Efficacy and Steroid Sparing Potential Study of DGLA Cream in Patients With Moderate to Severe Atopic Dermatitis

This is an interventional treatment trial for Atopic Dermatitis Read More

Inclusion Criteria:

• Female and male volunteers aged 18-65 who are willing to give written informed consent.
• Diagnosis of atopic dermatitis (> 6 months) according to the Hanifin and Raika Criteria;
• Presence of at least 2 moderate to severe (target lesion score</=8) inflammatory lesions of comparable severity, erythema >/= 2
• Patients with moderate to severe atopic dermatitis (IGA=3-4)
• A body surface area score of less than 20%

Exclusion Criteria:

• Clinically significant impairment of renal or hepatic function.
• Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).
• History of intolerance to any ingredient in DS107E DGLA cream or Vehicle or intolerance to any ingredient in Ecural®(Mometasone furoate 0.1%). Of note, any intolerance to PHB ester (benzoate, parabens) or soy or it's cross-allergen peanut, as these are ingredients of DS107E.
• Use of biologics 3 months prior to start of treatment/ Day 0 visit (baseline), or 5 half-lives (whichever is longer).
• Use of systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed.
• Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline), or 5 half lives (whichever is longer).
• Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to Day 0 visit (baseline) and/or is planning a trip to sunny climate or to use tanning booths or other UV sources between screening and follow-up visits.
• 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.
• Use of topical products containing ceramides 2 weeks prior to Day 0. Topical products that do not contain ceramides are allowed.
• Use of anti-histamines for atopic dermatitis within 2 weeks of baseline.
• Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).
• History of clinically significant drug or alcohol abuse in the last year prior to Day 0 (baseline).