Clinical trial NCT03361345: Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris
Official title: Topical 5% Tranexamic Acid as a Treatment for Postinflammatory Hyperpigmentation Due to Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Postinflammatory Hyperpigmentation
Keywords: Postinflammatory hyperpigmentation
Acne
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Pigmentation at 4 Weeks.
timeFrame: 4 Weeks.
measure: Change from Baseline Pigmentation at 8 Weeks.
timeFrame: 8 Weeks
measure: Change from Baseline Pigmentation at 12 Weeks.
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: WSUPG Dermatology
state: Michigan
Study officials:
affiliation: WSUPG Dermatology
name: Steven Daveluy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis EC, Callender VD. Postinflammatory hyperpigmentation: a review of the epidemiology, clinical features, and treatment options in skin of color. J Clin Aesthet Dermatol. 2010 Jul;3(7):20-31.
citation: Darji K, Varade R, West D, Armbrecht ES, Guo MA. Psychosocial Impact of Postinflammatory Hyperpigmentation in Patients with Acne Vulgaris. J Clin Aesthet Dermatol. 2017 May;10(5):18-23. Epub 2017 May 1.
citation: Atefi N, Dalvand B, Ghassemi M, Mehran G, Heydarian A. Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma. Dermatol Ther (Heidelb). 2017 Sep;7(3):417-424. doi: 10.1007/s13555-017-0195-0. Epub 2017 Jul 26.
citation: Kim SJ, Park JY, Shibata T, Fujiwara R, Kang HY. Efficacy and possible mechanisms of topical tranexamic acid in melasma. Clin Exp Dermatol. 2016 Jul;41(5):480-5. doi: 10.1111/ced.12835. Epub 2016 May 2.
citation: Na JI, Choi SY, Yang SH, Choi HR, Kang HY, Park KC. Effect of tranexamic acid on melasma: a clinical trial with histological evaluation. J Eur Acad Dermatol Venereol. 2013 Aug;27(8):1035-9. doi: 10.1111/j.1468-3083.2012.04464.x. Epub 2012 Feb 13.
citation: Ebrahimi B, Naeini FF. Topical tranexamic acid as a promising treatment for melasma. J Res Med Sci. 2014 Aug;19(8):753-7.
citation: Savory SA, Agim NG, Mao R, Peter S, Wang C, Maldonado G, Bearden Dietert J, Lieu TJ, Wang C, Pretzlaff K, Das S, Vandergriff T, Lopez IE, Litzner BR, Hynan LS, Arellano-Mendoza MI, Bergstresser PR, Pandya AG. Reliability assessment and validation of the postacne hyperpigmentation index (PAHPI), a new instrument to measure postinflammatory hyperpigmentation from acne vulgaris. J Am Acad Dermatol. 2014 Jan;70(1):108-14. doi: 10.1016/j.jaad.2013.09.017. Epub 2013 Oct 28.