The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

Testing of Hair Products Containing Probiotics

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.

Study Overview

• Status: Completed
• Conditions: Skin Problems
• Intervention / Treatment: Combination product: Placebo group; Combination product: Test group Probiotic Shampoo

Detailed Description

To evaluate the safety and efficacy of hair products containing probiotics

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 71710
    • Chia Nan University of Pharmacy and Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Combination product: Placebo group; Shampoo base; Other Names: Control Group
Active Comparator: Test group; 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; Probiotic Shampoo; Other Names: Probiotic Group

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GenMont Biotech Incorporation
• Collaborators: Chia Nan University of Pharmacy and Science
• Investigators: Principal Investigator: Ching-Gong Lin, PhD, Chia Nan University of Pharmacy & Science

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): December 6, 2020
• Study Completion (Actual): February 6, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Probiotics; Hair health; Scalp health; Scalp microbiota
• Other Study ID Numbers: TSMH IRB 20-040-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No