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NCT Number: NCT07067879

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

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

Recruiting

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Key information

Conditions

Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Chulalongkorn university

Bangkok, 10330, Thailand

Location status: Recruiting

Location contact

Paswach Wiriyakijja, Dr.

CONTACT

Patteera Ongkosit

CONTACT

[email protected]

+66 843760275

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Lip product

Other

Lip product containing Caulerpa lentillifera extract

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline in improving lip dryness

    Time frame: Baseline and 7 days

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

  2. Subjective assessment by participants

    Time frame: Baseline, day 1, and day 7

    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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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