Back to resultsDMT210 Topical Gel in the Treatment of Acne Rosacea
Primary Purpose
Acne Rosacea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DMT210 Topical Gel 5%
Vehicle Control
Sponsored by
About this trial
This is an interventional treatment trial for Acne Rosacea focused on measuring Skin diseases, rosacea
Eligibility Criteria
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
Sites / Locations
- Dermata Investigational Site
- Dermata Investigational Site
- Dermata Investigational Site
- Dermata Investigational Site
- Dermata Investigational Site
- Dermata Investigational Site
- Dermata Investigational Site
- Dermata Investigational Site
- Dermata Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DMT210 Topical Gel
Vehicle Control
Arm Description
DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks
Topical Gel vehicle applied to the face twice daily for 12 weeks
Outcomes
Primary Outcome Measures
Efficacy as measured by Inflammatory lesion counts
Inflammatory lesion counts
Efficacy as measured by Investigator Global Assessment (IGA)
Investigator Global Assessment (IGA)
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
5-point Clinical Erythema Assessment (CEA)
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
5-point Patient Severity Assessment of Erythema (PSA)
Secondary Outcome Measures
Incidence of adverse events as a measure of safety and tolerability
Incidence of adverse events as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03003104
Brief Title
DMT210 Topical Gel in the Treatment of Acne Rosacea
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermata Therapeutics
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Rosacea
Keywords
Skin diseases, rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DMT210 Topical Gel
Arm Type
Experimental
Arm Description
DMT210 Topical Gel 5% applied to the face twice daily for 12 weeks
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Topical Gel vehicle applied to the face twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
DMT210 Topical Gel 5%
Intervention Type
Other
Intervention Name(s)
Vehicle Control
Primary Outcome Measure Information:
Title
Efficacy as measured by Inflammatory lesion counts
Description
Inflammatory lesion counts
Time Frame
12 weeks
Title
Efficacy as measured by Investigator Global Assessment (IGA)
Description
Investigator Global Assessment (IGA)
Time Frame
12 weeks
Title
Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)
Description
5-point Clinical Erythema Assessment (CEA)
Time Frame
12 weeks
Title
Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)
Description
5-point Patient Severity Assessment of Erythema (PSA)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events as a measure of safety and tolerability
Description
Incidence of adverse events as a measure of safety and tolerability
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dermata Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Dermata Investigational Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Dermata Investigational Site
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
Dermata Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Dermata Investigational Site
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Dermata Investigational Site
City
Broomall
State/Province
Pennsylvania
Country
United States
Facility Name
Dermata Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Dermata Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Dermata Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DMT210 Topical Gel in the Treatment of Acne Rosacea
We'll reach out to this number within 24 hrs