AestheticNCT05694442
The Effect of Lipmatte K
A study testing Lipmatte K in people with Aesthetic and Cosmetic, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial summary
This study is conducted to evaluate the safety and the effectiveness of Lipmatte K on lip hydration and brightening. The study duration is 4 weeks and the lip assessment will be carried out at baseline, week 2 and week 4.The main questions this study aims to answer are: 1. The hydration effect of the product on lip. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- What is being tested?
- Lipmatte K
- 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 Mar 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysia citizen
- Female (age 30-55 years old)
- Lip with mild-to-moderate dryness
Who cannot join
- Subjects who have history of performing lips-related treatments such as lip augmentation (filler, botox, laser)
- Heavy lips desquamation or chapped lip conditions
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 Lipmatte K on Lip Hydration and Brightening
This study is conducted to evaluate the safety and the effectiveness of Lipmatte K on lip hydration and brightening. The study duration is 4 weeks and the lip assessment will be carried out at baseline, week 2 and week 4.The main questions this study aims to answer are:
- The hydration effect of the product on lip.
- The brightening effect of the product on lip.
- To observe any adverse effect occurrence with the usage of the product.
- Being tested
- Lipmatte K
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipmatte KOther
Lipmatte K contain ingredients that may hydrate and brighten the lip
| Study group | Role | What they receive |
|---|---|---|
| Lipmatte K | Experimental | Participants will used Lipmatte K everyday for 4 weeks Receives: Other: Lipmatte K |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lip roughness from baseline and at week 2 and 4 after using Lipmatte K
Degree of lip roughness for each participant's will be determined by dermatologist based on score 0 to 2 (0= no desquamations, 1 = slight desquamations and 2 = heavy desquamations)
Measured: Baseline, Week 2, Week 4
Change in lip wrinkles from baseline and at week 2 and 4 after using Lipmatte K
Degree of lip wrinkle for each participant's will be determined by dermatologist based on score 0- 2 (0 = no/almost no vertical wrinkles, 1 = no deep vertical wrinkles and 2 = many deep vertical wrinkles)
Measured: Baseline, Week 2, Week 4
Visual assessment of the lip from baseline and at week 2 and 4 after using Lipmatte K
Image of the lip will be captured using digital camera (Nikon D5100) to observed the brightening effect of the lipmatte
Measured: Baseline, Week 2, Week 4
Adverse effect after using Lipmatte K
Based on adverse effect occurrence on participants that occur during study period (4 weeks)
Measured: Week 4
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 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AestheticStudies 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
- NCT05694442
- Sponsor's protocol ID
- UMRAMREC002-22
- Status last verified
- May 2023
- First submitted
- 12 Jan 2023
- Last updated
- 11 May 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lipmatte K on Lip Hydration and Brightening
- ClinicalTrials.gov ID
- NCT05694442
- Acronym / sponsor ID
- UMRAMREC002-22
- 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 Dec 2022 (actual)
- Study completion
- 1 Mar 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 safety and the effectiveness of Lipmatte K on lip hydration and brightening. The study duration is 4 weeks and the lip assessment will be carried out at baseline, week 2 and week 4.The main questions this study aims to answer are:
- The hydration effect of the product on lip.
- The brightening effect of the product on lip.
- 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 |
|---|---|---|
| Lipmatte K | Experimental | Other: Lipmatte KParticipants will used Lipmatte K everyday for 4 weeks |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Malaysia citizen
- Female (age 30-55 years old)
- Lip with mild-to-moderate dryness
Key exclusion criteria (2 listed)
- Subjects who have history of performing lips-related treatments such as lip augmentation (filler, botox, laser)
- Heavy lips desquamation or chapped lip conditions
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 |
|---|---|---|
| Lipmatte KLipmatte K contain ingredients that may hydrate and brighten the lip | Other | Lipmatte K |
Primary outcome
Change in lip roughness from baseline and at week 2 and 4 after using Lipmatte K
Time frame: Baseline, Week 2, Week 4
Degree of lip roughness for each participant's will be determined by dermatologist based on score 0 to 2 (0= no desquamations, 1 = slight desquamations and 2 = heavy desquamations)
Change in lip wrinkles from baseline and at week 2 and 4 after using Lipmatte K
Time frame: Baseline, Week 2, Week 4
Degree of lip wrinkle for each participant's will be determined by dermatologist based on score 0- 2 (0 = no/almost no vertical wrinkles, 1 = no deep vertical wrinkles and 2 = many deep vertical wrinkles)
Visual assessment of the lip from baseline and at week 2 and 4 after using Lipmatte K
Time frame: Baseline, Week 2, Week 4
Image of the lip will be captured using digital camera (Nikon D5100) to observed the brightening effect of the lipmatte
Adverse effect after using Lipmatte K
Time frame: Week 4
Based on adverse effect occurrence on participants that occur during study period (4 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 11 May 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 Lipmatte K in people with Aesthetic and Cosmetic, 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 3 inclusion and 2 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 11 May 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 lip roughness from baseline and at week 2 and 4 after using Lipmatte K (time frame: Baseline, Week 2, Week 4). 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 11 May 2023.