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OpenTrials
Completed

NCT Number: NCT06080035

The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation

The purpose of this study is to assess the effects of Cetyl Tranexamate Mesylate on acne-related hyperpigmentation through a specific delivery form known as TeraCeutic TXVector.

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Key information

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Skin and Research

Sacramento, California, 95815, United States

About this study

Hyperpigmentation is characterized as an increase in pigment on the skin and is a common skin condition in individuals with skin types III to VI on the Fitzpatrick skin classification scale. Hyperpigmentation can be localized to an area in the form of post-inflammatory hyperpigmentation or diffused in the form of melasma. One of the treatments that are used to treat hyperpigmentation is tranexamic acid (TXA) which is a third-generation bioactive and is formally known to work as a plasmin inhibitor. Since TXA is hydrophilic in nature and has a strong hydrogen-bonding capacity, it has an insufficient skin permeability. Similar to TXA esters, Cetyl Tranexamate Mesylate (CTM) is hypothesized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females between the ages of 14 years of age until 55 years of age
  • Individuals experiencing 3 different areas minimum of facial post-inflammatory hyperpigmentation in those with acne

Exclusion criteria

  • Individuals who are pregnant or breastfeeding.
  • Prisoners.
  • Adults unable to consent.
  • Those who are unwilling to discontinue hydroquinone, vitamin A/C/E, azelaic acid, kojic acid, bakuchiol, licorice root, retinol, niacinamide, alpha arbutin, and oral or topical tranexamic acid for two weeks to meet the washout criteria prior to enrolling and for the duration of the study.
  • Subjects with any of the following facial cosmetic treatments within the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, or any other medical treatment administered by a physician or skin care professional which is designed to improve skin pigmentation.
  • Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
  • Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.

Treatment and study plan

Topical Cetyl Tranexamate Mesylate

Other

Topical product will be applied onto clean skin morning and night.

Primary outcomes

  1. Facial skin pigment intensity of 3 pre-identified lesions

    Time frame: 2 weeks

    Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions

Secondary outcomes

  1. Facial skin pigment intensity of 3 pre-identified lesions

    Time frame: 1 week

    Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions

  2. Self-perception of skin pigmentation

    Time frame: 1 week

    Survey-based self-assessment of facial skin pigmentation

  3. Self-perception of skin pigmentation

    Time frame: 2 week

    Survey-based self-assessment of facial skin pigmentation

  4. Self-perception of skin redness

    Time frame: 1 week

    Survey-based self-assessment of aspects of skin redness

  5. Self-perception of skin redness

    Time frame: 2 week

    Survey-based self-assessment of aspects of skin redness

Sponsors and collaborators

Lead sponsor

Integrative Skin Science and Research

Industry

Collaborators

  • Actera

Registry information

Official study title

Open-label, Prospective Study on the Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2023
Registry last updated
Aug 28, 2024

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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