Skin Manifestations Clinical Trial
— TDS_TSG_DIOfficial title:
Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging
Verified date | October 2017 |
Source | SRI International |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SRI International | TKL Research, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months | |
Secondary | 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. | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05597254 -
Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation
|
N/A | |
Active, not recruiting |
NCT06140628 -
A 28-day Clinical Study on Facial Skin Rejuvenation
|
N/A | |
Completed |
NCT04154436 -
Effectiveness, Safety, and Cost Efficacy of Water (H2O) as a Substitute for Sodium Bicarbonate (NaHCO3) Plus Solution in Neutralization of Chemical Peeling Using 35% Glycolic Acid Solution
|
N/A | |
Completed |
NCT04449159 -
Efficacy of Vinh Wellness Collagen on Skin Health
|
N/A | |
Enrolling by invitation |
NCT06188338 -
A 56-day Clinical Study on Facial Skin Rejuvenation
|
N/A | |
Completed |
NCT01139047 -
Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
|
Phase 4 | |
Completed |
NCT01139008 -
Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
|
Phase 4 | |
Completed |
NCT05094687 -
Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19).
|
||
Recruiting |
NCT05235997 -
Placebo Controlled Efficacy Evaluation of the Hydrolyzed Collagen Peptide In Adult Females
|
N/A | |
Completed |
NCT01046565 -
Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
|
Phase 1 | |
Completed |
NCT01046396 -
Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
|
Phase 1 | |
Completed |
NCT04701463 -
A Specialized Amino Acid Mixture on Body Composition and Skin State in Overweight and Obese Class I Postmenopausal Women
|
N/A | |
Completed |
NCT02422836 -
Tolerability and Efficacy of Anti-Aging Treatment Regimen in Subjects With Photodamage
|
N/A | |
Completed |
NCT04002856 -
Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck
|
N/A | |
Completed |
NCT03873896 -
The Skin Wrinkle Test: a Simple Clinical Test of Regional Block Success
|
N/A | |
Completed |
NCT03505684 -
Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
|
N/A | |
Active, not recruiting |
NCT06152718 -
New Regenerative Approach for Dermal Renovation (Karisma)
|
||
Recruiting |
NCT04344119 -
Assessment of Chilbains Occuring During Covid-19 Infection
|
||
Recruiting |
NCT06291415 -
The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP)
|
Phase 1 | |
Completed |
NCT05872178 -
Omegia Softgel Clinical Research Program
|
N/A |