Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation

Healthy Clinical Trial

Official title:

The Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation in Malaysian Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680857
• Other study ID #: UMRAMREC005-22
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a placebo-controlled study conducted to investigates the safety and efficacy of products containing marine collagen peptide and CoQ10 in enhancing skin rejuvenation of Malaysian women. The study duration is 28 days and the skin assessment will be carried out at baseline, Day 14 and Day 28.The main questions it aims to answer are:

1. The effect of product on skin hydration of women in Malaysia.

2. The effect of product on skin elasticity of women in Malaysia.

3. The effect of product on skin wrinkle of women in Malaysia.

4. The skin brightening effect of product on Malaysian women.

5. To observe any adverse effect occurrence with the consumption of the product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 30, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• Malaysian citizen

• Women aged 35 - 45 years old

• Willing to participate

Exclusion Criteria:

• Women with skin diseases or any underlying diseases.

• Pregnant, breastfeeding women or planned pregnancy during the study period

• Allergy to collagen or other ingredients that may be found in the product.

• Women who had any cosmetic procedures such as botox, laser and light treatment, facial surgery, and any procedures that may improve skin hydration, elasticity, wrinkles, and brightening of skin four weeks before the study.

• Women who took any dietary supplements, functional foods, or medicines that could have the same or similar effects as the product evaluated in this study in the past three months.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Placebo
Product doesn't have active ingredients i.e. marine collagen peptide and Coenzyme Q10.
• Product containing marine collagen peptide and Coenzyme Q10.
Product containing marine collagen peptide and Coenzyme Q10.

Locations

Country	Name	City	State
Malaysia	Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre	Petaling Jaya	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in skin hydration from baseline and at Day 14 and Day 28 after consumption of a product.	Skin hydration will be assessed using JANUS III skin analyzer and comparison will be made with placebo group.	Baseline, Day 14 and Day 28
Primary	Changes in skin elasticity from baseline and at Day 14 and Day 28 after consumption of a product.	Skin elasticity will be assessed using JANUS III skin analyzer comparison will be made with placebo group.	Baseline, Day 14 and Day 28
Primary	Changes in skin wrinkles from baseline and at Day 14 and Day 28 after consumption of a product.	Skin wrinkles will be assessed using JANUS III skin analyzer comparison will be made with placebo group.	Baseline, Day 14 and Day 28
Primary	Changes in skin tone from baseline and at Day 14 and Day 28 after consumption of a product.	Skin hydration will be assessed using JANUS III skin analyzer comparison will be made with placebo group.	Baseline, Day 14 and Day 28
Primary	Adverse effect after consumption of product containing marine collagen peptide and coenzyme Q10.	Based on adverse effect occurrence on participants that occur during study period (28 days)	28 Days