- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05693948
The Efficacy of Topical Serum X for Skin Brightening
November 27, 2023 updated by: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
The Efficacy of Topical Serum X Containing Arbutin and Glutathione for Skin Brightening
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:
- The skin brightening effect of the product on facial skin.
- To observe any adverse effect occurrence with the usage of the product.
Study Overview
Study Type
Interventional
Enrollment (Actual)
34
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
-
-
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
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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
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: Serum X
Participants will used serum X twice daily for 12 weeks
|
Serum X contain arbutin and glutathione
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in skin tone from baseline and at week 4, week 8, and week 12 after usage of serum X.
Time Frame: Baseline and at week 4, week 8, and week 12
|
Skin tone will be assessed using JANUS III skin analyzer
|
Baseline and at week 4, week 8, and week 12
|
|
Adverse effect after using serum X
Time Frame: Week 12
|
Based on adverse effect occurrence on participants that occur during study period (12 weeks
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
September 1, 2022
Primary Completion (Actual)
May 31, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
January 11, 2023
First Posted (Actual)
January 23, 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
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.