Oral DS107G in Moderate to Severe Atopic Dermatitis
| Status: | Completed |
|---|---|
| Conditions: | Psoriasis, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | December 2015 |
A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS107G to Patients With Moderate to Severe Atopic Dermatitis
This study will compare the safety and efficacy of DS107G (2 g) to placebo in patients with
moderate to severe atopic dermatitis.
DS107G capsules (2 g) will be orally administered for 8 weeks, and will be compared against
placebo.
This study will enroll approximately 100 adult patients.
moderate to severe atopic dermatitis.
DS107G capsules (2 g) will be orally administered for 8 weeks, and will be compared against
placebo.
This study will enroll approximately 100 adult patients.
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 IGA. Secondary efficacy variables will include IGA (Investigator's
Global Assessment), SCORAD (Scoring Atopic Dermatitis) visual analog scale (VAS)), EASI, BSA
(Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life
Quality Index), and SCORAD.
week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy
variable will be the IGA. Secondary efficacy variables will include IGA (Investigator's
Global Assessment), SCORAD (Scoring Atopic Dermatitis) visual analog scale (VAS)), EASI, BSA
(Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life
Quality Index), and SCORAD.
Inclusion Criteria:
- Male or female subject aged 18 years and older.
- Moderate to severe atopic dermatitis.
Exclusion Criteria:
- Clinically significant impairment of renal or hepatic function.
- History of hypersensitivity to any substance in DS107G 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.
We found this trial at
9
sites
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