Skin Irritation Test of Ten Products

NCT ID: NCT05245383

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-17

Study Completion Date

2022-06-30

Brief Summary

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Evaluation of cutaneous tolerance of ten products by primary irritant patch test

Detailed Description

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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.

Conditions

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Dermatitic Reaction of Face

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type OTHER

ten products (S01~S10) and two blank (BK1, BK2)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SUNG-JAN LIN

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Sung-Jan Lin

Role: CONTACT

02 - 23123456 ext. 62141

Po-Hua Chen

Role: CONTACT

02 - 23123456 ext. 62141

Facility Contacts

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SUNG-JAN LIN

Role: primary

+8862-23123456 ext. 62141

PO-HUA CHEN

Role: backup

+886-2-23123456 ext. 62141

References

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Horita K, Tanoue C, Yasoshima M, Ohtani T, Matsunaga K. Study of the usefulness of patch testing and use test to predict the safety of commercial topical drugs. J Dermatol. 2014 Jun;41(6):505-13. doi: 10.1111/1346-8138.12505.

Reference Type BACKGROUND
PMID: 24909212 (View on PubMed)

Fullerton A, Benfeldt E, Petersen JR, Jensen SB, Serup J. The calcipotriol dose-irritation relationship: 48 hour occlusive testing in healthy volunteers using Finn Chambers. Br J Dermatol. 1998 Feb;138(2):259-65. doi: 10.1046/j.1365-2133.1998.02071.x.

Reference Type BACKGROUND
PMID: 9602871 (View on PubMed)

Other Identifiers

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202107020RSD

Identifier Type: -

Identifier Source: org_study_id

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