A Project to Study Probiotic Beauty Products on Skin Improvement

Not Applicable

Completed

• Conditions: Skin Diseases
• Interventions: Dietary Supplement: placebo lotion; Dietary Supplement: TAC/Collagen gel

• Registration Number: NCT05276661
• Lead Sponsor: Chia Nan University of Pharmacy ＆ Science

Brief Summary

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

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 Timeline

• Study Start: 2020-05-18
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-15
• Status Verified: 2022-03
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"B" gel (placebo lotion)	placebo lotion	the "B" gel (placebo lotion) on their left face
"A" gel (TAC/Collagen gel)	TAC/Collagen gel	The "A" gel (TAC/Collagen gel) was applied on subjects' right face

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chia Nan University of Pharmacy ＆ Science; 🇨🇳 Tainan, Taiwan