Back to resultsEfficacy Testing of Melon Oil Olive Pressed Candy Products
Primary Purpose
Skin Condition
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo candy
melon and oil olive pressed candy
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 25-55 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
Sites / Locations
- Chia Nan University of Pharmacy & Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo candy
melon and oil olive pressed candy
Arm Description
Outcomes
Primary Outcome Measures
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin melanin index
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
The change of skin erythema index
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units
The change of skin L* value
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units
The change of skin b* value
Chroma Meter MM500 was utilized to measure skin b* value. Units: arbitrary units
The change of skin ITA° value
Chroma Meter MM500 was utilized to measure skin ITA° value. Units: arbitrary units
The change of skin spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
The change of skin UV spots
VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
The change of skin brown spots
VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
Secondary Outcome Measures
The change of TEAC of blood
Venous blood was sampled to measure TEAC
The change of SOD of blood
Venous blood was sampled to measure SOD
The change of GSH-Px of blood
Venous blood was sampled to measure GSH-Px
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05988567
Brief Title
Efficacy Testing of Melon Oil Olive Pressed Candy Products
Official Title
Efficacy Testing of Melon Oil Olive Pressed Candy Products
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess melon and oil olive pressed candy on skin condition improvement
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo candy
Arm Type
Placebo Comparator
Arm Title
melon and oil olive pressed candy
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo candy
Intervention Description
consume 2 tablets per day
Intervention Type
Dietary Supplement
Intervention Name(s)
melon and oil olive pressed candy
Other Intervention Name(s)
Melon, oil olive and pomegranate blend pressed candy
Intervention Description
consume 2 tablets per day
Primary Outcome Measure Information:
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Time Frame
Change from Baseline skin wrinkles at 12 weeks
Title
The change of skin texture
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Change from Baseline skin texture at 12 weeks
Title
The change of skin melanin index
Description
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
Time Frame
Change from Baseline skin melanin index at 12 weeks
Title
The change of skin erythema index
Description
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units
Time Frame
Change from Baseline skin erythema index at 12 weeks
Title
The change of skin L* value
Description
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units
Time Frame
Change from Baseline L* value at 12 weeks
Title
The change of skin b* value
Description
Chroma Meter MM500 was utilized to measure skin b* value. Units: arbitrary units
Time Frame
Change from Baseline b* value at 12 weeks
Title
The change of skin ITA° value
Description
Chroma Meter MM500 was utilized to measure skin ITA° value. Units: arbitrary units
Time Frame
Change from Baseline ITA° value at 12 weeks
Title
The change of skin spots
Description
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
Time Frame
Change from Baseline skin spots at 12 weeks
Title
The change of skin UV spots
Description
VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
Time Frame
Change from Baseline skin UV spots at 12 weeks
Title
The change of skin brown spots
Description
VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
Time Frame
Change from Baseline skin brown spots at 12 weeks
Secondary Outcome Measure Information:
Title
The change of TEAC of blood
Description
Venous blood was sampled to measure TEAC
Time Frame
Change from Baseline TEAC at 12 weeks
Title
The change of SOD of blood
Description
Venous blood was sampled to measure SOD
Time Frame
Change from Baseline SOD at 12 weeks
Title
The change of GSH-Px of blood
Description
Venous blood was sampled to measure GSH-Px
Time Frame
Change from Baseline GSH-Px at 12 weeks
Other Pre-specified Outcome Measures:
Title
The change of self-assessment skin and hair condition
Description
A self-assessment questionnaire was collected to evaluate skin and hair condition
Time Frame
Change from Baseline skin and hair condition at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults aged 25-55 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang, Prof.
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia Nan University of Pharmacy & Science
City
Tainan City
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Efficacy Testing of Melon Oil Olive Pressed Candy Products
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