The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

NCT ID: NCT04566549

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-06

Study Completion Date

2021-02-06

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

Conditions

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Skin Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type COMBINATION_PRODUCT

Shampoo base

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).

Group Type ACTIVE_COMPARATOR

Test group Probiotic Shampoo

Intervention Type COMBINATION_PRODUCT

Probiotic Shampoo

Interventions

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Test group Probiotic Shampoo

Probiotic Shampoo

Intervention Type COMBINATION_PRODUCT

Placebo group

Shampoo base

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Probiotic Group Control Group

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chia Nan University of Pharmacy and Science

OTHER

Sponsor Role collaborator

GenMont Biotech Incorporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ching-Gong Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Chia Nan University of Pharmacy & Science

Locations

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Chia Nan University of Pharmacy and Science

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TSMH IRB 20-040-A

Identifier Type: -

Identifier Source: org_study_id

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