Safety and Efficacy of Facial Cleanser

The Safety and Efficacy of Facial Cleanser Containing Combination of Olive Oil, Virgin Coconut Oil, Butylene Glycol and Hyaluronic Acid on Skin Hydration and Skin Elasticity

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Other: Product X facial cleanser

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Product X facial cleanser; Participants will used Product X facial cleanser twice daily for 5 weeks	Other: Other: Product X facial cleanser; Product X facial cleanser contain olive oil, virgin coconut oil, butylene glycol and hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 20, 2023

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: Cosmetic; Aesthetic
• Other Study ID Numbers: UMRAMREC004-22

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