Overview
Efficacy and Steroid Sparing Potential Study of DGLA Cream in Early Childhood Patients With Moderate to Severe Atopic Dermatitis
Status:
Completed
Completed
Trial end date:
2016-04-25
2016-04-25
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis. DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 56 days DS107E or vehicle will be topically administered twice a day. This study will enrol approximately 40 paediatric patients.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
DS BiopharmaTreatments:
Cortisol succinateHydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Criteria
Inclusion Criteria:1. Female and male infants aged 3-12 months.
2. Diagnosis of atopic dermatitis according to the Hanifin and Rajka 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.
7. Patients who have completed the tolerability patch test without any adverse effects
after 72 hours.
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 cream
(including the tolerability patch test performed at the Screening Visit) 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 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).