Human Repeated Insult Patch Test[HRIPT] of Blackmores Natural Vitamin E Cream product

Phase 1

Completed

• Conditions: Healthy volunteers age between 20-60 years old; Human Repeated Insult Patch Test

• Registration Number: TCTR20220214004
• Lead Sponsor: Blackmore Limited

Brief Summary

All of the test products (Natural Vitamin E Cream Lanolin, Natural Vitamin E Cream Firm & Smooth Skin, Natural Vitamin E Cream PABA Free and Natural Vitamin E Cream Skin Barrier were not irritants or sensitizers (No reaction was observed at any time)

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-06-14
• Study Start: 2022-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

1. Male and female age between 20-60 years, in general good health based on study screener [no physical required]
2. Individuals who have normal to sensitive skin classified by self-perceived using a Participant screening form and Sensitive Questionaire
3. Individuals who have normal any skin type or ethnicity, provided their degree o skin pigmentation does not significantly interfere with evaluations. Skin type I to IV according to Fitzpatrick scale is preferred
4. Individuals who are free from any dermatological disordor such as wound, psoriasis, rosacca, atopic dermatitis including a know history of allergies

Exclusion Criteria

1. Woman who are pregnant, nursing or planning on becomimg pregnant during the course of the study
2. Individuals with any visible dermatological condition [e.g. psoriasis] the could interfere with evaluations
3. Individuals with abnormal skin pigmentation at the test sites that could interfere with subsequent evaluations of dermal responsiveness or individuals who have skin type of V or VI based on Fitzpatrick scale
4.Individuals who take medications that could interfere with the test results, including any regimen of steroidal/non-steroidal anti-inflammatory drugs or antihistamines
5. Individuals who are allergic to cosmetics or personal care products
6. Individuals who are currently under treatment for asthma or diabetes
7. Individuals who currently enroll in clinical study or participation in a patch test study within 14 days prior to the start of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitization and irritation reaction skin test area 6 weeks Digital photograph, Visual assesment

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A