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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02787356
Recruitment Status : Withdrawn (Project was not funded by FDA)
First Posted : June 1, 2016
Last Update Posted : October 9, 2017
TKL Research, Inc.
Information provided by (Responsible Party):
SRI International

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

Condition or disease Intervention/treatment Phase
Skin Manifestations Drug: TDS Lidocaine 5%; generic Drug: TDS Lidocaine 5%; RLD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02787356

Sponsors and Collaborators
SRI International
TKL Research, Inc.
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Principal Investigator: Jonathan Dosik, MD TKL Research, Inc.
Additional Information:
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Responsible Party: SRI International Identifier: NCT02787356    
Other Study ID Numbers: RFA-FD-16-010-SRI-TKL-002
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SRI International:
Skin Diseases, Erythema
Additional relevant MeSH terms:
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Skin Manifestations
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action