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Clinical Trials/NCT05276661
NCT05276661CompletedNot Applicable

Chia Nan University of Pharmacy & Science

Chia Nan University of Pharmacy & Science2 sites in 1 country20 target enrollmentStarted: May 18, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Effects of the TAC/Collagen Gel on Human Skin Hydration

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Effects of the TAC/Collagen Gel on Human Skin Hydration

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Subjects will be tested in the 4th week

VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chia Nan University of Pharmacy & Science
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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