Clinical Trial 43591

Kenosha, WI 53144


Summary:

Study 43591 Flyer
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The 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.


Qualified Participants Must:

• Be 18 years of age or older
• Have been diagnosed with moderate to severe Atopic Dermatitis / Eczema
• Be willing to discontinue current treatments for eczema throughout the study (Except for allowed emollients)


Qualified Participants May Receive:

Study-related, care, investigational medication, and labs at no cost

Compensation for time and travel of $50 for each completed visit


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.