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

Open-label, Prospective Study on 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.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation; Acne; Post-inflammatory Hyperpigmentation
• Intervention / Treatment: Other: Topical Cetyl Tranexamate Mesylate

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Cetyl Tranexamate Mesylate; Product will be used on the face twice daily in the morning and in the evening for 2 weeks.	Other: Topical Cetyl Tranexamate Mesylate; Topical product will be applied onto clean skin morning and night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial skin pigment intensity of 3 pre-identified lesions	Change in the appearance of pigment intensity (melanin measurement) of 3 pre-identified hyperpigmented lesions	2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Actera
• Investigators: Principal Investigator: Raja Sivamani, MD MS AP, Integrative Skin Science and Research

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: October 2, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: i23-01_CTM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No