Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-27 @ 7:08 AM
Study NCT ID:
NCT05642702
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Irritation Patch Test (PIPT) Study Conducted at NovoBliss Research for Shared Panel
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official Title:
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test Under Complete Occlusion or Semi Occlusion or Open Patch on Adult Healthy Human Subjects
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events.
The subject's back between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and edema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.
The subject's back between the scapula and waist will be utilized as application sites. Application sites will be evaluated for scoring the reaction, namely, erythema, dryness, and wrinkles on a 0-4 point scale separately for each parameter and edema on another 0-4 points scale as per the Draize Scale after 30+5 minutes of patch removal, 24±2 hours and 168±2 hours after patch removal.
Detailed Description:
The objective of this study is to evaluate the dermatological safety of the test products by 24 Hours patch test under complete occlusion on healthy adult human subjects and adequate representation of varied skin types (Oily, Dry, Normal, and Combination).
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events. The subject's back i.e. between the scapula and waist will be utilized as application sites.
26 subjects with varied skin types (Oily, Dry, Normal, and Combination, preferably equal ratio) will be enrolled in the study to get 24 completed subjects at the end of study.
The expected total study duration will be approximately 9 days from patch application day.
The duration of this study will be 9 days from enrollment day. There are total of 3 visits in this study and one optional visit.
* Visit 01: Screening, Enrollment, and Patch Application (Day 01)
* Visit 02: Patch Removal after 24 hours of application \& 30 + 5 min Irritation scoring upon patch removal (Day 02)
* Visit 03: 24 (± 2) hours Irritation Scoring (Day 03) after patch removal
* Visit 04: The subject will be contacted telephonically on Day 08 for any signs of irritation at the patch application site. Follow-up visit for reactions if any to confirm recovery (Optional, if deemed necessary) \[Irritation scoring at 168±2 hours post-patch removal (Day 09)\].
Application Sites (Back) will be evaluated for scoring the reaction, namely, erythema, dryness, wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30 + 5 minutes of patch removal (Day 02), 24±2 hours (Day 03) and 168±2 hours (Day 09) after the patch removal.
Scoring data will be updated in tabular format and mean irritation scoring will be obtained from irritation scores and the same will be included in the final Product Summary Report for all test products after completion of the study.
Demographic characteristics and results of the study will be summarized. Any AEs will be summarized with a number and a percentage.
Four parameters namely erythema, dryness, wrinkles and oedema will be scored separately on the irritation scoring sheet. Irritation scoring data will be updated in tabular format. Data of each subject that has completed the initial 03 study visits i.e. Day 01, Day 02, and Day 03 of the study will be considered for Mean Irritation Score Derivation. Mean Irritation Score (MIS) and standard deviation will be calculated using a standard statistical formula for each product. The Product irritancy level will be classified and reported based on the classification of Mean Irritation Score per sec#17.1. Standard deviation will be calculated to provide variability of data.
For calculation of Mean Irritation Score of erythema, dryness and wrinkles the highest score will be taken.
MIS = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each test product / Total no. of Subjects.
This is a single-center, evaluator-blinded study in healthy adult human subjects. Single 24-hour application of sponsor(s) provided test products along with positive and negative controls will be kept in contact with the skin of subjects under occlusion for at least 24 hours (+ 2 hours). The study can be conducted in a single group. Safety will be assessed throughout the study by monitoring adverse events. The subject's back i.e. between the scapula and waist will be utilized as application sites.
26 subjects with varied skin types (Oily, Dry, Normal, and Combination, preferably equal ratio) will be enrolled in the study to get 24 completed subjects at the end of study.
The expected total study duration will be approximately 9 days from patch application day.
The duration of this study will be 9 days from enrollment day. There are total of 3 visits in this study and one optional visit.
* Visit 01: Screening, Enrollment, and Patch Application (Day 01)
* Visit 02: Patch Removal after 24 hours of application \& 30 + 5 min Irritation scoring upon patch removal (Day 02)
* Visit 03: 24 (± 2) hours Irritation Scoring (Day 03) after patch removal
* Visit 04: The subject will be contacted telephonically on Day 08 for any signs of irritation at the patch application site. Follow-up visit for reactions if any to confirm recovery (Optional, if deemed necessary) \[Irritation scoring at 168±2 hours post-patch removal (Day 09)\].
Application Sites (Back) will be evaluated for scoring the reaction, namely, erythema, dryness, wrinkles on a 0-4 point scale separately for each parameter and oedema on another 0-4 points scale as per the Draize Scale after 30 + 5 minutes of patch removal (Day 02), 24±2 hours (Day 03) and 168±2 hours (Day 09) after the patch removal.
Scoring data will be updated in tabular format and mean irritation scoring will be obtained from irritation scores and the same will be included in the final Product Summary Report for all test products after completion of the study.
Demographic characteristics and results of the study will be summarized. Any AEs will be summarized with a number and a percentage.
Four parameters namely erythema, dryness, wrinkles and oedema will be scored separately on the irritation scoring sheet. Irritation scoring data will be updated in tabular format. Data of each subject that has completed the initial 03 study visits i.e. Day 01, Day 02, and Day 03 of the study will be considered for Mean Irritation Score Derivation. Mean Irritation Score (MIS) and standard deviation will be calculated using a standard statistical formula for each product. The Product irritancy level will be classified and reported based on the classification of Mean Irritation Score per sec#17.1. Standard deviation will be calculated to provide variability of data.
For calculation of Mean Irritation Score of erythema, dryness and wrinkles the highest score will be taken.
MIS = Total score (highest score from Erythema, dryness, wrinkles + Oedema) for each test product / Total no. of Subjects.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NBSP22-PIPT-0030-NI | OTHER | NovoBliss Research Private Limited | View |