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

NCT03676036 | Completed Phase 2

• 1 other identifier: DS107E-04
• Study Type: interventional
• Target: 42
• 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 28 days DS107E or vehicle will be topically administered twice a day. This study will enrol approximately 40 adult patients.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Eczema Area and Severity Index (EASI)

  Days 7, 14, 21 and 35

• Investigator Global Assessment (IGA)

  Days 7, 14, 21 and 35

• SCORing Atopic Dermatitis

  Days 7, 14, 21 and 35

• Target Lesion Score

  Days 7, 14, 21 and 35

• Visual Analogue Scale (VAS)

  Days 7, 14, 21 and 35

Study Arms (2)

DS107E and Steroid

EXPERIMENTAL

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

Vehicle and Steroid

PLACEBO COMPARATOR

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

Interventions

DS107E DRUG

Also known as: Mometasone Furoate

DS107E and Steroid

Vehicle DRUG

Also known as: Mometasone Furoate

Vehicle and Steroid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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).

Sponsors & Collaborators

• DS Biopharma: lead

Study Sites (1)

DS Biopharma Investigational Site

Lübeck, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Mometasone Furoate

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: September 18, 2018
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

DE (1)