The Safety and Efficacy Evaluation of Hair Products Containing Probiotics

NCT04566549 | Completed Phase 2

• 1 other identifier: TSMH IRB 20-040-A
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Problems

Keywords

Hair health; Scalp health; Probiotics; Scalp microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The sebum on scalp

  Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks

• The scalp flakes (dandruff)

  Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks

• The hair density (hairs/scalp area)

  Baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks

• Adverse Event

  Baseline and 28 weeks

• Single application closed patch epicutaneous test under occlusion

  1 hour, 24 hours and 48 hour

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Test group

ACTIVE COMPARATOR

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

Interventions

Test group Probiotic Shampoo COMBINATION_PRODUCT

Probiotic Shampoo

Also known as: Probiotic Group

Test group

Placebo group COMBINATION_PRODUCT

Shampoo base

Also known as: Control Group

Placebo group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy volunteers between the ages of 20-70.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GenMont Biotech Incorporation: lead
• Chia Nan University of Pharmacy and Science: collaborator

Study Sites (1)

Chia Nan University of Pharmacy and Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ching-Gong Lin, PhD

  Chia Nan University of Pharmacy ＆ Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 28, 2020
• Study Start: July 6, 2020
• Primary Completion: December 6, 2020
• Study Completion: February 6, 2021
• Last Updated: August 18, 2021

Record last verified: 2020-09

Locations

TW (1)