HealthyNCT05657379
Effect of Moisturizer on Malaysian Women Facial Skin
A study testing Other: Product X moisturizer in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are: 1. The effect of Product X on skin hydration of middle-aged women in Malaysia. 2. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Other: Product X moisturizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Aug 2022to 30 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysian citizen
- Middle-aged woman (40-60 years old)
Who cannot join
- Participants taking isotretinoin
- Immunocompromised patients or participants with any skin diseases or diseases that may compromised the participants well-being and study outcome.
- Participant who undergo any cosmetic procedures such as laser \& light treatment for the past three months.
- Participant with a history of facial surgery.
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 Effect of Product X Moisturizer on Skin Texture of Middle-Aged Women in Malaysia
The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are:
- The effect of Product X on skin hydration of middle-aged women in Malaysia.
- The effect of Product X on skin elasticity of middle-aged women in Malaysia.
- The effect of Product X on skin wrinkle of middle-aged women in Malaysia.
- To observe any adverse effect occurrence with the use of Product X.
Participants will used Product X for 8 week and the skin assessment will be carried out at baseline, week 2, 4 and week 8.
- Conditions
- Healthy
- Being tested
- Other: Product X moisturizer
- Keywords
- Middle-aged women, moisturizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Product X moisturizerOther
Product X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water
| Study group | Role | What they receive |
|---|---|---|
| Product X moisturizer | Experimental | Participants will used Product X moisturizer twice daily for 8 weeks Receives: Other: Other: Product X moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X
Skin hydration will be assessed using JANUS III skin analyzer
Measured: Baseline, week 2, 4 and 8
Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X
Skin elasticity will be assessed using JANUS III skin analyzer
Measured: Baseline, week 2, 4 and 8
Change in skin wrinkles from baseline and at week 2, 4 and 8 after using Product X
Skin wrinkles will be assessed using JANUS III skin analyzer and Wrinkle Severity Rating Scale (WSRS). For WSRS, dermatologists will evaluate participants' wrinkles based on 5-point photonumeric rating scale that will objectively evaluate the severity of crow's feet at rest (static) and with a smiling expression (dynamic). The scale scores are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.
Measured: Baseline, week 2, 4 and 8
Adverse effect after using Product X
Based on adverse effect occurrence on participants that occur during study period (8 weeks)
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start15 Aug 2022
- Primary completion30 Sep 2023
- Study completion30 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
- 28 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
- NCT05657379
- Sponsor's protocol ID
- RMC/EC41/2022
- Status last verified
- Nov 2023
- First submitted
- 7 Dec 2022
- 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 Effect of Product X Moisturizer on Skin Texture of Middle-Aged Women in Malaysia
- ClinicalTrials.gov ID
- NCT05657379
- Acronym / sponsor ID
- RMC/EC41/2022
- Conditions
- Healthy
- Keywords
- Middle-aged women, moisturizer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- USMARI Research & Innovation CentreIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Dec 2022 (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.
The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are:
- The effect of Product X on skin hydration of middle-aged women in Malaysia.
- The effect of Product X on skin elasticity of middle-aged women in Malaysia.
- The effect of Product X on skin wrinkle of middle-aged women in Malaysia.
- To observe any adverse effect occurrence with the use of Product X.
Participants will used Product X for 8 week and the skin assessment will be carried out at baseline, week 2, 4 and week 8.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Product X moisturizer | Experimental | Other: Other: Product X moisturizerParticipants will used Product X moisturizer twice daily for 8 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Malaysian citizen
- Middle-aged woman (40-60 years old)
Key exclusion criteria (4 listed)
- Participants taking isotretinoin
- Immunocompromised patients or participants with any skin diseases or diseases that may compromised the participants well-being and study outcome.
- Participant who undergo any cosmetic procedures such as laser \& light treatment for the past three months.
- Participant with a history of facial surgery.
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: Product X moisturizerProduct X moisturizer containing Hyaluronic Acid and Rosa Damascena Flower Water | Other | Product X moisturizer |
Primary outcome
Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X
Time frame: Baseline, week 2, 4 and 8
Skin hydration will be assessed using JANUS III skin analyzer
Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X
Time frame: Baseline, week 2, 4 and 8
Skin elasticity will be assessed using JANUS III skin analyzer
Change in skin wrinkles from baseline and at week 2, 4 and 8 after using Product X
Time frame: Baseline, week 2, 4 and 8
Skin wrinkles will be assessed using JANUS III skin analyzer and Wrinkle Severity Rating Scale (WSRS). For WSRS, dermatologists will evaluate participants' wrinkles based on 5-point photonumeric rating scale that will objectively evaluate the severity of crow's feet at rest (static) and with a smiling expression (dynamic). The scale scores are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.
Adverse effect after using Product X
Time frame: Week 8
Based on adverse effect occurrence on participants that occur during study period (8 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: Product X moisturizer 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 4 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?
Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X (time frame: Baseline, week 2, 4 and 8). The study lists 4 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.