The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

Study Overview
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Brief Summary
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Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair healthcare.

Detailed Description
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To evaluate the safety and efficacy of hair products containing probiotics

Official Title
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Testing of Hair Products Containing Probiotics

Conditions
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Skin Problems

Intervention / Treatment
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* Combination Product: Test group Probiotic Shampoo
* Combination Product: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy volunteers between the ages of 20-70. Exclusion Criteria: Subjects are undergoing medical therapy for scalp, hair diseases or diabetes mellitus. Subjects with cosmetics allergy. Subjects had accepted the scalp surgery such as Follicular Unit Transpalnt, Follicular Unit Extraction in the past half year. Subjects with pregnancy or breast-feeding.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Shampoo base without probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance. | Combination Product: Placebo group<br>* Shampoo base<br>* Other names: Control Group;|
| Active Comparator: Test group<br>Shampoo base with probiotics inculding Aqua、Sodium Lauryl Ether Sulphate、Cocamidopropyl Betaine、Cocoamide DEA、Sodium、Polyquaternium-10 、Disodium EDTA、Acrylates Copolymer、Citric Acid、Phenoxyethanol、Fragrance、Heat-killed Lactobacillus paracasei powders (5x10^8 cells/ g-shampoo). | Combination Product: Test group Probiotic Shampoo<br>* Probiotic Shampoo<br>* Other names: Probiotic Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Microbiota | The changes of scalp microbiota will be evaluated by NGS or qPCR analysis at baseline and different timepoint post-intervention. | Baseline, 4 weeks and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sebum on scalp | The scalp sebum will be measured by Sebumeter SM815 (C+K, Germany) at baseline and different timepoint post-intervention. | Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks | 
| The scalp flakes (dandruff) | The scalp flakes will be evaluated by D-SQAME ® DANDRUFF TESTER at baseline and different timepoint post-intervention. | Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks | 
| The hair density (hairs/scalp area) | The hair number in a constant scalp area will be measured by Aramo TSII skin/hair diagnosis (Aramhuvis Co., Ltd. Korea) at baseline and different timepoint post-intervention. | Baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks | 
| Adverse Event | Any adverse event, such as erythema,rash, itching and so on will be recorded during the intervention. | Baseline and 28 weeks | 
| Single application closed patch epicutaneous test under occlusion | Probiotics on skin will be evaluated by Human Patch test. The Human Patch test method according to the Guidelines of Human Patch test Standards for Cosmetics, Taiwan Food and Drug Administration, 2019 edition. | 1 hour, 24 hours and 48 hour | 
| Repeated application closed patch epicutaneous test under occlusion | The irritation potential of probiotics on skin will be evaluated by Human Patch test. The Human Patch test method according to the Guidelines of Human Patch test Standards for Cosmetics, Taiwan Food and Drug Administration, 2019 edition. | Day 1, 2, 3, 4 and 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hair health, Scalp health, Probiotics, Scalp microbiota