The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

GenMont Biotech Incorporation21 enrolled

Overview

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.

To evaluate the safety and efficacy of hair products containing probiotics

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Skin Problems

Interventions

Test group Probiotic ShampooCOMBINATION_PRODUCT

Probiotic Shampoo

Placebo groupCOMBINATION_PRODUCT

Shampoo base

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Chia Nan University of Pharmacy and Science

Tainan, Taiwan

Outcomes

Primary Outcomes

Skin Microbiota

The changes of scalp microbiota will be evaluated by NGS or qPCR analysis at baseline and different timepoint post-intervention.

Time frame: Baseline, 4 weeks and 8 weeks

Secondary Outcomes

The sebum on scalp

The scalp sebum will be measured by Sebumeter SM815 (C+K, Germany) at baseline and different timepoint post-intervention.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 hour, 24 hours and 48 hour

Repeated application closed patch epicutaneous test under occlusion

Data from ClinicalTrials.gov

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