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.

NCT07154004 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-04

No results posted yet for this study

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.

Conditions

  • No Protrusion
  • No Open Wound
  • No Severe Allergic Reaction
  • No Scar
  • No Tattoo
  • No Significant Skin Defect

Interventions

OTHER

Test Serum 897222 210

Repeated application

OTHER

Test Serum 897222 212

Repeated application

OTHER

Test Serum 897250 39

Repeated application

OTHER

Test Serum 897250 102D

Repeated application

OTHER

Test Serum 774569 67

Repeated application

Sponsors & Collaborators

  • BEIJING YUANBEN INFORMATION CONSULTING CO., LTD

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-21
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154004 on ClinicalTrials.gov