NCT05691413

Brief Summary

This study is conducted to evaluate the safety and effectiveness of facial cleanser X containing combination of olive oil, virgin coconut oil, butylene glycol and hyaluronic acid on skin hydration and skin elasticity. The study duration is 5 weeks and the skin assessment will be carried out at baseline, week 3 and week 5.The main questions this study aims to answer are:

  1. 1.The effect of product on skin hydration.
  2. 2.The effect of product on skin elasticity.
  3. 3.To observe any adverse effect occurrence with the usage of the product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

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
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

January 10, 2023

Last Update Submit

November 27, 2023

Conditions

Healthy

Keywords

AestheticCosmetic

Outcome Measures

Primary Outcomes (3)

  • Change in skin hydration from baseline and at week 3 and 5 after using facial cleanser X

    Skin hydration will be assessed using JANUS III skin analyzer

    Baseline, week 3 and week 5

  • Change in skin elasticity from baseline and at week 3 and 5 after using facial cleanser X

    Skin elasticity will be assessed using JANUS III skin analyzer

    Baseline, week 3 and week 5

  • Adverse effect after using facial cleanser X

    Based on adverse effect occurrence on participants that occur during study period (5 weeks)

    Week 5

Study Arms (1)

Product X facial cleanser

EXPERIMENTAL

Participants will used Product X facial cleanser twice daily for 5 weeks

Other: Other: Product X facial cleanser

Interventions

Other: Product X facial cleanserOTHER

Product X facial cleanser contain olive oil, virgin coconut oil, butylene glycol and hyaluronic acid

Product X facial cleanser

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Malaysia citizen
  • Male and female (age 35-55 years old)

You may not qualify if:

  • Participants who have acne which require medical treatment.
  • Participants taking isotretinoin
  • Participants who had undergo any cosmetic procedures such as laser \& light treatment, botulinum toxin A injections and chemical peeling for the past 3 months
  • Participants who are immunocompromised
  • Participants with history of facial surgery

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 20, 2023

Study Start

December 1, 2022

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)