Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients

Sponsor

DS Biopharma (Industry)

Overall Status

Completed

CT.gov ID

NCT02925793

Collaborator

(none)

327

Enrollment

Locations

Arms

Actual Duration (Months)

109

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this randomized, double blind, placebo controlled, parallel group study is to compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: DS107 Other: Vehicle cream	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

327 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomised, Double-blind, Vehicle-Controlled, Phase IIb Study to Assess the Efficacy and Safety of Topically Applied DS107 Cream to Adults With Mild to Moderate Atopic Dermatitis

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1% DS107 cream Participants in this group will receive 1% DS107 cream twice daily.	Drug: DS107
Experimental: 5% DS107 cream Participants in this group will receive 5% DS107 cream twice daily.	Drug: DS107
Placebo Comparator: Vehicle cream Participants in this group will receive matching placebo cream twice daily.	Other: Vehicle cream

Arm

Intervention/Treatment

Experimental: 1% DS107 cream

Participants in this group will receive 1% DS107 cream twice daily.

Drug: DS107

Experimental: 5% DS107 cream

Participants in this group will receive 5% DS107 cream twice daily.

Drug: DS107

Placebo Comparator: Vehicle cream

Participants in this group will receive matching placebo cream twice daily.

Other: Vehicle cream

Outcome Measures

Primary Outcome Measures

Change from baseline in numerical rating scale (NRS) for pruritus in treated population compared to vehicle population [8 weeks]
Change from baseline in Eczema Area and Severity Index (EASI) in treated population compared to vehicle population [8 weeks]

Secondary Outcome Measures

Change from baseline in NRS for pruritus in treated population compared to vehicle population [10 weeks]
Change from baseline in EASI in treated population compared to vehicle population [10 weeks]
Change from baseline in investigator's global assessment (IGA) score in treated population compared to vehicle population [10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with a clinically confirmed diagnosis of active Atopic Dermatitis according to Hanifin and Rajka criteria
Patients with mild to moderate Atopic Dermatitis at baseline as defined by an IGA score of 3 or 2 at baseline visit
Patients with Atopic Dermatitis covering a minimum 5% of the body surface area at baseline
Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF)

Exclusion Criteria:

Patients with other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the Investigator
Patients who have used systemic treatments (other than biologics) that could affect Atopic Dermatitis less that 4 weeks prior to baseline visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids. Intranasal corticosteroids for stable medical conditions are allowed
Patients who have used any topical medicated treatment for Atopic Dermatitis two weeks prior to the start of treatment/baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, and bleach baths
Patients who use topical products containing urea, ceramides or hyaluronic acid two weeks prior to Day 0
Patients who have a history of hypersensitivity to any substance in DS107 cream or vehicle cream
Patients who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of study results
Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and floride arthritis or any other illness that, in the opinion of the Investigator, is likely to interfere with completion of the study
Patients with chronic infectious diseases (e.g. hepatitis B, hepatitis C, or infection with human immunodeficiency virus)

Contacts and Locations

Locations

	Site	City	State	Country
1	DS Biopharma Site	East Windsor	New Jersey	United States
2	DS Biopharma Site	Markham		Canada
3	DS Biopharma Site	Cape Town		South Africa

Sponsors and Collaborators

DS Biopharma

Investigators

Study Chair: Markus Weissbach, MD, Ph.D, DS Biopharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

DS Biopharma

ClinicalTrials.gov Identifier:

NCT02925793

Other Study ID Numbers:

DS107E-06

First Posted:

Oct 6, 2016

Last Update Posted:

Sep 18, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Dermatitis, Atopic

Dermatitis

Eczema

Study Results

No Results Posted as of Sep 18, 2018