The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

Phase 2

Completed

• Conditions: Skin Problems
• Interventions: Combination Product: Placebo group; Combination Product: Test group Probiotic Shampoo

• Registration Number: NCT04566549
• Lead Sponsor: GenMont Biotech Incorporation

Brief Summary

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

To evaluate the safety and efficacy of hair products containing probiotics

Study Timeline

• Study Start: 2020-07-06
• Status Verified: 2020-09
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-28
• Primary Completion: 2020-12-06
• Study Completion: 2021-02-06
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo group	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.
Test group	Test group Probiotic Shampoo	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The scalp flakes (dandruff)	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks	The scalp flakes will be evaluated by D-SQAME ® DANDRUFF TESTER at baseline and different timepoint post-intervention.
The sebum on scalp	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks	The scalp sebum will be measured by Sebumeter SM815 (C+K, Germany) at baseline and different timepoint post-intervention.
Adverse Event	Baseline and 28 weeks	Any adverse event, such as erythema,rash, itching and so on will be recorded during the intervention.
The hair density (hairs/scalp area)	Baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks	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.
Single application closed patch epicutaneous test under occlusion	1 hour, 24 hours and 48 hour	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.
Repeated application closed patch epicutaneous test under occlusion	Day 1, 2, 3, 4 and 5	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.

Trial Locations

Locations (1)

Chia Nan University of Pharmacy and Science; 🇨🇳 Tainan, Taiwan