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

Phase 2

Withdrawn

• Conditions: Postinflammatory Hyperpigmentation
• Interventions: Drug: Vehicle; Drug: Tranexamic Acid

• Registration Number: NCT03361345
• Lead Sponsor: Wayne State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-04
• Study Start: 2018-11-01
• Primary Completion: 2022-01-09
• Study Completion: 2022-01-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Side of Face	Vehicle	Patients will apply the vehicle cream without any medication to the dark spots on one side of their face.
Right Side of Face	Tranexamic Acid	Patients will apply topical tranexamic acid to the dark spots on the one side of their face.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Pigmentation at 12 Weeks.	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.
Change from Baseline Pigmentation at 4 Weeks.	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.
Change from Baseline Pigmentation at 8 Weeks.	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.

Trial Locations

Locations (1)

WSUPG Dermatology; 🇺🇸 Dearborn, Michigan, United States