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

September 17, 2018 updated by: DS Biopharma

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Lubeck, Germany
        • DS Biopharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other Names:
  • Mometasone Furoate
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
Other Names:
  • Mometasone Furoate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eczema Area and Severity Index (EASI)
Time Frame: 5 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eczema Area and Severity Index (EASI)
Time Frame: Days 7, 14, 21 and 35
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)
Time Frame: Days 7, 14, 21 and 35
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
Time Frame: Days 7, 14, 21 and 35
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
Time Frame: Days 7, 14, 21 and 35
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)
Time Frame: Days 7, 14, 21 and 35
11 points scale to assess pruritus
Days 7, 14, 21 and 35
Skin Tolerability
Time Frame: Days 7, 14, 21 and 35
Skin tolerability will be self-assessed by the subjects using a questionnaire.
Days 7, 14, 21 and 35
Dermatology Life Quality Index
Time Frame: Days 7, 14, 21 and 35
The DLQI is a simple 10-question validated questionnaire which will be completed at each visit.
Days 7, 14, 21 and 35
Erythema
Time Frame: Days 7, 14, 21 and 35
Erythema will be assessed with the skin Colorimeter CL 400
Days 7, 14, 21 and 35
Transepidermal Water Loss
Time Frame: Days 7, 14, 21 and 35
Measures the effect on skin barrier function.
Days 7, 14, 21 and 35
Time to Rescue Medication
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DS Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS107E-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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