A Project to Study Probiotic Beauty Products on Skin Improvement
Primary Purpose
Skin Diseases
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TAC/Collagen gel
placebo lotion
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers aged above 20 years old
Exclusion Criteria:
- Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
- Female who is pregnant or nursing or planning to become pregnant during the course of the study.
- Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
- Involuntary subject
- People who is taking chronic disease medication
Sites / Locations
- Chia Nan University of Pharmacy & Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
"A" gel (TAC/Collagen gel)
"B" gel (placebo lotion)
Arm Description
The "A" gel (TAC/Collagen gel) was applied on subjects' right face
the "B" gel (placebo lotion) on their left face
Outcomes
Primary Outcome Measures
Effects of the TAC/Collagen Gel on Human Skin Hydration
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Effects of the TAC/Collagen Gel on Human Skin Sebum
Callegari 1930 was utilized to measure skin inflammation. Units: arbitrary units.
Effects of the TAC/Collagen gel on Human Skin Inflammation
Chroma Meter MM-500 was utilized to measure skin inflammation. Units: arbitrary units.
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05276661
First Posted
March 3, 2022
Last Updated
March 3, 2022
Sponsor
Chia Nan University of Pharmacy & Science
Collaborators
Glac Biotech Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05276661
Brief Title
A Project to Study Probiotic Beauty Products on Skin Improvement
Official Title
Chia Nan University of Pharmacy & Science
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Nan University of Pharmacy & Science
Collaborators
Glac Biotech Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"A" gel (TAC/Collagen gel)
Arm Type
Experimental
Arm Description
The "A" gel (TAC/Collagen gel) was applied on subjects' right face
Arm Title
"B" gel (placebo lotion)
Arm Type
Placebo Comparator
Arm Description
the "B" gel (placebo lotion) on their left face
Intervention Type
Dietary Supplement
Intervention Name(s)
TAC/Collagen gel
Intervention Description
Apply it twice per day for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo lotion
Intervention Description
Apply it twice per day for 4 weeks
Primary Outcome Measure Information:
Title
Effects of the TAC/Collagen Gel on Human Skin Hydration
Description
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Time Frame
Subjects will be tested in the 4th week
Title
Effects of the TAC/Collagen Gel on Human Skin Sebum
Description
Callegari 1930 was utilized to measure skin inflammation. Units: arbitrary units.
Time Frame
Subjects will be tested in the 4th week
Title
Effects of the TAC/Collagen gel on Human Skin Inflammation
Description
Chroma Meter MM-500 was utilized to measure skin inflammation. Units: arbitrary units.
Time Frame
Subjects will be tested in the 4th week
Title
Effect of TAC/Collagen Gel on Human Acne Healing and Porphyrins Numbers
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
Title
Effects of the TAC/Collagen Gel on Human Skin Brown Spot Numbers
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers aged above 20 years old
Exclusion Criteria:
Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
Female who is pregnant or nursing or planning to become pregnant during the course of the study.
Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
Involuntary subject
People who is taking chronic disease medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang, PhD
Organizational Affiliation
Chia Nan University of Pharmacy & Scienc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia Nan University of Pharmacy & Science
City
Tainan
ZIP/Postal Code
71710
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Project to Study Probiotic Beauty Products on Skin Improvement
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