NCT07067879

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 23, 2025

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2025

Completed
Last Updated

July 16, 2025

Status Verified

June 1, 2025

Enrollment Period

21 days

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

Lip hyperpigmentationSeaweedAntera3DLip care

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in improving lip hyperpigmentation

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

    Baseline and 7 days

Secondary Outcomes (2)

  • Change from baseline in improving lip dryness

    Baseline and 7 days

  • Subjective assessment by participants

    Baseline, day 1, and day 7

Study Arms (1)

Lip product application group

EXPERIMENTAL
Other: Lip product

Interventions

Lip product containing Caulerpa lentillifera extract

Lip product application group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Chulalongkorn university

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

July 23, 2025

Primary Completion

August 13, 2025

Study Completion

August 13, 2025

Last Updated

July 16, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations