Atopic DermatitisPhase 2NCT03676933
Efficacy and Steroid Sparing Potential Study of DGLA Cream in Early Childhood Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing DS107E and Hydrocortisone Butyrate 0.1% Cream in people with Atopic Dermatitis, run by DS Biopharma at 1 site in Ireland.
Trial summary
This study will investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis. DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 56 days DS107E or vehicle will be topically administered twice a day. Read more about this study
- Who is it for?
- Ages 3 to 12 months
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- DS107E and Hydrocortisone Butyrate 0.1% Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2015to 25 Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 3 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Female and male infants aged 3-12 months.
- Diagnosis of atopic dermatitis according to the Hanifin and Rajka Criteria.
- Patients with moderate to severe atopic dermatitis (IGA ≥3)
- Patients with atopic dermatitis covering a minimum of 10% of the body surface area at baseline.
- Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.
- The patient's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 63 days.
- Patients who have completed the tolerability patch test without any adverse effects after 72 hours.
Who cannot join
- Any clinically significant controlled or uncontrolled medical condition that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results.
- Clinically significant impairment of renal or hepatic function.
- Clinically significant immunodeficiency.
- Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).
- Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).
- History of intolerance to any ingredient in DS107E DGLA cream or Vehicle cream (including the tolerability patch test performed at the Screening Visit) or intolerance to any ingredient in Locoid® Ointment (hydrocortisone butyrate 0.1%).
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- Use of systemic treatments that could affect atopic dermatitis less than 4 weeks prior to Baseline Visit (Day 0), e.g. oral corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed.
- Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline), or 5 half-lives (whichever is longer).
- Excessive sun exposure or other ultraviolet (UV) light sources 4 weeks prior to Day 0 Visit (Baseline) and/or is planning a trip to sunny climate or other UV sources between screening and follow-up visits.
- Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of treatment/Day 0 Visit (Baseline), including but not limited to topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
- Use of topical products containing ceramides 2 weeks prior to Day 0.
- Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised, Vehicle-Controlled, Double-Blind, Exploratory Clinical Trial To Assess The Efficacy And Steroid Sparing Potential Of DGLA Cream Topically Applied To Early Childhood Patients With Moderate To Severe Atopic Dermatitis
This study will investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis.
DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 56 days DS107E or vehicle will be topically administered twice a day.
This study will enrol approximately 40 paediatric patients.
Read the detailed description
Patients will come to the clinic on 8 occasions: Screening, Baseline, Day 7, Day 21, Day 35, Day 49, Day 63 (End of Treatment) and Day 91 (Follow-up). The primary efficacy variables will be IGA (Investigator Global Assessment) and SCORAD (SCORing Atopic Dermatitis) .
The secondary efficacy variables will be IGA, SCORAD, EASI (Eczema Area and Severity Index), IDQOL (Infant Dermatology Quality of Life), DFI (Dermatitis Family Impact), BSA, TEWL (Transepidermal Water Loss) and Time to Rescue Medication.
- Conditions
- Atopic Dermatitis
- Being tested
- DS107E, Vehicle, Hydrocortisone Butyrate 0.1% Cream
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS107EDrug
VehicleDrug
Hydrocortisone Butyrate 0.1% CreamDrug
Steroid taken topically once a day
| Study group | Role | What they receive |
|---|---|---|
| DS107E and Steroid | Experimental | First 7 days: Steroid taken topically once a day and DS107E taken once a day Next 56 days: DS107E taken topically twice a day Receives: Drug: DS107E; Drug: Hydrocortisone Butyrate 0.1% Cream |
| Vehicle and Steroid | Placebo comparator | First 7 days: Steroid taken topically once a day and DS107E taken once a day Next 56 days: DS107E taken topically twice a day Receives: Drug: Vehicle; Drug: Hydrocortisone Butyrate 0.1% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment
Measured: 9 weeks
SCORing Atopic Dermatitis
Erythema, population, oozing, excoriation, lichenification, dryness, body surface area, sleep loss and pruritus is all graded. The sum of the above measures represent the SCORAD which can vary from 0 to 103.
