Postinflammatory Hyperpigmentation
Conditions
Keywords
Postinflammatory hyperpigmentation, Acne
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.
Interventions
DRUGTranexamic Acid
Topical tranexamic acid in cream form applied to dark spots on right side of face.
DRUGVehicle
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.
Sponsors
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed