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| Name | Class |
|---|---|
| Chia Nan University of Pharmacy and Science | OTHER |
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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.
To evaluate the safety and efficacy of hair products containing probiotics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test group Probiotic Shampoo | Combination Product | Probiotic Shampoo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The sebum on scalp | The scalp sebum will be measured by Sebumeter SM815 (C+K, Germany) at baseline and different timepoint post-intervention. | Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks |
| The scalp flakes (dandruff) |
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Inclusion Criteria:
- Healthy volunteers between the ages of 20-70.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ching-Gong Lin, PhD | Chia Nan University of Pharmacy ＆ Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chia Nan University of Pharmacy and Science | Tainan | 71710 | Taiwan |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Placebo group | Combination Product | Shampoo base |
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The scalp flakes will be evaluated by D-SQAME ® DANDRUFF TESTER at baseline and different timepoint post-intervention.
| 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. | 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. | 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. | 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. | Day 1, 2, 3, 4 and 5 |
| D008722 | Methods |