HyperpigmentationNCT07067879
The Effectiveness of a Novel Lip Product Containing Caulerpa Lentillifera Extract for Reducing Lip Hyperpigmentation
A study testing Lip product in people with Hyperpigmentation, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of the novel lip product containing Caulerpa lentillifera extract on the appearance and perception of dark lips in Thai adults aged 18 to 60 who report concerns about darkened lips. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation
- What is being tested?
- Lip product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 23 Jul 2025to 13 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Understand the study protocol and provide informed consent after being informed of potential risks and benefits.
- Refrain from using any other lip products, including lipstick, lip gloss, or lip conditioners, during the study period.
Who cannot join
- Have a known allergy or sensitivity to cosmetic products or Caulerpa lentillifera.
- Are on medication one month prior to study commencement.
- Exhibit lip abnormalities such as malformation, inflammation, swelling, or sores.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Chulalongkorn university
Bangkok, 10330
Patteera Ongkosit, +66 843760275, phatprae@gmail.com
Paswach Wiriyakijja, Dr.
About this study
The goal of this clinical trial is to evaluate the efficacy of the novel lip product containing Caulerpa lentillifera extract on the appearance and perception of dark lips in Thai adults aged 18 to 60 who report concerns about darkened lips. The main question it aims to answer is: Can the novel lip product containing C. lentillifera extract will significantly improve the appearance and perception of dark lips in Thai adults by reducing hyperpigmentation compared to baseline measurements?
Participants will apply the lip product twice a day, in the morning after breakfast and before bedtime, and refrain from using other lip products throughout the clinical trial period (7 days).
Researchers will compare the result to baseline measurements
- Conditions
- Hyperpigmentation
- Being tested
- Lip product
- Keywords
- Lip hyperpigmentation, Seaweed, Antera3D, Lip care
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lip productOther
Lip product containing Caulerpa lentillifera extract
| Study group | Role | What they receive |
|---|---|---|
| Lip product application group | Experimental | Not described Receives: Other: Lip product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in improving lip hyperpigmentation
Lip hyperpigmentation is assessed using Antera3D at baseline and 7 day after usage
Measured: Baseline and 7 days
Secondary outcomes (2)
Change from baseline in improving lip dryness
Lip dryness is assessed using Fotofinder system at baseline and 7 day after usage
Measured: Baseline and 7 days
Subjective assessment by participants
Participants' evaluations will be collected through an online self-reported questionnaire. Subjective perceptions of lip color and dryness will be assessed using a 0-10 numerical darkness and dryness scale. Additionally, a satisfaction rating questionnaire will be administered to assess participant satisfaction with their lip appearance and the lip product on day 1 and day 7. The questionnaire will evaluate six key aspects of product performance;
- Overall satisfaction
- Effectiveness in hydration and moisturization
- Improvement in lip color and texture
- Ease of use and packaging design
- Sensory attributes such as texture and scent
- Occurrence of any adverse reactions
Measured: Baseline, day 1, and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start23 Jul 2025 (estimated)
- Primary completion13 Aug 2025 (estimated)
- Study completion13 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067879
- Sponsor's protocol ID
- HREC-DCU2025-037
- Status last verified
- Jun 2025
- First submitted
- 7 Jul 2025
- Last updated
- 16 Jul 2025
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Novel Lip Product Containing Caulerpa Lentillifera Extract for Reducing Lip Hyperpigmentation
- ClinicalTrials.gov ID
- NCT07067879
- Acronym / sponsor ID
- HREC-DCU2025-037
- Conditions
- Hyperpigmentation
- Keywords
- Lip hyperpigmentation, Seaweed, Antera3D, Lip care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 23 Jul 2025 (estimated)
- Primary completion
- 13 Aug 2025 (estimated)
- Study completion
- 13 Aug 2025 (estimated)
- First posted
- 16 Jul 2025 (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 efficacy of the novel lip product containing Caulerpa lentillifera extract on the appearance and perception of dark lips in Thai adults aged 18 to 60 who report concerns about darkened lips. The main question it aims to answer is: Can the novel lip product containing C. lentillifera extract will significantly improve the appearance and perception of dark lips in Thai adults by reducing hyperpigmentation compared to baseline measurements?
Participants will apply the lip product twice a day, in the morning after breakfast and before bedtime, and refrain from using other lip products throughout the clinical trial period (7 days).
Researchers will compare the result to baseline measurements
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lip product application group | Experimental | Other: Lip product |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Understand the study protocol and provide informed consent after being informed of potential risks and benefits.
- Refrain from using any other lip products, including lipstick, lip gloss, or lip conditioners, during the study period.
Key exclusion criteria (3 listed)
- Have a known allergy or sensitivity to cosmetic products or Caulerpa lentillifera.
- Are on medication one month prior to study commencement.
- Exhibit lip abnormalities such as malformation, inflammation, swelling, or sores.
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 |
|---|---|---|
| Lip productLip product containing Caulerpa lentillifera extract | Other | Lip product application group |
Primary outcome
Change from baseline in improving lip hyperpigmentation
Time frame: Baseline and 7 days
Lip hyperpigmentation is assessed using Antera3D at baseline and 7 day after usage
2 secondary outcomes
Change from baseline in improving lip dryness
Time frame: Baseline and 7 days
Subjective assessment by participants
Time frame: Baseline, day 1, and day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lip product in people with Hyperpigmentation, run by Chulalongkorn University at 1 site in Thailand.
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 3 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in improving lip hyperpigmentation (time frame: Baseline and 7 days). 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 16 Jul 2025.