Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to (1) collect trained observer scores and digital images of skin irritated by generic and RLD Lidocaine 5% delivered via TDS, and (2) assess performance of an automated system for predicting scores directly from the digital images

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SRI International
• Collaborator: TKL Research, Inc.
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Males and Females, age [18-65 years old or 18 years or older]

• Signed informed consent

• Good general health

Exclusion Criteria:

• Subject is pregnant or lactating.

• Medical history of condition that would significantly influence the immune response (e.g., primary or acquired immunodeficiencies, such as HIV positive or AIDS, allergic diseases, such as anaphylaxis, asthma or generalized drug reaction, neoplasms, such as lymphoma or leukemia, rheumatoid arthritis, or systemic lupus erythematosus).

• Medical history of significant dermatologic diseases or conditions, such as atopy, psoriasis, vitiligo or conditions known to alter skin appearance or physiologic response (e.g. diabetes, porphyria).

• History of significant dermatologic cancers (e.g. melanoma, squamous cell carcinoma), except basal cell carcinomas that were superficial and did not involve the investigative site.

• Medical history of hepatic disease

• Within three weeks prior to dosing, use of medications or treatments that would significantly influence or exaggerate responses to the test product or that would alter inflammatory or immune response to the product (e.g. cyclosporine, tacrolimus, systemic or topical corticosteroids, cytotoxic drugs, immune globulin,

• Bacillus Calmette-Guerin, monoclonal antibodies, radiation therapy).

• Within 72 hours prior to dosing, use of antihistamines or use of topical drugs at patch site.

• Subject has an obvious difference in skin color between arms or the presence of a skin condition, excessive hair at the application sites, scar tissue, tattoo, or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug.

• Presence of open sores at the application site.