8-Week Atopic Dermatitis (AD) Treatment Study



Status:Completed
Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - 65
Updated:9/8/2018
Start Date:November 27, 2017
End Date:August 18, 2018

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This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream
treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).

This will be a 9-week, randomized, double blind, parallel comparison study consisting of a
1-week washout phase followed by an 8-week treatment phase. This study will be executed by
one clinical research company utilizing two test sites and up to 62 subjects with moderate or
severe atopic dermatitis, ages 12-65, will be enrolled. Subjects that are enrolled will be
placed on one of three products (e.g. Sponsor's Experimental Cream Treatment, a basic
moisturizer, or a positive control - Desonide) and will be required to use the assigned
product twice a day for the duration of the 8-week treatment phase.

Inclusion Criteria:

- Is a generally healthy, male or female, 12-65 years old, inclusive;

- Diagnosis of moderate or greater Atopic Dermatitis as determined by SCORAD (SCORAD
>=25);

- Is able to read and understand instructions in English.

Exclusion Criteria:

- Is currently participating or has participated in another interventional clinical
study in the past 2 weeks;

- Currently or has been diagnosed or treated for cancer in the past 5 years;

- Requires any topical or systemic medications that could affect the course of their
atopic dermatitis during the study period (except inhaled steroids and/or stable
antihistamines for asthma or allergies);

- Has used systemic treatments that could affect AD within 30 days or 5 half- lives.
(i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea),
azathioprine and oral/injectable corticosteroids);

- Has a known hypersensitivity to any corticosteroid creams;

- Has been diagnosed with any allergies to Oat or derivatives;

- Has any active infections or has used antibiotics in the past 7 days;

- Has any physical attributes or skin conditions that might interfere with the clear
visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos,
extensive scarring, excessive hair growth or acne);

- Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS,
lupus rheumatoid arthritis) which could place the subject at risk or interfere with
the accuracy of the study results;

- Has used any immunosuppressant drugs or immunotherapy within the past 30days or 5
half-lives;

- Is an employee of the sponsor company or clinical testing site;

- Is diabetic;

- Presents with the presence of an active or chronic allergic reaction as evidenced by
an irregular white cell count determined by eosinophils > 0.3 X 109/L at Screening
Visit;

- Is planning a trip to a sunny climate, to use tanning booths or use other UV sources
throughout the course of this study;

- Has a history of hypersensitivity to any substance in investigational preparation or
to Desonide;

- Has any clinically significant 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 the study results;

- Is dependent on oral medication for any skin disease/condition or could not, in the
opinion of the Investigator tolerate the restriction of discontinuing the medicine as
required in this study;

- Is currently pregnant or lactating or planning to become pregnant in the next 6
months;

- Has other skin conditions that might interfere with AD diagnosis and/or evaluation
(i.e. psoriasis current active viral, bacterial and fungal skin infections) as
assessed by the Investigator;

- Any other condition or factor the Investigator or their duly assigned representative
believes may affect the ability of the subject to complete the study or the
interpretation
We found this trial at
2
sites
Raleigh, North Carolina 27612
Principal Investigator: Adnan Nasir, MD, Ph.D,
Phone: 919-781-2514
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Raleigh, NC
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6035 Shallowford Road
Chattanooga, Tennessee 37421
Principal Investigator: Richard A Krause, MD
Phone: 423-698-4584
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Chattanooga, TN
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