Clinical trial NCT05276661: A Project to Study Probiotic Beauty Products on Skin Improvement
Official title: Chia Nan University of Pharmacy & Science
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases
Lead sponsor: Chia Nan University of Pharmacy ＆ Science
Sponsor class: OTHER
Collaborators: name: Glac Biotech Co., Ltd
First posted: 2022-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of the TAC/Collagen Gel on Human Skin Hydration
timeFrame: Subjects will be tested in the 4th week
measure: Effects of the TAC/Collagen Gel on Human Skin Sebum
timeFrame: Subjects will be tested in the 4th week
measure: Effects of the TAC/Collagen gel on Human Skin Inflammation
timeFrame: Subjects will be tested in the 4th week
measure: Effect of TAC/Collagen Gel on Human Acne Healing and Porphyrins Numbers
timeFrame: Subjects will be tested in the 4th week
measure: Effects of the TAC/Collagen Gel on Human Skin Brown Spot Numbers
timeFrame: Subjects will be tested in the 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Scienc
name: Chia-Hua Liang, PhD
role: PRINCIPAL_INVESTIGATOR
References: