A Phase 2 interventional study of Test group Probiotic Shampoo and Placebo group in Skin Problems, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by GenMont Biotech Incorporation · Phase 2, Interventional, and Supportive care
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
GenMont Biotech Incorporation is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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- Healthy volunteers between the ages of 20-70.
Exclusion Criteria:
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 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
Also known as: Probiotic Group
Shampoo base
Also known as: Control Group
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
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
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.
Time frame: Day 1, 2, 3, 4 and 5
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
GenMont Biotech Incorporation