Measured: 9 weeks
Secondary outcomes (5)
Investigator Global Assessment
Measured: Days 7, 21. 35. 49, 63
Eczema Area and Severity Index
Proportion of patients achieving a reduction in EASI score
Measured: Days 7, 21. 35. 49, 63
Body Surface Area
Measured: Days 7, 21. 35. 49, 63
Trans-Epidermal Water Loss
Measured: Days 63
Time to Rescue Medication
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study startOct 2015
- Primary completionApr 2016
- Study completion25 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- DS Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676933
- Sponsor's protocol ID
- DS107E-05
- Status last verified
- Jan 2019
- First submitted
- 30 Jan 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Vehicle-Controlled, Double-Blind, Exploratory Clinical Trial To Assess The Efficacy And Steroid Sparing Potential Of DGLA Cream Topically Applied To Early Childhood Patients With Moderate To Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03676933
- Acronym / sponsor ID
- DS107E-05
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- DS BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- 25 Apr 2016 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
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 investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis.
DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 56 days DS107E or vehicle will be topically administered twice a day.
This study will enrol approximately 40 paediatric patients.
Detailed description
Patients will come to the clinic on 8 occasions: Screening, Baseline, Day 7, Day 21, Day 35, Day 49, Day 63 (End of Treatment) and Day 91 (Follow-up). The primary efficacy variables will be IGA (Investigator Global Assessment) and SCORAD (SCORing Atopic Dermatitis) .
The secondary efficacy variables will be IGA, SCORAD, EASI (Eczema Area and Severity Index), IDQOL (Infant Dermatology Quality of Life), DFI (Dermatitis Family Impact), BSA, TEWL (Transepidermal Water Loss) and Time to Rescue Medication.
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 |
|---|---|---|
| DS107E and Steroid | Experimental | Drug: DS107E, Drug: Hydrocortisone Butyrate 0.1% CreamFirst 7 days: Steroid taken topically once a day and DS107E taken once a day Next 56 days: DS107E taken topically twice a day |
| Vehicle and Steroid | Placebo comparator | Drug: Vehicle, Drug: Hydrocortisone Butyrate 0.1% CreamFirst 7 days: Steroid taken topically once a day and DS107E taken once a day Next 56 days: DS107E taken topically twice a day |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Female and male infants aged 3-12 months.
- Diagnosis of atopic dermatitis according to the Hanifin and Rajka Criteria.
- Patients with moderate to severe atopic dermatitis (IGA ≥3)
- Patients with atopic dermatitis covering a minimum of 10% of the body surface area at baseline.
- Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.
Key exclusion criteria (12 listed)
- Any clinically significant controlled or uncontrolled medical condition that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results.
- Clinically significant impairment of renal or hepatic function.
- Clinically significant immunodeficiency.
- Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).
- Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).
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 |
|---|---|---|
| DS107E | Drug | DS107E and Steroid |
| Vehicle | Drug | Vehicle and Steroid |
| Hydrocortisone Butyrate 0.1% CreamSteroid taken topically once a day | Drug | DS107E and Steroid, Vehicle and Steroid |
Primary outcome
Investigator Global Assessment
Time frame: 9 weeks
SCORing Atopic Dermatitis
Time frame: 9 weeks
Erythema, population, oozing, excoriation, lichenification, dryness, body surface area, sleep loss and pruritus is all graded. The sum of the above measures represent the SCORAD which can vary from 0 to 103.
5 secondary outcomes
Investigator Global Assessment
Time frame: Days 7, 21. 35. 49, 63
Eczema Area and Severity Index
Time frame: Days 7, 21. 35. 49, 63
Body Surface Area
Time frame: Days 7, 21. 35. 49, 63
Trans-Epidermal Water Loss
Time frame: Days 63
Time to Rescue Medication
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS107E and Hydrocortisone Butyrate 0.1% Cream in people with Atopic Dermatitis, run by DS Biopharma at 1 site in Ireland.
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 7 inclusion and 12 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigator Global Assessment (time frame: 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2019.