Effect of Moisturizer on Malaysian Women Facial Skin

November 27, 2023 updated by: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

The Effect of Product X Moisturizer on Skin Texture of Middle-Aged Women in Malaysia

The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are:

  1. The effect of Product X on skin hydration of middle-aged women in Malaysia.
  2. The effect of Product X on skin elasticity of middle-aged women in Malaysia.
  3. The effect of Product X on skin wrinkle of middle-aged women in Malaysia.
  4. To observe any adverse effect occurrence with the use of Product X.

Participants will used Product X for 8 week and the skin assessment will be carried out at baseline, week 2, 4 and week 8.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Malaysian citizen
  • Middle-aged woman (40-60 years old)

Exclusion Criteria:

  • Participants taking isotretinoin
  • Immunocompromised patients or participants with any skin diseases or diseases that may compromised the participants well-being and study outcome.
  • Participant who undergo any cosmetic procedures such as laser & light treatment for the past three months.
  • Participant with a history of facial surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Product X moisturizer
Participants will used Product X moisturizer twice daily for 8 weeks
Other: Other: Product X moisturizer
Product X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X
Time Frame: Baseline, week 2, 4 and 8
Skin hydration will be assessed using JANUS III skin analyzer
Baseline, week 2, 4 and 8
Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X
Time Frame: Baseline, week 2, 4 and 8
Skin elasticity will be assessed using JANUS III skin analyzer
Baseline, week 2, 4 and 8
Change in skin wrinkles from baseline and at week 2, 4 and 8 after using Product X
Time Frame: Baseline, week 2, 4 and 8
Skin wrinkles will be assessed using JANUS III skin analyzer and Wrinkle Severity Rating Scale (WSRS). For WSRS, dermatologists will evaluate participants' wrinkles based on 5-point photonumeric rating scale that will objectively evaluate the severity of crow's feet at rest (static) and with a smiling expression (dynamic). The scale scores are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.
Baseline, week 2, 4 and 8
Adverse effect after using Product X
Time Frame: Week 8
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2022

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 20, 2022

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

Keywords

Other Study ID Numbers

  • RMC/EC41/2022

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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