Skip to main content
OpenTrials
Completed

NCT Number: NCT04566549

The Safety and Efficacy Evaluation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Problems

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chia Nan University of Pharmacy and Science

Tainan, 71710, Taiwan

About this study

To evaluate the safety and efficacy of hair products containing probiotics

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test group Probiotic Shampoo

Combination Product

Probiotic Shampoo

Other names: Probiotic Group

Placebo group

Combination Product

Shampoo base

Other names: Control Group

Primary outcomes

  1. Skin Microbiota

    Time frame: 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 outcomes

  1. The sebum on scalp

    Time frame: 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.

  2. The scalp flakes (dandruff)

    Time frame: 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.

  3. The hair density (hairs/scalp area)

    Time frame: 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.

  4. Adverse Event

    Time frame: Baseline and 28 weeks

    Any adverse event, such as erythema,rash, itching and so on will be recorded during the intervention.

  5. Single application closed patch epicutaneous test under occlusion

    Time frame: 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.

  6. Repeated application closed patch epicutaneous test under occlusion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GenMont Biotech Incorporation

Industry

Collaborators

  • Chia Nan University of Pharmacy and Science

Registry information

Official study title

Testing of Hair Products Containing Probiotics

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 28, 2020
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.