Click image to enlargeThe purpose of this study is to compare how effective and well-tolerated by the body the study drug is when given as capsules (2g) compared to placebo (capsules with no active ingredient) in approximately 220 patients with moderate to severe AD. The placebo capsules are made from the same base product used to make the study drug capsules, but do not contain any DGLA. You will be asked to take either the study drug or placebo 2 hours after food at approximately the same time each day. You will also be asked to fast for 1 hour after drug intake.
The study drug has shown potential as an anti-inflammatory drug.
The active ingredient of the study drug is a mixture of free fatty acids synthesised from concentrated natural fatty acids (vegetable origin), containing, principally, dihomo-gamma-linolenic acid (DGLA).
DGLA is an essential fatty acid present in the human diet. DGLA can be found in all human tissues at varying amounts. Literature suggests that DGLA induces (starts or causes) the production of anti-inflammatory molecules known to have beneficial effects in skin diseases
The study will last up to 20 weeks not including the screening period and will involve up to 8 visits to clinic, with one additional telephone visit.