Status:
COMPLETED
Oral DS107 in Moderate to Severe Atopic Dermatitis
Lead Sponsor:
Dignity Sciences Ltd.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis. Oral DS107 (2 g) will be orally administered for 8 weeks, and wil...
Detailed Description
Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable will be the ...
Eligibility Criteria
Inclusion
- Male or female subject aged 18 years and older.
- Moderate to severe atopic dermatitis.
Exclusion
- Clinically significant impairment of renal or hepatic function.
- History of hypersensitivity to any substance in Oral DS107 or placebo capsules.
- Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).
- Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT02211417
Start Date
January 1 2015
End Date
December 1 2015
Last Update
October 7 2022
Active Locations (14)
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1
Dignity Sciences investigational site
Arlington Heights, Illinois, United States
2
Dignity Sciences investigational site
West Dundee, Illinois, United States
3
Dignity Sciences investigational site
Warren, Michigan, United States
4
Dignity Sciences investigational site
Verona, New Jersey, United States