Canine Atopic Dermatitis Study

Clinical Trial Link   ATOPY TRIAL

Background: In previous double blind, placebo controlled studies, the T-Cell Receptor Immune Modulating Peptides (TCR Peptides) have shown highly significant improvements in dogs with atopic dermatitis as measured by the Canine Atopic Dermatitis Extent and Severity Index [1].  The following study is designed to satisfy regulatory approval for dogs with atopic dermatitis.  More about the TCR Peptides (click here):

The following generally describes the atopic dermatitis study.

Investigator Eligibility: Qualified veterinarians and dermatologists able to enroll between 18 – 36 dogs over 4 months.
Conditions: Good Clinical Practices, United States Department of Agriculture – CVB regulated
Product: T-cell Receptor Peptide (injectable; SQ)
Design: 6-week double blind placebo controlled in up to 36 dogs per clinic
Treatment Schedule: TCR peptide or placebo on Days 1 and 14, administered SQ
Data Capture: 3 veterinary exams, 2 Chem +CBC, 2 frozen serum for later analysis by Sponsor for cytokines and biomarkers

Inclusion criteria

• Dogs with a history of non-seasonal chronic atopic dermatitis for at least 1 year
• Diagnosis of atopic dermatitis based on standard criteria
• If on desensitization therapy, must have been on the same therapy for at least 9 months
• Systemic administration of corticosteroids must have been discontinued for at least 4 weeks
• Cyclosporine or tacrolimus therapy must have been discontinued for at least 4 weeks

Exclusion criteria – Dogs with/that

• Concurrent uncontrolled food allergies or flea dermatitis
• Are likely to require systemic corticosteroids to remain acceptably non-pruritic
• Have been started on desensitization therapy within the last 9 months  Dogs with known medical conditions that could interfere with evaluation of treatment outcome
• Uncontrolled bacterial or fungal infection of any organ
• Have received any stem cell / bone marrow transplant or related procedure within 9 months
• Pregnant or lactating dogs

Reimbursement: Reimbursement is available for all cases, contact Dr. Craig Woods at k9docwoods@gmail.com if interested in receiving more information.
Additional Support:  The Sponsor intends on supporting investigating clinics by making veterinarians and owners aware of the study via faxes, regional advertising, internet advertising, and website referrals.

Interested Veterinary Dermatologists may contact Dr. Craig Woods at k9docwoods@gmail.com to learn more.
[1] Data presented at the American Association of Veterinary Pharmacology and Therapeutics Conference (2011).