Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 7:50 AM
Study NCT ID:
NCT07154004
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2025-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sponsor Assigns Test Products to Six Skin Areas According to a Concealed Randomization Schedule; Neither the Evaluating Physicians Nor the Participants Know Which Product is Applied to Which Site, Preventing Bias.
Sponsor:
BEIJING YUANBEN INFORMATION CONSULTING CO., LTD
Organization:
Study Overview
Official Title:
Clinical Study on Epidermal Cell Renewal Efficacy of 5 Products
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
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, double-blind, randomized, and controlled study. The sponsor keeps the allocation of products to the six test sites confidential. Neither the evaluating physicians nor the participants know which product is applied to which site.
The investigator will recruit 33 Chinese female participants and aim to complete the study with at least 30 of them. Each participant will be followed for 23 consecutive days.
* \*\*Day 0\*\*: After signing informed consent and passing screening, a staff member performs a dansyl chloride patch test. The reagent is placed in a Finn chamber, applied to the inner forearm, and sealed with waterproof tape.
* \*\*Day 1 (≥20 h later)\*\*: Participants return to the site. The patches are removed, photographs are taken, and the designated test products are applied to the marked areas.
* \*\*Days 2-21\*\*: Participants visit daily for product application by staff. After each use they report any adverse reactions, specifying symptoms, severity, location, and duration. Starting on Day 1, a dermatologist performs daily clinical scoring and photography of the test areas.
Throughout the study, participants must avoid sunscreen and any other skin-care products on the inner forearms. From Day 0 to Day 1 they may not bathe or wet the forearms; during the remaining application period they may shower but must not rub or scrub the inner forearms, and must still refrain from any other topical products.
The investigator will recruit 33 Chinese female participants and aim to complete the study with at least 30 of them. Each participant will be followed for 23 consecutive days.
* \*\*Day 0\*\*: After signing informed consent and passing screening, a staff member performs a dansyl chloride patch test. The reagent is placed in a Finn chamber, applied to the inner forearm, and sealed with waterproof tape.
* \*\*Day 1 (≥20 h later)\*\*: Participants return to the site. The patches are removed, photographs are taken, and the designated test products are applied to the marked areas.
* \*\*Days 2-21\*\*: Participants visit daily for product application by staff. After each use they report any adverse reactions, specifying symptoms, severity, location, and duration. Starting on Day 1, a dermatologist performs daily clinical scoring and photography of the test areas.
Throughout the study, participants must avoid sunscreen and any other skin-care products on the inner forearms. From Day 0 to Day 1 they may not bathe or wet the forearms; during the remaining application period they may shower but must not rub or scrub the inner forearms, and must still refrain from any other topical products.
Detailed Description:
None
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?: