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CompletedNCT03676036Updated Sep 18, 2018

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

A Phase 2 interventional study of DS107E and Vehicle in Atopic Dermatitis, sponsored by DS Biopharma. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by DS Biopharma · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jun 2015, registered Jan 2018).
Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 42 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

DS Biopharma is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    DS107E and Steroid

    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

  • Placebo comparator
    Vehicle and Steroid

    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

  • DrugDS107E

    Also known as: Mometasone Furoate

  • DrugVehicle

    Also known as: Mometasone Furoate

06

What researchers measure

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

    Time frame: 5 weeks

Secondary 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

    Time frame: Days 7, 14, 21 and 35

  2. 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.

    Time frame: Days 7, 14, 21 and 35

  3. 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.

    Time frame: Days 7, 14, 21 and 35

  4. Target Lesion Score

    Moderate to severe target lesions will be graded for erythema, induration, excoriation and lichenification using local SCORAD scales.

    Time frame: Days 7, 14, 21 and 35

  5. Visual Analogue Scale (VAS)

    11 points scale to assess pruritus

    Time frame: Days 7, 14, 21 and 35

  6. Skin Tolerability

    Skin tolerability will be self-assessed by the subjects using a questionnaire.

    Time frame: Days 7, 14, 21 and 35

  7. Dermatology Life Quality Index

    The DLQI is a simple 10-question validated questionnaire which will be completed at each visit.

    Time frame: Days 7, 14, 21 and 35

  8. Erythema

    Erythema will be assessed with the skin Colorimeter CL 400

    Time frame: Days 7, 14, 21 and 35

  9. Transepidermal Water Loss

    Measures the effect on skin barrier function.

    Time frame: Days 7, 14, 21 and 35

  10. Time to Rescue Medication

    Time frame: 5 weeks

07

Study locations

1 site
  • DS Biopharma Investigational Site
    Lubeck, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03676036
Lead sponsor
DS Biopharma
Responsible party
Sponsor
First posted
Sep 18, 2018
Start date
Jun 2015
Primary completion
Mar 2018
Completion
Jul 2018
Last update
Sep 18, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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