NCT05657379

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day 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

1.1 years

First QC Date

December 7, 2022

Last Update Submit

November 27, 2023

Conditions

Healthy

Keywords

Middle-aged women, moisturizer

Outcome Measures

Primary Outcomes (4)

  • Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X

    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

    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

    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

    Based on adverse effect occurrence on participants that occur during study period (8 weeks)

    Week 8

Study Arms (1)

Product X moisturizer

EXPERIMENTAL

Participants will used Product X moisturizer twice daily for 8 weeks

Other: Other: Product X moisturizer

Interventions

Other: Product X moisturizerOTHER

Product X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water

Product X moisturizer

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

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

December 7, 2022

First Posted

December 20, 2022

Study Start

August 15, 2022

Primary Completion

September 30, 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)