Efficacy and Steroid Sparing Potential Study of DGLA Cream in Early Childhood Patients With Moderate to Severe Atopic Dermatitis

NCT ID: NCT03676933

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-04-25

Brief 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.

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DS107E and Steroid

First 7 days: Steroid taken topically once a day and DS107E taken once a day Next 56 days: DS107E taken topically twice a day

Group Type: EXPERIMENTAL

DS107E

Intervention Type: DRUG

Hydrocortisone Butyrate 0.1% Cream

Intervention Type: DRUG

Steroid taken topically once a day

Vehicle and Steroid

First 7 days: Steroid taken topically once a day and DS107E taken once a day Next 56 days: DS107E taken topically twice a day

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Hydrocortisone Butyrate 0.1% Cream

Intervention Type: DRUG

Steroid taken topically once a day

Interventions

DS107E

Intervention Type: DRUG

Vehicle

Intervention Type: DRUG

Hydrocortisone Butyrate 0.1% Cream

Steroid taken topically once a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female and male infants aged 3-12 months.

2. Diagnosis of atopic dermatitis according to the Hanifin and Rajka Criteria.

3. Patients with moderate to severe atopic dermatitis (IGA ≥3)

4. Patients with atopic dermatitis covering a minimum of 10% of the body surface area at baseline.

5. Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.

6. 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.

7. Patients who have completed the tolerability patch test without any adverse effects after 72 hours.

Exclusion Criteria

1. 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.

2. Clinically significant impairment of renal or hepatic function.

3. Clinically significant immunodeficiency.

4. Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).

5. Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).

6. 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%).

7. 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.

8. Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline), or 5 half-lives (whichever is longer).

9. 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.

10. 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.

11. Use of topical products containing ceramides 2 weeks prior to Day 0.

12. Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DS Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DS Biopharma Investigational Site

Dublin, , Ireland

Countries

Ireland

Other Identifiers

DS107E-05

Identifier Type: -

Identifier Source: org_study_id