THE SAFETY AND EFFICACY OF HYDROLYZED COLLAGEN TONIC DRINK ON SKIN WRINKLE, ELASTICITY, HYDRATION, AND OVERALL SKIN CONDITION IN HEALTHY THAI WOME

Phase 1

Recruiting

• Conditions: healthy female volunteers with mild to advance skin aging scores; Skin Aging

• Registration Number: TCTR20190103002
• Lead Sponsor: Chulabhorn International College of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Study Completion: 2019-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

1) Female subjects aged 40 - 60 yrs.
2) Glogau classification of facial aging type I - III
3) Fitzpatrick classification of skin type I - V
4) In general, good health and mental condition
5) Being able to read and write in Thai Language
6) Voluntarily to comply with study rules and able to visit the clinic as schedule
7) Personal informed consents to participate in the study

Exclusion Criteria

1) Acute skin diseases (e.g. atopic eczema, atopic dermatitis, psoriasis) on the test sites, or other dermatological disorders (scars, sunburn, moles)
2) Food allergies against ingredients of the test products, gastrointestinal diseases or indigestion
3) Systemic medication with anti-inflammatory agents or antibiotics and/or antihistamines within 4 weeks prior to the start
4) On oral contraceptive
5) Pregnancy or breastfeeding
6) Subjects with a significant past medical history which in the opinion of the investigator would compromise the safety of the subjects
7) Subjects with immunological disorders or systemic illness, severe disorders within 6 months prior to the start, e.g. cancer, acute cardiac and circulatory disorders, severe diabetes, or severe skin-related pathologies (i.e., skin cancer, psoriasis, eczema, melisma)
8) BMI ˃23
9) Alcohol and drug abuse
10) Participation in other studies on cosmetic products in the test areas within 2 weeks prior to the start or during the study, participation in a study with a pharmaceutical preparation within 4 weeks prior to the start
11) Exposure to intensive sunlight or artificial UV (solarium) light on the test sites within 1 week prior to the start or during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical assessments of skin ageing and eye wrinkling size day 1, day 30, day 60, day 90 Assessed by three dermatologists with Glogau Classification of Photoaging,Biophysical measurement of left / right lateral eyes canthus day 1, day 30, day 60, day 90 Visio scan® VC 98 USB and Antera3D®

Secondary Outcome Measures

Name	Time	Method
Skin Elasticity at left/right upper cheek day 1, day 30, day 60, day 90 Cutometer® dual mpa 580 ,TEWL measurement day 1, day 30, day 60, day 90 Tewameter® TM210,Dermal fluid level of procollagen type 1, elastin, fibrillin and biglycan day 1, day 30, day 60, day 90 ELISA test,Skin Moisture, Elasticity, Clarity, Wrinkle, Rejuvenation and Overall skin condition day 1, day 30, day 60, day 90 Self-Assessment score,Frequency of GI effects, skin effects, other allergenic reactions and Product palatability day 1, day 30, day 60, day 90 Self-Assessment score,Biochemical parameter day 1, day 30, day 60, day 90 Blood laboratory test