NCT05680857

Brief 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. 1.The effect of product on skin hydration of women in Malaysia.
  2. 2.The effect of product on skin elasticity of women in Malaysia.
  3. 3.The effect of product on skin wrinkle of women in Malaysia.
  4. 4.The skin brightening effect of product on Malaysian women.
  5. 5.To observe any adverse effect occurrence with the consumption of the product.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

December 27, 2022

Last Update Submit

November 27, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo group will receive a product in sachet form that doesn't have marine collagen peptide and Coenzyme Q10.

Other: Placebo

Product containing marine collagen peptide and Coenzyme Q10.

EXPERIMENTAL

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.

Interventions

PlaceboOTHER

Product doesn't have active ingredients i.e. marine collagen peptide and Coenzyme Q10.

Placebo
Product containing marine collagen peptide and Coenzyme Q10.OTHER

Product containing marine collagen peptide and Coenzyme Q10.

Product containing marine collagen peptide and Coenzyme Q10.

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Malaysian citizen
  • Women aged 35 - 45 years old
  • Willing to participate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location

MeSH Terms

Interventions

coenzyme Q10

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 11, 2023

Study Start

December 1, 2022

Primary Completion

July 11, 2023

Study Completion

October 30, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)