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

NCT02787356 | Withdrawn DMC

• 1 other identifier: RFA-FD-16-010-SRI-TKL-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Skin Manifestations

Keywords

Skin Diseases, Erythema

Outcome Measures

Primary Outcomes (1)

• Assessing Accuracy of Berger & Bowman Dermal Response Scores Predicted from Images of Skin

  The accuracy of the image analysis system will be assessed on a test set of skin images by analyzing the results of an 8x8 confusion matrix, where the ground truth labels are the scores on the 8-point Berger \& Bowman Dermal Response Scale assigned by trained observers, and the classification results are the predicted Berger \& Bowman Dermal Response scores from the image analysis system. Accuracy is defined as the number of predicted scores within 1 grade of the ground truth scores, divided by the total number of samples in the test set.

  3 months

Secondary Outcomes (1)

• Assessing Non-Inferiority of Generic Lidocaine 5% TDS from Images of Skin

  3 months

Study Arms (2)

TDS Lidocaine 5%; generic

EXPERIMENTAL

TDS Lidocaine 5%; generic with trained skin graders and images of skin

Drug: TDS Lidocaine 5%; generic

TDS Lidocaine 5%; RLD

EXPERIMENTAL

TDS Lidocaine 5%; RLD with trained skin graders and images of skin

Drug: TDS Lidocaine 5%; RLD

Interventions

TDS Lidocaine 5%; generic DRUG

TDS Lidocaine 5%; generic

TDS Lidocaine 5%; generic

TDS Lidocaine 5%; RLD DRUG

TDS Lidocaine 5%; RLD

TDS Lidocaine 5%; RLD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females, age \[18-65 years old or 18 years or older\]
• Signed informed consent
• Good general health

You may not qualify if:

• 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.

Sponsors & Collaborators

• SRI International: lead
• TKL Research, Inc.: collaborator

Related Links

• Use of Imaging and Digital Image Analysis Software/s to Evaluate Transdermal Irritation and Non - inferiority of Generic Transdermal Products (U01)

MeSH Terms

Conditions

Skin Manifestations; Skin Diseases; Erythema

Interventions

Drugs, Generic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Jonathan Dosik, MD

  TKL Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: October 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share