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OpenTrials
Completed

NCT Number: NCT05657379

Effect of Moisturizer on Malaysian Women Facial Skin

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.

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Key information

Conditions

Healthy

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Petaling Jaya, Selangor, 47810, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Other: Product X moisturizer

Other

Product X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. Adverse effect after using Product X

    Time frame: Week 8

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

Sponsors and collaborators

Lead sponsor

USMARI Research & Innovation Centre

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2022
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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