A Project to Study Probiotic Beauty Products on Skin Improvement

Chia Nan University of Pharmacy & Science

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

Study Overview

• Status: Completed
• Conditions: Skin Diseases
• Intervention / Treatment: Dietary supplement: TAC/Collagen gel; Dietary supplement: placebo lotion

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 71710
    • Chia Nan University of Pharmacy & Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "A" gel (TAC/Collagen gel); The "A" gel (TAC/Collagen gel) was applied on subjects' right face	Dietary supplement: TAC/Collagen gel; Apply it twice per day for 4 weeks
Placebo Comparator: "B" gel (placebo lotion); the "B" gel (placebo lotion) on their left face	Dietary supplement: placebo lotion; Apply it twice per day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Chia Nan University of Pharmacy ＆ Science
• Collaborators: Glac Biotech Co., Ltd
• Investigators: Principal Investigator: Chia-Hua Liang, PhD, Chia Nan University of Pharmacy ＆ Scienc

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: TSMHIRB-2-R-025-2.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No