehicle Control	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Aug 30, 2017
• Actual Study Completion Date: Aug 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DMT210 Topical Gel DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks	Drug: DMT210 Topical Gel 5%
Placebo Comparator: Vehicle Control Topical Gel vehicle applied to the face twice daily for 12 weeks	Other: Vehicle Control

Outcome Measures

Primary Outcome Measures

1. Efficacy as measured by Inflammatory lesion counts [12 weeks]

   Inflammatory lesion counts

2. Efficacy as measured by Investigator Global Assessment (IGA) [12 weeks]

   Investigator Global Assessment (IGA)

3. Efficacy as measured by 5-point Clinical Erythema Assessment (CEA) [12 weeks]

   5-point Clinical Erythema Assessment (CEA)

4. Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA) [12 weeks]

   5-point Patient Severity Assessment of Erythema (PSA)

Secondary Outcome Measures

1. 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: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermata Investigational Site	San Diego	California	United States
2	Dermata Investigational Site	Miami	Florida	United States
3	Dermata Investigational Site	Fridley	Minnesota	United States
4	Dermata Investigational Site	Omaha	Nebraska	United States
5	Dermata Investigational Site	High Point	North Carolina	United States
6	Dermata Investigational Site	Broomall	Pennsylvania	United States
7	Dermata Investigational Site	Nashville	Tennessee	United States
8	Dermata Investigational Site	Austin	Texas	United States
9	Dermata Investigational Site	Norfolk	Virginia	United States

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: NCT03003104
• Other Study ID Numbers: DMT210-003
• First Posted: Dec 26, 2016
• Last Update Posted: Apr 18, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dermata Therapeutics: Skin diseases; rosacea
• Additional relevant MeSH terms: Rosacea

Study Results

No Results Posted as of Apr 18, 2018