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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Other: Product containing marine collagen peptide and Coenzyme Q10.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Petaling Jaya, Selangor, Malaysia, 47810
      • Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The placebo group will receive a product in sachet form that doesn't have marine collagen peptide and Coenzyme Q10.	Other: Placebo; Product doesn't have active ingredients i.e. marine collagen peptide and Coenzyme Q10.
Experimental: Product containing marine collagen peptide and Coenzyme Q10.; This group will receive the product containing marine collagen peptide from the fish origin and Coenzyme Q10 in sachet form.	Other: Product containing marine collagen peptide and Coenzyme Q10.; Product containing marine collagen peptide and Coenzyme Q10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: December 27, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: UMRAMREC005-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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