ClinicalTrials.gg
RecruitingNCT07067879Updated Jul 16, 2025

The Effectiveness of a Novel Lip Product Containing Caulerpa Lentillifera Extract for Reducing Lip Hyperpigmentation

An interventional study of Lip product in Hyperpigmentation, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Hyperpigmentation

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Keywords

  • Lip hyperpigmentation
  • Seaweed
  • Antera3D
  • Lip care
03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's planned enrollment of 30 is close to the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Understand the study protocol and provide 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Lip product application group

    Other: Lip product

Interventions

  • OtherLip product

    Lip product containing Caulerpa lentillifera extract

06

What researchers measure

Primary outcomes

  1. Change from baseline in improving lip hyperpigmentation

    Lip hyperpigmentation is assessed using Antera3D at baseline and 7 day after usage

    Time frame: Baseline and 7 days

Secondary outcomes

  1. Change from baseline in improving lip dryness

    Lip dryness is assessed using Fotofinder system at baseline and 7 day after usage

    Time frame: Baseline and 7 days

  2. 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; 1. Overall satisfaction 2. Effectiveness in hydration and moisturization 3. Improvement in lip color and texture 4. Ease of use and packaging design 5. Sensory attributes such as texture and scent 6. Occurrence of any adverse reactions

    Time frame: Baseline, day 1, and day 7

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2025; primary completion for Aug 2025, 0 months later.

Of 37 non-industry interventional studies with no phase under Hyperpigmentation, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 0 months is below that.

Counting every sponsor, half of 64 studies reached it within 7 months; a quarter within 3 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2025
First posted
Jul 16, 2025
StartEst.
Jul 23, 2025
Primary completionEst.
Aug 13, 2025
CompletionEst.
Aug 13, 2025
Last update
Jul 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07067879
Responsible party
Sponsor
First posted
Jul 16, 2025
Start date
Jul 23, 2025 (estimated)
Primary completion
Aug 13, 2025 (estimated)
Completion
Aug 13, 2025 (estimated)
Last update
Jul 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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