Back to resultsDMT210 Topical Gel in the Treatment of Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DMT210 Topical Gel
Vehicle Control
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Eczema, Dermatitis, Skin Diseases, Skin Diseases, Genetic, Dermatitis, Atopic, Skin Diseases, Eczematous, Hypersensitivity, Immune System Diseases
Eligibility Criteria
Inclusion Criteria:
- Male or female 12 years or older
- Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement
- Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas
- Patient is willing and able to comply with the protocol
Exclusion Criteria:
- Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline
Sites / Locations
- 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 target lesion twice daily
Topical Gel vehicle applied to target lesion twice daily
Outcomes
Primary Outcome Measures
ADSI (Atopic Dermatitis Severity Index) score of each Target lesion
Change from baseline in ADSI score between Vehicle and 5% gel
Secondary Outcome Measures
Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion
Change from baseline in AD symptom scores between Vehicle and 5% gel
Investigator Global Assessment (IGA) of the Treatment Area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02949960
Brief Title
DMT210 Topical Gel in the Treatment of Atopic Dermatitis
Official Title
DMT210 Topical Gel in the Treatment of Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 14, 2017 (Actual)
Study Completion Date
July 14, 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 objective of the study is to evaluate the safety and efficacy of DMT210 Gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (AD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Eczema, Dermatitis, Skin Diseases, Skin Diseases, Genetic, Dermatitis, Atopic, Skin Diseases, Eczematous, Hypersensitivity, Immune System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DMT210 Topical Gel
Arm Type
Experimental
Arm Description
DMT210 Topical Gel 5% applied to target lesion twice daily
Arm Title
Vehicle Control
Arm Type
Placebo Comparator
Arm Description
Topical Gel vehicle applied to target lesion twice daily
Intervention Type
Drug
Intervention Name(s)
DMT210 Topical Gel
Intervention Description
DMT210 Topical Aqueous Gel 5% applied twice daily
Intervention Type
Drug
Intervention Name(s)
Vehicle Control
Intervention Description
Topical Vehicle Gel applied twice daily
Primary Outcome Measure Information:
Title
ADSI (Atopic Dermatitis Severity Index) score of each Target lesion
Description
Change from baseline in ADSI score between Vehicle and 5% gel
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion
Description
Change from baseline in AD symptom scores between Vehicle and 5% gel
Time Frame
Day 28
Title
Investigator Global Assessment (IGA) of the Treatment Area
Time Frame
Day 28
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events as a measure of safety and tolerability
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 12 years or older
Patient has chronic, stable AD that has been present for at least 3 months with 5-35% (inclusive) BSA (Body Surface Area) of AD involvement
Patient has two analogous, Target Lesions; one lesion within each of the two Treatment Areas
Patient is willing and able to comply with the protocol
Exclusion Criteria:
Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Nardo, PhD
Organizational Affiliation
Dermata Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Dermata Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Dermata Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
DMT210 Topical Gel in the Treatment of Atopic Dermatitis
We'll reach out to this number within 24 hrs