Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris

Wayne State University

Overview

The goal of this study is to determine if topical tranexamic acid is capable of decreasing the pigment of the dark spots left from acne bumps. The first line medication used for this often is not tolerated well by patients, and topical tranexamic acid has minimal reported side effects thus far.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Postinflammatory Hyperpigmentation

Interventions

Tranexamic AcidDRUG

Topical tranexamic acid in cream form applied to dark spots on right side of face.

VehicleDRUG

The Vehicle is going to be a cream without any active medication that will be applied as a control substance for the topical tranexamic acid cream, and will be applied to the contralateral side of the face.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 65 * Patients with bilateral involvement of facial postinflammatory hyperpigmentation due to acne vulgaris. Exclusion Criteria: * Pregnant patients or patients planning to become pregnant during the time of the study. * Patients with a history of use of hydroquinone, kojic acid, tretinoin, adapalene, tazarotene or azaleic acid in the previous 3 months.

Locations (1)

WSUPG Dermatology

Dearborn, Michigan, United States

Outcomes

Primary Outcomes

Change from Baseline Pigmentation at 4 Weeks.

Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 4 weeks. The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.

Time frame: 4 Weeks.

Change from Baseline Pigmentation at 8 Weeks.

Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 8 weeks. The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.

Time frame: 8 Weeks

Change from Baseline Pigmentation at 12 Weeks.

Patients will have their lesion pigmentation scored with the postacne hyperpigmentation index after 12 weeks. The postacne hyperpigmentation index (PAHPI) assesses hyperpigmentation lesions after acne based on the median lesion size, the median lesion intensity, and the number of lesions present. The total score can range from 6-22 points. Subscales will measure lesion size, lesion intensity, and number of lesions. Subscales will be assigned a number based on the table in the protocol, and then added together to form the total score. Higher values indicate worse hyperpigmentation. We will measure the total decrease in the PAHPI at the follow-up visit.

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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