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

Not Applicable

Completed

• Conditions: Hyperpigmentation; Post-inflammatory Hyperpigmentation; Acne
• Interventions: Other: Topical Cetyl Tranexamate Mesylate

• Registration Number: NCT06080035
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Study Start: 2023-11-06
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical Cetyl Tranexamate Mesylate	Topical Cetyl Tranexamate Mesylate	Product will be used on the face twice daily in the morning and in the evening for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Facial skin pigment intensity of 3 pre-identified lesions	2 weeks	Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions

Secondary Outcome Measures

Name	Time	Method
Self-perception of skin pigmentation	2 week	Survey-based self-assessment of facial skin pigmentation
Self-perception of skin redness	2 week	Survey-based self-assessment of aspects of skin redness
Facial skin pigment intensity of 3 pre-identified lesions	1 week	Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions

Trial Locations

Locations (1)

Integrative Skin and Research; 🇺🇸 Sacramento, California, United States