The Efficacy of Topical Serum X for Skin Brightening | NCT05693948

Studies
The Efficacy of Topical Serum X for Skin Brightening

NCT05693948

Sponsor

USMARI Research & Innovation Centre

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Other: Serum X

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

May 31, 2023Actual

Completion Date

Sep 1, 2023Actual

First Submitted Date

Jan 11, 2023

First Submission Date that Met QC Criteria

Jan 11, 2023

First Posted Date

Jan 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

The skin brightening effect of the product on facial skin.
To observe any adverse effect occurrence with the usage of the product.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Serum X	Experimental	Participants will used serum X twice daily for 12 weeks	Other: Other: Serum X

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Other: Serum X	Other	Serum X contain arbutin and glutathione	Serum X

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in skin tone from baseline and at week 4, week 8, and week 12 after usage of serum X.	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	Based on adverse effect occurrence on participants that occur during study period (12 weeks	Week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre		Petaling Jaya	Selangor	47810	Malaysia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided