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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Withdrawn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
Sponsored by
SRI International
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    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

    First Posted
    May 23, 2016
    Last Updated
    October 6, 2017
    Sponsor
    SRI International
    Collaborators
    TKL Research, Inc.
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    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)

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

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