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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06080035
• Other study ID #: i23-01_CTM
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: Integrative Skin Science and Research
• Contact: Nhi P Nguyen, BS
• Phone: 9167502463
• Email: nhi[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 hypothedized to have greater permeability and this study will evaluate the effects of CTM on the appearance of post-inflammatory hyperpigmentation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: April 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne
• Hyperpigmentation
• Post-inflammatory Hyperpigmentation

Intervention

Other:
• Topical Cetyl Tranexamate Mesylate
Topical product will be applied onto clean skin morning and night.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Actera

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Self-perception of skin pigmentation	Survey-based self-assessment of facial skin pigmentation	1 week
Secondary	Self-perception of skin pigmentation	Survey-based self-assessment of facial skin pigmentation	2 week
Secondary	Self-perception of skin redness	Survey-based self-assessment of aspects of skin redness	1 week
Secondary	Self-perception of skin redness	Survey-based self-assessment of aspects of skin redness	2 week