Clinical trial NCT06080035: The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
Official title: Open-label, Prospective Study on the Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperpigmentation
Post-inflammatory Hyperpigmentation
Acne
Lead sponsor: Integrative Skin Science and Research
Sponsor class: INDUSTRY
Collaborators: name: Actera
First posted: 2023-10-12
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Facial skin pigment intensity of 3 pre-identified lesions
timeFrame: 2 weeks
Secondary outcomes:
measure: Facial skin pigment intensity of 3 pre-identified lesions
timeFrame: 1 week
measure: Self-perception of skin pigmentation
timeFrame: 1 week
measure: Self-perception of skin pigmentation
timeFrame: 2 week
measure: Self-perception of skin redness
timeFrame: 1 week
measure: Self-perception of skin redness
timeFrame: 2 week
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin and Research
state: California
Study officials:
affiliation: Integrative Skin Science and Research
name: Raja Sivamani, MD MS AP
role: PRINCIPAL_INVESTIGATOR
References: