Skin ManifestationsTDS_TSG_DINCT02787356
Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging
A study testing TDS Lidocaine 5%; generic and TDS Lidocaine 5%; RLD in people with Skin Manifestations, run by SRI International.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Manifestations
- What is being tested?
- TDS Lidocaine 5%; generic and TDS Lidocaine 5%; RLD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and Females, age [18-65 years old or 18 years or older]
- Signed informed consent
- Good general health
Who cannot join
- 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,
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- 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.
About this study
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
Read the 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.
- Conditions
- Skin Manifestations
- Being tested
- TDS Lidocaine 5%; generic, TDS Lidocaine 5%; RLD
- Keywords
- Skin Diseases, Erythema
- Medical subject headings
- Skin Manifestations, Skin Diseases, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDS Lidocaine 5%; genericDrug
TDS Lidocaine 5%; generic
TDS Lidocaine 5%; RLDDrug
TDS Lidocaine 5%; RLD
| Study group | Role | What they receive |
|---|---|---|
| TDS Lidocaine 5%; generic | Experimental | TDS Lidocaine 5%; generic with trained skin graders and images of skin Receives: Drug: TDS Lidocaine 5%; generic |
| TDS Lidocaine 5%; RLD | Experimental | TDS Lidocaine 5%; RLD with trained skin graders and images of skin Receives: Drug: TDS Lidocaine 5%; RLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start1 Oct 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Project was not funded by FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SRI International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Jonathan Dosik, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787356
- Sponsor's protocol ID
- RFA-FD-16-010-SRI-TKL-002
- Acronym
- TDS_TSG_DI
- Status last verified
- Oct 2017
- First submitted
- 23 May 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging
- ClinicalTrials.gov ID
- NCT02787356
- Acronym / sponsor ID
- TDS_TSG_DI / RFA-FD-16-010-SRI-TKL-002
- Conditions
- Skin Manifestations
- Keywords
- Skin Diseases, Erythema
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project was not funded by FDA
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SRI InternationalIndustry (pharma, biotech, devices)
- Collaborators
- TKL Research, Inc.
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDS Lidocaine 5%; generic | Experimental | Drug: TDS Lidocaine 5%; genericTDS Lidocaine 5%; generic with trained skin graders and images of skin |
| TDS Lidocaine 5%; RLD | Experimental | Drug: TDS Lidocaine 5%; RLDTDS Lidocaine 5%; RLD with trained skin graders and images of skin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females, age [18-65 years old or 18 years or older]
- Signed informed consent
- Good general health
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDS Lidocaine 5%; genericTDS Lidocaine 5%; generic | Drug | TDS Lidocaine 5%; generic |
| TDS Lidocaine 5%; RLDTDS Lidocaine 5%; RLD | Drug | TDS Lidocaine 5%; RLD |
Primary outcome
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.
1 secondary outcome
Assessing Non-Inferiority of Generic Lidocaine 5% TDS from Images of Skin
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Use of Imaging and Digital Image Analysis Software/s to Evaluate Transdermal Irritation and Non - inferiority of Generic Transdermal Products (U01)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Dosik, MD principal investigator
TKL Research, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing TDS Lidocaine 5%; generic and TDS Lidocaine 5%; RLD in people with Skin Manifestations, run by SRI International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Accuracy of Berger & Bowman Dermal Response Scores Predicted from Images of Skin (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.