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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Vehicle; Drug: DS107E; Drug: Hydrocortisone Butyrate 0.1% Cream

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • DS Biopharma Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: DS107E; Drug: Hydrocortisone Butyrate 0.1% Cream; Steroid taken topically once a day
PLACEBO_COMPARATOR: 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	Drug: Vehicle; Drug: Hydrocortisone Butyrate 0.1% Cream; Steroid taken topically once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment		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.	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment		Days 7, 21. 35. 49, 63
Eczema Area and Severity Index	Proportion of patients achieving a reduction in EASI score	Days 7, 21. 35. 49, 63
Body Surface Area		Days 7, 21. 35. 49, 63
Trans-Epidermal Water Loss		Days 63
Time to Rescue Medication		9 weeks

Collaborators and Investigators

• Sponsor: DS Biopharma

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 25, 2016

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Inflammatory Agents; Dermatologic Agents; Hydrocortisone; Hydrocortisone-17-butyrate
• Other Study ID Numbers: DS107E-05