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



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:December 2016
End Date:July 2018

Use our guide to learn which trials are right for you!

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

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.


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)
We found this trial at
2
sites
East Windsor, New Jersey
?
mi
from
East Windsor, NJ
Click here to add this to my saved trials
?
mi
from
Markham,
Click here to add this to my saved trials