A Study of DGLA Cream in early childhood patients with atopic dermatitis - inflammatory skin disease.

Phase 1

• Conditions: atopic dermatitis; MedDRA version: 18.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002838-46-IE
• Lead Sponsor: DS Biopharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-09
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Female and male infants aged 3-12 months.
2. Diagnosis of atopic dermatitis according to the Hanifin and Raika Criteria.
3. Patients with moderate to severe atopic dermatitis (IGA =3)
4. Patients with atopic dermatitis covering a minimum of 10% of the body surface area at baseline.
5. Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.
6. The patient's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 63 days.

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any clinically significant controlled or uncontrolled medical condition that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results.
2. Clinically significant impairment of renal or hepatic function.
3. Clinically significant immunodeficiency.
4. Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).
5. Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).
6. History of intolerance to any ingredient in DS107E DGLA cream or Vehicle or intolerance to any ingredient in Locoid® Ointment (hydrocortisone butyrate 0.1%).
7. Use of systemic treatments that could affect atopic dermatitis less than 4 weeks prior to Baseline Visit (Day 0), e.g. oral corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed.
8. Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline), or 5 half-lives (whichever is longer).
9. Excessive sun exposure or other ultraviolet (UV) light sources 4 weeks prior to Day 0 Visit (Baseline) and/or is planning a trip to sunny climate or other UV sources between screening and follow-up visits.
10. Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of treatment/Day 0 Visit (Baseline), including but not limited to emollients, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
11. Use of topical products containing ceramides 2 weeks prior to Day 0.
12. Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified