Clinical trial NCT03676036: Efficacy and Steroid Sparing Potential Study of DGLA Cream in Patients With Moderate to Severe Atopic Dermatitis
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 Patients With Moderate To Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: DS Biopharma
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 28 days DS107E or vehicle will be topically administered twice a day.

This study will enrol approximately 40 adult patients.

Detailed description: Subjects will come to the clinic on 7 occasions: Screening, Baseline, Day 7, Day 14, Day 21, Day 35 (End of Treatment) and Day 42 (Follow-up). The primary efficacy variable will be EASI (Eczema Area and Severity Index). The secondary efficacy variables will be EASI, IGA (Investigators Global Assessment), SCORAD (SCORing Atopic Dermatitis), Target Lesion Score, VAS (Visual Analogue Scale), Skin Tolerability, DLQI (Dermatology Life Quality Index), Erythema, TEWL (Transepidermal Water Loss) and Time to Rescue Medication.

Eligibility criteria: Inclusion Criteria:

* Female and male volunteers aged 18-65 who are willing to give written informed consent.
* Diagnosis of atopic dermatitis (\> 6 months) according to the Hanifin and Raika Criteria;
* Presence of at least 2 moderate to severe (target lesion score\</=8) inflammatory lesions of comparable severity, erythema \>/= 2
* Patients with moderate to severe atopic dermatitis (IGA=3-4)
* A body surface area score of less than 20%

Exclusion Criteria:

* Clinically significant impairment of renal or hepatic function.
* 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 or intolerance to any ingredient in Ecural®(Mometasone furoate 0.1%). Of note, any intolerance to PHB ester (benzoate, parabens) or soy or it's cross-allergen peanut, as these are ingredients of DS107E.
* Use of biologics 3 months prior to start of treatment/ Day 0 visit (baseline), or 5 half-lives (whichever is longer).
* Use of systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable 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, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to Day 0 visit (baseline) and/or is planning a trip to sunny climate or to use tanning booths 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. Topical products that do not contain ceramides are allowed.
* Use of anti-histamines for atopic dermatitis within 2 weeks of baseline.
* Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).
* History of clinically significant drug or alcohol abuse in the last year prior to Day 0 (baseline).

Primary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: 5 weeks
Secondary outcomes:
measure: Eczema Area and Severity Index (EASI)
timeFrame: Days 7, 14, 21 and 35
measure: Investigator Global Assessment (IGA)
timeFrame: Days 7, 14, 21 and 35
measure: SCORing Atopic Dermatitis
timeFrame: Days 7, 14, 21 and 35
measure: Target Lesion Score
timeFrame: Days 7, 14, 21 and 35
measure: Visual Analogue Scale (VAS)
timeFrame: Days 7, 14, 21 and 35
measure: Skin Tolerability
timeFrame: Days 7, 14, 21 and 35
measure: Dermatology Life Quality Index
timeFrame: Days 7, 14, 21 and 35
measure: Erythema
timeFrame: Days 7, 14, 21 and 35
measure: Transepidermal Water Loss
timeFrame: Days 7, 14, 21 and 35
measure: Time to Rescue Medication
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Lubeck
country: Germany
facility: DS Biopharma Investigational Site
Study officials:
References: