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 will be compared against placebo. This study will enroll approximately 100 adult patients.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

102

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach

2 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

August 5, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed

5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

6.9 years until next milestone

Results Posted

Study results publicly available

October 7, 2022

Completed

Last Updated

October 7, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

August 5, 2014

Results QC Date

August 3, 2022

Last Update Submit

September 9, 2022

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Week 8

Secondary Outcomes (9)

Change From Baseline in IGA at Week 2, 4 and 8.
Baseline, Week 2, Week 4 and Week 8
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
Baseline, Week 2, Week 4 and Week 8
Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.
Up to 8 weeks.
Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
Baseline, Week 2, Week 4 and Week 8
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
Baseline, Week 2, Week 4 and Week 8
+4 more secondary outcomes

Study Arms (2)

Oral DS107 2g

EXPERIMENTAL

Oral DS1072g, 4 x 500mg capsules administered orally once a day

Drug: Oral DS107

Placebo

PLACEBO COMPARATOR

Placebo capsules matching Oral DS107 capsules

Drug: Placebo

Interventions

Oral DS107DRUG

Also known as: DGLA (Dihomo-gamma-linolenic acid) 500 mg gelatin capsule

Oral DS107 2g

PlaceboDRUG

Also known as: Liquid paraffin capsule to mimic Oral DS107 500 mg gelatin capsule

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subject aged 18 years and older.
Moderate to severe atopic dermatitis.

You may not qualify if:

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.

Contact the study team to confirm eligibility.