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Oral DS107G in Moderate to Severe Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02211417
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Dignity Sciences Ltd.

Brief Summary:

This study will compare the safety and efficacy of DS107G (2 g) to placebo in patients with moderate to severe atopic dermatitis.

DS107G capsules (2 g) will be orally administered for 8 weeks, and will be compared against placebo.

This study will enroll approximately 100 adult patients.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: DS107G Drug: Placebo Phase 2

Detailed Description:
Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global Assessment), SCORAD (Scoring Atopic Dermatitis) visual analog scale (VAS)), EASI, BSA (Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality Index), and SCORAD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS107G to Patients With Moderate to Severe Atopic Dermatitis
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: DS107G
DS107G 2g capsules taken by mouth daily for 56 days.
Drug: DS107G
Other Name: DGLA (Dihomo-gamma-linolenic acid) 500 mg gelatin capsule

Placebo Comparator: Placebo
Placebo capsules 2g taken by mouth daily for 56 days.
Drug: Placebo
Other Name: Liquid paraffin capsule to mimic DS107G 500 mg gelatin capsule




Primary Outcome Measures :
  1. IGA (Investigator's Global Assessment) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. IGA (Investigator's Global Assessment) [ Time Frame: 2, 4 and 8 weeks ]
  2. EASI (Eczema Area and Severity Index) [ Time Frame: 2, 4 and 8 weeks ]
  3. POEM (Patient Orientated Eczema Measure) [ Time Frame: 2, 4 and 8 weeks ]
  4. DLQI (Dermatology Life Quality Index) [ Time Frame: 2, 4 and 8 weeks ]
  5. SCORAD (Score Atopic Dermatitis) [ Time Frame: 2, 4 and 8 weeks ]
  6. VAS (visual analog scale) pruritis score [ Time Frame: 2, 4 and 8 weeks ]
  7. BSA (Body surface area) affected [ Time Frame: 2, 4 and 8 weeks ]
  8. TEAE Treatment emergent adverse events [ Time Frame: 10 weeks ]

Other Outcome Measures:
  1. TEWL (Trans epidermal water loss) [ Time Frame: 2, 4 and 8 weeks ]
  2. Plasma total DGLA (dihomo-gamma-linolenic acid) concentrations [ Time Frame: 0, 4 and 8 weeks ]
  3. Plasma freeDGLA (dihomo-gamma-linolenic acid) concentrations [ Time Frame: 0, 4 and 8 weeks ]
  4. Plasma total fatty acid profile [ Time Frame: 0, 4 and 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject aged 18 years and older.
  • Moderate to severe atopic dermatitis.

Exclusion Criteria:

  • Clinically significant impairment of renal or hepatic function.
  • History of hypersensitivity to any substance in DS107G 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211417


Locations
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United States, Illinois
Dignity Sciences investigational site
Arlington Heights, Illinois, United States
Dignity Sciences investigational site
West Dundee, Illinois, United States
United States, Michigan
Dignity Sciences investigational site
Warren, Michigan, United States
United States, New Jersey
Dignity Sciences investigational site
Verona, New Jersey, United States
United States, New York
Dignity Sciences investigational site
New York City, New York, United States
Dignity Sciences investigational site
Rochester, New York, United States
United States, Pennsylvania
Dignity Sciences investigational site
Hazleton, Pennsylvania, United States
Dignity Sciences investigational site
Philadelphia, Pennsylvania, United States
Canada, Alberta
Dignity Sciences investigational site
Calgary, Alberta, Canada
Dignity Sciences investigational site
Edmonton, Alberta, Canada
Canada, Ontario
Dignity Sciences investigational site
Markham, Ontario, Canada
Dignity Sciences investigational site
Windsor, Ontario, Canada
Canada, Quebec
Dignity Sciences investigational site
Drummondville, Quebec, Canada
Dignity Sciences investigational site
Montreal, Quebec, Canada
Sponsors and Collaborators
Dignity Sciences Ltd.
Investigators
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Study Chair: John Climax, Ph.D. Dignity Sciences Ltd.

Publications:
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Responsible Party: Dignity Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02211417     History of Changes
Other Study ID Numbers: DS107G-02
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases