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

NCT06080035 | Completed

• 1 other identifier: i23-01_CTM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation; Post-inflammatory Hyperpigmentation; Acne

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Facial skin pigment intensity of 3 pre-identified lesions

  1 week

• Self-perception of skin pigmentation

  1 week

• Self-perception of skin pigmentation

  2 week

• Self-perception of skin redness

  1 week

• Self-perception of skin redness

  2 week

Study Arms (1)

Topical Cetyl Tranexamate Mesylate

EXPERIMENTAL

Product will be used on the face twice daily in the morning and in the evening for 2 weeks.

Other: Topical Cetyl Tranexamate Mesylate

Interventions

Topical Cetyl Tranexamate Mesylate OTHER

Topical product will be applied onto clean skin morning and night.

Topical Cetyl Tranexamate Mesylate

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integrative Skin Science and Research: lead
• Actera: collaborator

Study Sites (1)

Integrative Skin and Research

Sacramento, California, 95815, United States

Location

MeSH Terms

Conditions

Hyperpigmentation; Acne Vulgaris

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Acneiform Eruptions; Sebaceous Gland Diseases

Study Officials

• Raja Sivamani, MD MS AP

  Integrative Skin Science and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 12, 2023
• Study Start: November 6, 2023
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (1)