Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2015-01-31
2015-12-31
Brief Summary
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Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against placebo.
This study will enroll approximately 100 adult patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral DS107 2g
Oral DS1072g, 4 x 500mg capsules administered orally once a day
Oral DS107
Placebo
Placebo capsules matching Oral DS107 capsules
Placebo
Interventions
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Oral DS107
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe atopic dermatitis.
Exclusion Criteria
* History of hypersensitivity to any substance in Oral DS107 or placebo capsules.
* Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).
* Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.
18 Years
ALL
No
Sponsors
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Dignity Sciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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John Climax, Ph.D.
Role: STUDY_CHAIR
Dignity Sciences Ltd.
Locations
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Dignity Sciences investigational site
Arlington Heights, Illinois, United States
Dignity Sciences investigational site
West Dundee, Illinois, United States
Dignity Sciences investigational site
Warren, Michigan, United States
Dignity Sciences investigational site
Verona, New Jersey, United States
Dignity Sciences investigational site
New York, New York, United States
Dignity Sciences investigational site
Rochester, New York, United States
Dignity Sciences investigational site
Hazleton, Pennsylvania, United States
Dignity Sciences investigational site
Philadelphia, Pennsylvania, United States
Dignity Sciences investigational site
Calgary, Alberta, Canada
Dignity Sciences investigational site
Edmonton, Alberta, Canada
Dignity Sciences investigational site
Markham, Ontario, Canada
Dignity Sciences investigational site
Windsor, Ontario, Canada
Dignity Sciences investigational site
Drummondville, Quebec, Canada
Dignity Sciences investigational site
Montreal, Quebec, Canada
Countries
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References
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Scollan ND, Choi NJ, Kurt E, Fisher AV, Enser M, Wood JD. Manipulating the fatty acid composition of muscle and adipose tissue in beef cattle. Br J Nutr. 2001 Jan;85(1):115-24. doi: 10.1079/bjn2000223.
Kawashima H, Toyoda-Ono Y, Suwa Y, Kiso Y. Subchronic (13-week) oral toxicity study of dihomo-gamma-linolenic acid (DGLA) oil in rats. Food Chem Toxicol. 2009 Jun;47(6):1280-6. doi: 10.1016/j.fct.2009.03.001. Epub 2009 Mar 9.
Makrides M, Simmer K, Neumann M, Gibson R. Changes in the polyunsaturated fatty acids of breast milk from mothers of full-term infants over 30 wk of lactation. Am J Clin Nutr. 1995 Jun;61(6):1231-3. doi: 10.1093/ajcn/61.6.1231.
Teraoka N, Kawashima H, Shiraishi-Tateishi A, Tanaka T, Nakamura J, Kakutani S, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid-enriched oil altered serum fatty acids in healthy men. Biosci Biotechnol Biochem. 2009 Jun;73(6):1453-5. doi: 10.1271/bbb.90112. Epub 2009 Jun 7.
Tanaka T, Kakutani S, Horikawa C, Kawashima H, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid (DGLA)-enriched oil increases serum DGLA content in healthy adults. Lipids. 2012 Jun;47(6):643-6. doi: 10.1007/s11745-012-3664-3. Epub 2012 Mar 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DS107G-02
Identifier Type: -
Identifier Source: org_study_id
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