DMT210 Topical Gel in the Treatment of Atopic Dermatitis
1 other identifier
interventional
19
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2016
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2017
CompletedApril 18, 2018
April 1, 2018
10 months
October 27, 2016
April 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ADSI (Atopic Dermatitis Severity Index) score of each Target lesion
Change from baseline in ADSI score between Vehicle and 5% gel
Day 28
Secondary Outcomes (2)
Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion
Day 28
Investigator Global Assessment (IGA) of the Treatment Area
Day 28
Other Outcomes (1)
Incidence of adverse events as a measure of safety and tolerability
Day 28
Study Arms (2)
DMT210 Topical Gel
EXPERIMENTALDMT210 Topical Gel 5% applied to target lesion twice daily
Vehicle Control
PLACEBO COMPARATORTopical Gel vehicle applied to target lesion twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient has used topical therapies for AD within the Treatment Areas 2 weeks before baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dermata Investigational Site
Houston, Texas, 77056, United States
Dermata Investigational Site
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christopher Nardo, PhD
Dermata Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 31, 2016
Study Start
October 1, 2016
Primary Completion
July 14, 2017
Study Completion
July 14, 2017
Last Updated
April 18, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share