Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-09 @ 2:25 PM
Study NCT ID:
NCT03676933
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2018-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Steroid Sparing Potential Study of DGLA Cream in Early Childhood Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
DS Biopharma
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: