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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2022-01-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Postinflammatory Hyperpigmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split-face study in which topical tranexamic acid will be applied to one side of the face and the other side of the face will be the placebo/vehicle as a control.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Right Side of Face

Patients will apply topical tranexamic acid to the dark spots on the one side of their face.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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

Left Side of Face

Patients will apply the vehicle cream without any medication to the dark spots on one side of their face.

Group Type SHAM_COMPARATOR

Vehicle

Intervention Type DRUG

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.

Interventions

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Tranexamic Acid

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

Intervention Type DRUG

Vehicle

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes