Status:

COMPLETED

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

Lead Sponsor:

Integrative Skin Science and Research

Collaborating Sponsors:

Actera

Conditions:

Hyperpigmentation

Post-inflammatory Hyperpigmentation

Eligibility:

All Genders

14-45 years

Phase:

NA

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. Hyperpigm...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 6 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 11 2024

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT06080035

Start Date

November 6 2023

End Date

January 11 2024

Last Update

August 28 2024

Active Locations (1)

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1

Integrative Skin and Research

Sacramento, California, United States, 95815