Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging (TDS_TSG_DI)
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|ClinicalTrials.gov Identifier: NCT02787356|
Recruitment Status : Withdrawn (Project was not funded by FDA)
First Posted : June 1, 2016
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Skin Manifestations||Drug: TDS Lidocaine 5%; generic Drug: TDS Lidocaine 5%; RLD||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging|
|Estimated Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: TDS Lidocaine 5%; generic
TDS Lidocaine 5%; generic with trained skin graders and images of skin
Drug: TDS Lidocaine 5%; generic
TDS Lidocaine 5%; generic
Experimental: TDS Lidocaine 5%; RLD
TDS Lidocaine 5%; RLD with trained skin graders and images of skin
Drug: TDS Lidocaine 5%; RLD
TDS Lidocaine 5%; RLD
- Assessing Accuracy of Berger & Bowman Dermal Response Scores Predicted from Images of Skin [ Time Frame: 3 months ]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.
- Assessing Non-Inferiority of Generic Lidocaine 5% TDS from Images of Skin [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787356
|Principal Investigator:||Jonathan Dosik, MD||TKL Research, Inc.|