A Project to Study Probiotic Beauty Products on Skin Improvement

Skin Diseases Clinical Trial

Official title:

Chia Nan University of Pharmacy & Science

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276661
• Other study ID #: TSMHIRB-2-R-025-2.1
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: March 2022
• Source: Chia Nan University of Pharmacy & Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study was to use probiotic beauty products for 4 weeks and evaluate the impact of products on healthy skin.

Description:

Twenty subjects were recruited and informed to apply the lotion gel twice per day (3~5 mg/cm2 once) for 4 weeks. Two kinds of facial lotiongels, "A" gel and "B" gel, were provided to every subject. The "A" gel (TAC/Collagen lotiongel) was applied on subjects' right face and the "B" gel (placebo lotion) on their left face (formula showed as Table S2). Ordinary cosmetics usage was permitted but any change of usage was not allowed during the intervention. Outdoor activities (sun exposure) and the usage of sunscreen lotion were not limited in this study. Every subject was required to inspect his/her skin condition on week 0 and 4. Before inspection, the face was washed with water and waited for 30 min in an air-conditioned room (25°C, humility 55 ± 5%). Among these 20 subjects, eight of them had severe acne with at least two acne lesions on each side of face when participating this trial. They were instructed for more visits to evaluate the symptom of acne on week 1 and 2.

Skin hydration (Corneometer CM825, Courage + Khazaka Electroni, Germany), sebum (Callegari 1930, Italy), and inflammation detection (Chroma Meter MM-500, Minolta, Japan) of upper cheek were measured in every subject. The improvement in inflammation was positively correlated with a decrease of a* value or an increase of L* value. VISIA® Complexion Analysis (VISIA® Complexion Analysis, U.S.A.) was also employed to measure the skin inflammation, porphyrins numbers and brown spot numbers of whole face. The result was presented as the mean value and the relative percentage (%) to the baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 15, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

Healthy volunteers aged above 20 years old

Exclusion Criteria:

1. Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).

2. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.

3. Female who is pregnant or nursing or planning to become pregnant during the course of the study.

4. Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.

5. Involuntary subject

6. People who is taking chronic disease medication

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Dietary Supplement:
• TAC/Collagen gel
Apply it twice per day for 4 weeks
• placebo lotion
Apply it twice per day for 4 weeks

Locations

Country	Name	City	State
Taiwan	Chia Nan University of Pharmacy & Science	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
Chia Nan University of Pharmacy & Science	Glac Biotech Co., Ltd

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of the TAC/Collagen Gel on Human Skin Hydration	Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120	Subjects will be tested in the 4th week
Primary	Effects of the TAC/Collagen Gel on Human Skin Sebum	Callegari 1930 was utilized to measure skin inflammation. Units: arbitrary units.	Subjects will be tested in the 4th week
Primary	Effects of the TAC/Collagen gel on Human Skin Inflammation	Chroma Meter MM-500 was utilized to measure skin inflammation. Units: arbitrary units.	Subjects will be tested in the 4th week
Primary	Effect of TAC/Collagen Gel on Human Acne Healing and Porphyrins Numbers	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Subjects will be tested in the 4th week
Primary	Effects of the TAC/Collagen Gel on Human Skin Brown Spot Numbers	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Subjects will be tested in the 4th week