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

NCT03676933 | Completed Phase 2

• 1 other identifier: DS107E-05
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Investigator Global Assessment

  Days 7, 21. 35. 49, 63

• Eczema Area and Severity Index

  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

Study Arms (2)

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

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

Drug: Vehicle; Drug: Hydrocortisone Butyrate 0.1% Cream

Interventions

DS107E DRUG

DS107E and Steroid

Vehicle DRUG

Vehicle and Steroid

Hydrocortisone Butyrate 0.1% Cream DRUG

Steroid taken topically once a day

DS107E and Steroid; Vehicle and Steroid

Eligibility Criteria

• Age: 3 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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%).
• 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).

Sponsors & Collaborators

• DS Biopharma: lead

Study Sites (1)

DS Biopharma Investigational Site

Dublin, Ireland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

hydrocortisone-17-butyrate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: September 19, 2018
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 25, 2016
• Last Updated: February 8, 2019

Record last verified: 2019-01

Locations

IE (1)