Oral DS107 in Moderate to Severe Atopic Dermatitis

Dignity Sciences

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Oral DS107

Study type: Interventional

Funder types: Industry

Identifiers

NCT02211417

DS107G-02

Details and patient eligibility

About

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.

Full 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 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).

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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102 participants in 2 patient groups, including a placebo group

Oral DS107 2g

Experimental group

Description:

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

Treatment:

Drug: Oral DS107

Placebo

Placebo Comparator group

Description:

Placebo capsules matching Oral DS107 capsules

Treatment:

Drug: Placebo