MedPath

Efficacy Determination of Skin Lightening Body Lotions SWBL4 and FBL65

Not Applicable
Completed
Conditions
Healthy Thai female subjects aged between 25&#45
60 years
Registration Number
TCTR20190617001
Lead Sponsor
nilever thai services co. ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
33
Inclusion Criteria

1. Healthy volunteers with an age in a range of 25-60 year old
2. Having dark skin and one homogenous 3x3 cm area on each lateral forearm for product use, clinical and instrumental evaluation
3. Having little or no hair on the lateral forearm
4. Having experience using counter brand
5.No history of allergies against any components of trial products or lightening cosmetics
6. Be able to use only provided products and no other similar products during the test period
7. No functional supplements with improving skin condition or no treatment prior to the clinical test for 1 month
8. Agree to refrain from using any cream, lotions, moisturizers, sunscreens, bath addictive or any other skin products on the forearm for the during of washout phase and study period
9. Agree to refrain from using depilatory cream or shaving thr forearm during the course of study
10. Agreement on refraining from swimming, tanning and sunbathing during the cause of the study
11. Be able to read, write and communicate well in Thai
12. Be able to follow the study protocol
13. Understanding and willing to give consent of the volunteer

Exclusion Criteria

1. Regular use of the cream, lotions, moisturizers, sunscreens, bath additives or any other skin products on the forearms
2. Having big skin color difference between two forearms
3. Having history of any type of cancer in the last five years
4. Having other erythema, sunburn, cuts and/or abrasions on the forearms
5. Taking medication which the investigator believes may influence the interpretation of the data, such as photosensitizing drugs or chronic users of corticiosteriods or non-steroidial anti-inflammatoies (Ibruprofen or aspirins)
6. Having extreamly dry skin
7. Participating in any other study concurrently
8. Participated in the study in which the lateral forearms were used as a test site within 3 months prior to the start of this study
9. Current use of having a skin lightening or alpha hydroxyl acid product on the forearm within the last 6 months
10. Current use or having usr the hormonal contractive method, e.g pill, injection, implant, with the last 6 months
11. Having any of the following conditions or factor that investigator belives may effect the response of the skin or the interpretation of the test results, including, but not limited to, diabets, pregnancy, lactation, vascular disease, hepatitis, eczema, psoriasis and acne
12. History of major operation within 1 year
13. Working as a fieldworker or salesperson

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quantification of the lightening effect week 0, 1, 2, 4 Chromameter,Erythema Value ane melanin index week 0, 1, 2, 4 Mexameter,Visual evaluation the product effect week 0, 1, 2, 4 photography,Consumer eslf-assessment week 1, 2, 4 Questionnaire form
Secondary Outcome Measures
NameTimeMethod
/A N/A N/A
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