Skin Problems
Conditions
Keywords
Hair health, Scalp health, Probiotics, Scalp microbiota
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.
Detailed description
To evaluate the safety and efficacy of hair products containing probiotics
Interventions
COMBINATION_PRODUCTTest group Probiotic Shampoo
Probiotic Shampoo
COMBINATION_PRODUCTPlacebo group
Shampoo base
Sponsors
Chia Nan University of Pharmacy and Science
GenMont Biotech Incorporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Microbiota | 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
| Measure | Time frame | Description |
|---|---|---|
| The scalp flakes (dandruff) | 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. |
| The hair density (hairs/scalp area) | 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. |
| The sebum on scalp | 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. |
| Single application closed patch epicutaneous test under occlusion | 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. |
| Repeated application closed patch epicutaneous test under occlusion | 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. |
| Adverse Event | Baseline and 28 weeks | Any adverse event, such as erythema,rash, itching and so on will be recorded during the intervention. |
Countries
Taiwan
Outcome results
None listed