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

Study Overview
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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.

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

Conditions
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Postinflammatory Hyperpigmentation

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Vehicle


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right Side of Face<br>Patients will apply topical tranexamic acid to the dark spots on the one side of their face. | Drug: Tranexamic Acid<br>* Topical tranexamic acid in cream form applied to dark spots on right side of face.<br>|
| Sham Comparator: Left Side of Face<br>Patients will apply the vehicle cream without any medication to the dark spots on one side of their face. | Drug: Vehicle<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postinflammatory hyperpigmentation, Acne