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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: DS107E
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DS107E and Steroid<br>First 7 days: Steroid taken topically once a day and DS107E taken once a day Next 28 days: DS107E taken topically twice a day | Drug: DS107E<br> <br> * Other names: Mometasone Furoate;|
| Placebo Comparator: Vehicle and Steroid<br>First 7 days: Steroid taken topically once a day and Vehicle taken once a day Next 28 days: Vehicle taken topically twice a day | Drug: Vehicle<br> <br> * Other names: Mometasone Furoate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | Four anatomic sites - head/neck, upper extremities, trunk and lower extremities - are assessed for erythema, induration (papules), excoriation and lichenification as seen on the day of the examination. The severity of each sign is assessed using a 4-point scale | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eczema Area and Severity Index (EASI) | Four anatomic sites - head/neck, upper extremities, trunk and lower extremities - are assessed for erythema, induration (papules), excoriation and lichenification as seen on the day of the examination. The severity of each sign is assessed using a 4-point scale | Days 7, 14, 21 and 35 | 
| Investigator Global Assessment (IGA) | The IGA scale awards a score of 0-4 from clear to severe disease. IGA uses clinical characteristics of erythema, infiltration, population and oozing as scoring guidelines for the overall severity assessment. | Days 7, 14, 21 and 35 | 
| SCORing Atopic Dermatitis | Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) are selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale. | Days 7, 14, 21 and 35 | 
| Target Lesion Score | Moderate to severe target lesions will be graded for erythema, induration, excoriation and lichenification using local SCORAD scales. | Days 7, 14, 21 and 35 | 
| Visual Analogue Scale (VAS) | 11 points scale to assess pruritus | Days 7, 14, 21 and 35 | 
| Skin Tolerability | Skin tolerability will be self-assessed by the subjects using a questionnaire. | Days 7, 14, 21 and 35 | 
| Dermatology Life Quality Index | The DLQI is a simple 10-question validated questionnaire which will be completed at each visit. | Days 7, 14, 21 and 35 | 
| Erythema | Erythema will be assessed with the skin Colorimeter CL 400 | Days 7, 14, 21 and 35 | 
| Transepidermal Water Loss | Measures the effect on skin barrier function. | Days 7, 14, 21 and 35 | 
| Time to Rescue Medication |  | 5 weeks |