Skin Irritation Test of Ten Products

February 16, 2022 updated by: National Taiwan University Hospital
Evaluation of cutaneous tolerance of ten products by primary irritant patch test

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this clinical study was the evaluation of skin irritation potential of ten products after a single application under occlusive patch on human skin.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 to 70 years old, healthy male and female (sex ratio 1:1)
  • No acute or chronic diseases including skin diseases.
  • No current medications.

Exclusion Criteria:

  • Pregnancy or breast feeding.
  • Abnormal blood test result/results (evaluation criteria: WBC, AST, ALT, and Creatinine)
  • Back skin with moles, acne, tattoo, scars, red spots, burns, etc.
  • Current dermatology medication which might affect skin condition evaluation.
  • Current irritated reaction on test site.
  • Participating in other clinical trial(s) within 7 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm
Other: ten products (S01~S10) and two blank (BK1, BK2)
S01 "Functional Peptides Recovering Essence EX" S02 "Advanced Revitalizing Eye Cream" S03 "Advanced Revitalizing Lotion" S04 "NB-1 Anti-Sensitive Repair Activator" S05 "NB-1 Anti-Sensitive Repair Toning Extract" S06 "Ginseng Vitality Serum" S07 "Ginseng Revitalizing Age-defense Essence Cream" S08 "Ginseng Age-defense Eye Cream" S09 "Revital Energy Balance Gel" S10 "Revital Energy Tightening Body Lotion" BK1 "Water" BK2 "Blank" ten products and two blank, 24 hours single application patch test on the back.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/Adverse Event Outcome Measure
Time Frame: Up to 48 hours
Number of participants with Serous and Non-Serous Adverse Event
Up to 48 hours
Total Number of Positive Responses Across All Participants
Time Frame: Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products.
Change from baseline of test products by using ICDRG (International Contact Dermatitis Research Group) grading
Reading results at 30 minutes, 24 hours and 48 hours after the removal of the test products.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: SUNG-JAN LIN, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Anticipated)

April 29, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202107020RSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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