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Withdrawn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
Sponsored by
About this trial
This is an interventional other trial for Skin Manifestations focused on measuring Skin Diseases, Erythema
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Assessing Non-Inferiority of Generic Lidocaine 5% TDS from Images of Skin
Description
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.
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
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
No
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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