HealthyNCT05691413
Safety and Efficacy of Facial Cleanser
A study testing Other: Product X facial cleanser in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial summary
This study is conducted to evaluate the safety and effectiveness of facial cleanser X containing combination of olive oil, virgin coconut oil, butylene glycol and hyaluronic acid on skin hydration and skin elasticity. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Other: Product X facial cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysia citizen
- Male and female (age 35-55 years old)
Who cannot join
- Participants who have acne which require medical treatment.
- Participants taking isotretinoin
- Participants who had undergo any cosmetic procedures such as laser \& light treatment, botulinum toxin A injections and chemical peeling for the past 3 months
- Participants who are immunocompromised
- Participants with 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 Safety and Efficacy of Facial Cleanser Containing Combination of Olive Oil, Virgin Coconut Oil, Butylene Glycol and Hyaluronic Acid on Skin Hydration and Skin Elasticity
This study is conducted to evaluate the safety and effectiveness of facial cleanser X containing combination of olive oil, virgin coconut oil, butylene glycol and hyaluronic acid on skin hydration and skin elasticity. The study duration is 5 weeks and the skin assessment will be carried out at baseline, week 3 and week 5.The main questions this study aims to answer are:
- The effect of product on skin hydration.
- The effect of product on skin elasticity.
- To observe any adverse effect occurrence with the usage of the product.
- Conditions
- Healthy
- Being tested
- Other: Product X facial cleanser
- Keywords
- Aesthetic, Cosmetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Product X facial cleanserOther
Product X facial cleanser contain olive oil, virgin coconut oil, butylene glycol and hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Product X facial cleanser | Experimental | Participants will used Product X facial cleanser twice daily for 5 weeks Receives: Other: Other: Product X facial cleanser |
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 3 and 5 after using facial cleanser X
Skin hydration will be assessed using JANUS III skin analyzer
Measured: Baseline, week 3 and week 5
Change in skin elasticity from baseline and at week 3 and 5 after using facial cleanser X
Skin elasticity will be assessed using JANUS III skin analyzer
Measured: Baseline, week 3 and week 5
Adverse effect after using facial cleanser X
Based on adverse effect occurrence on participants that occur during study period (5 weeks)
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Dec 2022
- Primary completion31 Aug 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
- 30 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
- NCT05691413
- Sponsor's protocol ID
- UMRAMREC004-22
- Status last verified
- Nov 2023
- First submitted
- 10 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 Safety and Efficacy of Facial Cleanser Containing Combination of Olive Oil, Virgin Coconut Oil, Butylene Glycol and Hyaluronic Acid on Skin Hydration and Skin Elasticity
- ClinicalTrials.gov ID
- NCT05691413
- Acronym / sponsor ID
- UMRAMREC004-22
- Conditions
- Healthy
- Keywords
- Aesthetic, Cosmetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- USMARI Research & Innovation CentreIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 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 safety and effectiveness of facial cleanser X containing combination of olive oil, virgin coconut oil, butylene glycol and hyaluronic acid on skin hydration and skin elasticity. The study duration is 5 weeks and the skin assessment will be carried out at baseline, week 3 and week 5.The main questions this study aims to answer are:
- The effect of product on skin hydration.
- The effect of product on skin elasticity.
- 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 |
|---|---|---|
| Product X facial cleanser | Experimental | Other: Other: Product X facial cleanserParticipants will used Product X facial cleanser twice daily for 5 weeks |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Malaysia citizen
- Male and female (age 35-55 years old)
Key exclusion criteria (5 listed)
- Participants who have acne which require medical treatment.
- Participants taking isotretinoin
- Participants who had undergo any cosmetic procedures such as laser \& light treatment, botulinum toxin A injections and chemical peeling for the past 3 months
- Participants who are immunocompromised
- Participants with 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 facial cleanserProduct X facial cleanser contain olive oil, virgin coconut oil, butylene glycol and hyaluronic acid | Other | Product X facial cleanser |
Primary outcome
Change in skin hydration from baseline and at week 3 and 5 after using facial cleanser X
Time frame: Baseline, week 3 and week 5
Skin hydration will be assessed using JANUS III skin analyzer
Change in skin elasticity from baseline and at week 3 and 5 after using facial cleanser X
Time frame: Baseline, week 3 and week 5
Skin elasticity will be assessed using JANUS III skin analyzer
Adverse effect after using facial cleanser X
Time frame: Week 5
Based on adverse effect occurrence on participants that occur during study period (5 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 facial cleanser 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 5 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 3 and 5 after using facial cleanser X (time frame: Baseline, week 3 and week 5). The study lists 3 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.