Efficacy Testing of Melon Oil Olive Pressed Candy Products

To assess melon and oil olive pressed candy on skin condition improvement

Study Overview

• Status: Completed
• Conditions: Skin Condition
• Intervention / Treatment: Dietary supplement: Placebo candy; Dietary supplement: melon and oil olive pressed candy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan City, Taiwan
    • Chia Nan University of Pharmacy ＆ Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults aged above 18 years old
• ITA° value 20°-41°

Exclusion Criteria:

• Involuntary subjects.
• Subjects who have a history of skin diseases such as psoriasis, eczema, atopic dermatitis, severe acne; or suffer from other chronic systemic disease.
• Those with known cosmetic, drug or food allergies.
• Female who is pregnant or nursing or planning to become pregnant during the course of the study.
• Subjects who have taken oral or topical corticosteroids and other anti-inflammatory drugs in the past 1 month.
• Use of any products or drugs that affect skin color such as fruit acid, salicylic acid (such as Hydroquinone preparations) in the past 2 months.
• In the past 3 months, the test site has used retinoic acid preparations or undergone chemical peeling, laser, pulse light and other medical aesthetic therapists
• Subjects who can not avoid long-term sun exposure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo candy	Dietary supplement: Placebo candy; consume 2 tablets per day
Experimental: melon and oil olive pressed candy	Dietary supplement: melon and oil olive pressed candy; consume 2 tablets per day; Other Names: Melon, oil olive and pomegranate blend pressed candy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of skin wrinkles	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units	Change from Baseline skin wrinkles at 12 weeks
The change of skin texture	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units	Change from Baseline skin texture at 12 weeks
The change of skin melanin index	Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units	Change from Baseline skin melanin index at 12 weeks
The change of skin erythema index	Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units	Change from Baseline skin erythema index at 12 weeks
The change of skin L* value	Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units	Change from Baseline L* value at 12 weeks
The change of skin b* value	Chroma Meter MM500 was utilized to measure skin b* value. Units: arbitrary units	Change from Baseline b* value at 12 weeks
The change of skin ITA° value	Chroma Meter MM500 was utilized to measure skin ITA° value. Units: arbitrary units	Change from Baseline ITA° value at 12 weeks
The change of skin spots	VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units	Change from Baseline skin spots at 12 weeks
The change of skin UV spots	VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units	Change from Baseline skin UV spots at 12 weeks
The change of skin brown spots	VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units	Change from Baseline skin brown spots at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of TEAC of blood	Venous blood was sampled to measure TEAC	Change from Baseline TEAC at 12 weeks
The change of SOD of blood	Venous blood was sampled to measure SOD	Change from Baseline SOD at 12 weeks
The change of GSH-Px of blood	Venous blood was sampled to measure GSH-Px	Change from Baseline GSH-Px at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of self-assessment skin and hair condition	A self-assessment questionnaire was collected to evaluate skin and hair condition	Change from Baseline skin and hair condition at 12 weeks

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Chia-Hua Liang, Prof., Chia Nan University of Pharmacy ＆ Science

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 23-049-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No