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

Primary Purpose

Skin Manifestations

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

TDS Lidocaine 5%; generic

TDS Lidocaine 5%; RLD

About this trial

This is an interventional other trial for Skin Manifestations focused on measuring Skin Diseases, Erythema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TDS Lidocaine 5%; generic

TDS Lidocaine 5%; RLD

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

As a baseline, the non-inferiority of generic vs RLD Lidocaine will first be determined using trained observer scores in the image test set using the method described in "Draft Guidance on Lidocaine" (Rev. Jan 2016), namely that the upper bound of the one-sided 95% confidence interval of the mean test product score minus 1.25 times the mean RLD score must be less than or equal to 0. Then, this same method will be used on the predicted scores in the image test set, and the determination will be compared to the baseline.

Full Information

NCT ID

NCT02787356

First Posted

May 23, 2016

Last Updated

October 6, 2017

Sponsor

SRI International

Collaborators

TKL Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02787356

Brief Title

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

Acronym

TDS_TSG_DI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Project was not funded by FDA

Study Start Date

October 1, 2017 (Anticipated)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SRI International

Collaborators

TKL Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

Subjects will be screened prior to dosing to ensure subjects meet all inclusion exclusion criteria. The test materials will be tested simultaneously. Skin sites on the paraspinal region will be utilized for application. The test sites will be randomized among the individual subjects according to their assigned identification number. All patches will be applied and removed by the laboratory staff. Due to safety concerns, it is not recommended to simultaneously apply two whole, active, Lidocaine Patch 5% patches on the same subject during the 21-day period. The optimum design of this study will depend on the design of the test product patch. Since the RLD has a matrix design that can be safely cut, one-fourth of the patch can be used for these studies. If the test product patch also has a design that can be cut to a smaller size, it should also be cut in one-fourth and one-fourth of the test product patch applied simultaneously with one-fourth of a RLD patch (to separate skin sites). Each test article will be applied to sites on the skin for a contact period of approximately 24 hours (+/-1 hr.), with the exception of the weekend (72 hours, +/- 1 hr.). There will be no visits during the weekend. Evaluations will be made after removal of every patch by a single trained grader along with a single digital imaging instrument. Re-applications will be made to the same test sites unless reactions become so strong (combination of a number and letter grade of 3) as to make this unadvisable, at which point patch application will be discontinued for that test article.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Manifestations

Keywords

Skin Diseases, Erythema

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TDS Lidocaine 5%; generic

Arm Type

Experimental

Arm Description

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

Arm Title

TDS Lidocaine 5%; RLD

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TDS Lidocaine 5%; generic

Intervention Description

TDS Lidocaine 5%; generic

Intervention Type

Drug

Intervention Name(s)

TDS Lidocaine 5%; RLD

Intervention Description

TDS Lidocaine 5%; RLD

Primary Outcome Measure Information:

Title

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

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Dosik, MD

Organizational Affiliation

TKL Research, Inc.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-010.html

Description

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

Learn more about this trial

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

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