HealthyNCT05693948
The Efficacy of Topical Serum X for Skin Brightening
A study testing Other: Serum X in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Other: Serum X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysia citizen
- Male and female (age 18-30 years old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Petaling Jaya, Selangor, 47810
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Other: Serum X
- Keywords
- Aesthetic, Cosmetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Serum XOther
Serum X contain arbutin and glutathione
| Study group | Role | What they receive |
|---|---|---|
| Serum X | Experimental | Participants will used serum X twice daily for 12 weeks Receives: Other: Other: Serum X |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Sep 2022
- Primary completion31 May 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- USMARI Research & Innovation Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693948
- Sponsor's protocol ID
- UMRAMREC001-22
- Status last verified
- Nov 2023
- First submitted
- 11 Jan 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Topical Serum X Containing Arbutin and Glutathione for Skin Brightening
- ClinicalTrials.gov ID
- NCT05693948
- Acronym / sponsor ID
- UMRAMREC001-22
- Conditions
- Healthy
- Keywords
- Aesthetic, Cosmetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- USMARI Research & Innovation CentreIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serum X | Experimental | Other: Other: Serum XParticipants will used serum X twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Malaysia citizen
- Male and female (age 18-30 years old)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Serum XSerum X contain arbutin and glutathione | Other | Serum X |
Primary outcome
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
Adverse effect after using serum X
Time frame: Week 12
Based on adverse effect occurrence on participants that occur during study period (12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Other: Serum X in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.