The Efficacy of Topical Serum X for Skin Brightening

• Sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05693948
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

This study is conducted to evaluate the effectiveness of topical serum X containing arbutin and glutathione for skin brightening. The study duration is 12 weeks and the skin assessment will be carried out at baseline, week 4, 8 and week 12.The main questions this study aims to answer are:

1. The skin brightening effect of the product on facial skin.

2. To observe any adverse effect occurrence with the usage of the product.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Other: Serum X	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Efficacy of Topical Serum X Containing Arbutin and Glutathione for Skin Brightening
• Actual Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Serum X Participants will used serum X twice daily for 12 weeks	Other: Other: Serum X; Serum X contain arbutin and glutathione

Outcome Measures

Primary Outcome Measures

1. Changes in skin tone from baseline and at week 4, week 8, and week 12 after usage of serum X. [Baseline and at week 4, week 8, and week 12]

   Skin tone will be assessed using JANUS III skin analyzer

2. Adverse effect after using serum X [Week 12]

   Based on adverse effect occurrence on participants that occur during study period (12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Malaysia citizen

• Male and female (age 18-30 years old)

Exclusion Criteria:

• Participant with severe acne skin condition

• Participant who is taking isotretinoin, immunocompromised patients and received laser and light treatment within the last three months

• Participant who undergo whitening or cosmetic treatments such as botox and dermal fillers within the previous six month

• Participant with a history of facial surgery such as facelift or nose reshaping

• Participant with history of allergies to any ingredient in the study product

• Participant who is pregnant or plan to get pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre	Petaling Jaya	Selangor	Malaysia	47810

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
• ClinicalTrials.gov Identifier: NCT05693948
• Other Study ID Numbers: UMRAMREC001-22
• First Posted: Jan 23, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre: Aesthetic; Cosmetic

Study Results

No Results Posted as of Jan 26, 2023