Sensitive skin clinical study of cosmetic products (PSF, PSDO, PSCN, CME) : HRIPT

Not Applicable

Completed

• Conditions: Healthy female who have self- perceived sensitive skin (classified using Sensitive skin questionnaire for human repeated insult patch test); human repeated insult patch test; Home use test; sensitive skin; safety test

• Registration Number: TCTR20181119004
• Lead Sponsor: nilever thai services co. ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-02-23
• Study Start: 2018-11-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

-Female aged between 20-60 years, in general good health based on a study screener (no physical examination required)
- Individuals who have sensitive skin classified by self-self perceived using a Sensitive Skin Questionnaire
- Female volunteer of any skin type or ethnicity, provide their degree of skin pigmentation does not significantly interfere with evaluations
- Individual free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which could interfere with the conduct of the study, interpretation of results or increase risk of adverse reactions
- Individuals who agree to refrain from swimming, using hot tubs/saunas and any type of tanning
- Individuals who are able to read, understand and provide written informed consent
- Individuals who agree to complete the course of the study and to comply with instructions

Exclusion Criteria

- Women who are pregnant, nursing or planning on becoming pregnant during the course of the study
- Individuals with any visible dermatological condition (e.g. psoriasis) that could interfere with evaluations
- Individuals with abnormal skin pigmentation at the test sites that could interfere with subsequent evaluations of dermal responsiveness
- Individuals who take medications that could interfere with the test results, includind regimen of steroidal/ non- steroidal anti-inflammatory drugs or antihistamines
- Individuals who are allergic to cosmetics or personal care products
- Individuals who are currently under treatment for asthma or diabetes
- Individuals who are currently enroll in clinical study or participation in a patch test study with in 14 days prior to the start of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin irritation (skin response scoring) Induction phase: 3 times/week (for 3 weeks) / Resting phase: 2 weeks /Challenge phase 1 times Patch test (Human Repeated Insult Patch Test: HRIPT),Skin irritation and safety of cosmetic products after 2 weeks usage Home Use Test (HUT): Questionnaire

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A