Atopic DermatitisPhase 2NCT02211417
Oral DS107 in Moderate to Severe Atopic Dermatitis
A Phase 2 study testing Oral DS107 in people with Atopic Dermatitis, run by Dignity Sciences Ltd. at 14 sites in 2 countries.
Trial summary
This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis. 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Oral DS107
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Jan 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged 18 years and older.
- Moderate to severe atopic dermatitis.
Who cannot join
- Clinically significant impairment of renal or hepatic function.
- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States8 sites
Dignity Sciences investigational site
Arlington Heights, Illinois
Dignity Sciences investigational site
Hazleton, Pennsylvania
Dignity Sciences investigational site
New York, New York
Dignity Sciences investigational site
Philadelphia, Pennsylvania
Dignity Sciences investigational site
Rochester, New York
Dignity Sciences investigational site
Verona, New Jersey
Dignity Sciences investigational site
Warren, Michigan
Dignity Sciences investigational site
West Dundee, Illinois
Canada6 sites
Dignity Sciences investigational site
Calgary, Alberta
Dignity Sciences investigational site
Drummondville, Quebec
Dignity Sciences investigational site
Edmonton, Alberta
Dignity Sciences investigational site
Markham, Ontario
Dignity Sciences investigational site
Montreal, Quebec
Dignity Sciences investigational site
Windsor, Ontario
About this study
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
This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis.
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.
Read the 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).
- Conditions
- Atopic Dermatitis
- Being tested
- Oral DS107, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral DS107Drug
Also called DGLA (Dihomo-gamma-linolenic acid) 500 mg gelatin capsule
PlaceboDrug
Also called Liquid paraffin capsule to mimic Oral DS107 500 mg gelatin capsule
| Study group | Role | What they receive |
|---|---|---|
| Oral DS107 2g | Experimental | Oral DS1072g, 4 x 500mg capsules administered orally once a day Receives: Drug: Oral DS107 |
| Placebo | Placebo comparator | Placebo capsules matching Oral DS107 capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Measured: Week 8
Secondary outcomes (9)
Change From Baseline in IGA at Week 2, 4 and 8.
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Measured: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
- 0 = no symptoms
- 1 = slight
- 2 = moderate
- 3 = marked
A decrease in EASI score indicates a positive outcome for the participant.
Measured: Baseline, Week 2, Week 4 and Week 8
Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
Measured: Up to 8 weeks.
Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale:
- No Days = 0
- 1-2 Days = 1
- 3-4 Days = 2
- 5-6 Days = 3
- Everyday = 4
POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema.
Lower scores on the scale represent a better outcome for the patient.
Measured: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Measured: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.
The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:
- 0 = No symptoms
- 1 = Mild
- 2 = Moderate
- 3 = Severe The overall BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.
Measured: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.
The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.
Measured: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.
One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.
Measured: Baseline, Week 2, Week 4 and Week 8
Number of Participants With TEAEs in Each Treatment Group
Number of participants with at least 1 TEAE.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dignity Sciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Climax, Ph.D., Study chair, Dignity Sciences Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211417
- Sponsor's protocol ID
- DS107G-02
- Status last verified
- Sep 2022
- First submitted
- 5 Aug 2014
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 11227040Kawashima 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.
PubMed 19275928Makrides 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.
PubMed 7762522Teraoka 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.
PubMed 19502748Tanaka 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.
PubMed 22411689
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02211417
- Acronym / sponsor ID
- DS107G-02
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dignity Sciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Posted 7 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral DS107 2g | Experimental | Drug: Oral DS107Oral DS1072g, 4 x 500mg capsules administered orally once a day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules matching Oral DS107 capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subject aged 18 years and older.
- Moderate to severe atopic dermatitis.
Key exclusion criteria (4 listed)
- Clinically significant impairment of renal or hepatic function.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral DS107Also: DGLA (Dihomo-gamma-linolenic acid) 500 mg gelatin capsule | Drug | Oral DS107 2g |
| PlaceboAlso: Liquid paraffin capsule to mimic Oral DS107 500 mg gelatin capsule | Drug | Placebo |
Primary outcome
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.
Time frame: Week 8
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
9 secondary outcomes
Change From Baseline in IGA at Week 2, 4 and 8.
Time frame: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
Time frame: Baseline, Week 2, Week 4 and Week 8
Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.
Time frame: Up to 8 weeks.
Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
Time frame: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
Time frame: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.
Time frame: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.
Time frame: Baseline, Week 2, Week 4 and Week 8
Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.
Time frame: Baseline, Week 2, Week 4 and Week 8
Number of Participants With TEAEs in Each Treatment Group
Time frame: Up to 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11227040Scollan 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.
- Background: PubMed 19275928Kawashima 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.
- Background: PubMed 7762522Makrides 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.
- Background: PubMed 19502748Teraoka 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.
- Background: PubMed 22411689Tanaka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Climax, Ph.D. study chair
Dignity Sciences Ltd.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral DS107 in people with Atopic Dermatitis, run by Dignity Sciences Ltd. at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8. (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02211417, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.