Study Results
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Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2016-02-22
2019-05-05
Brief Summary
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Detailed Description
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During the investigators previous study on an in-vivo model for post-inflammatory hyperpigmentation, the investigators investigated the clinical, spectroscopic and histologic characteristics of acne-induced PIH versus irritant induced PIH using Trichloroacetic acid (TCA), 35% solution. From this initial study, the investigators concluded that the similarity of Investigator's Global Assessment scores, and spectroscopic measurements using Diffuse Reflectance Spectroscopy and Colorimetry in both acne and TCA-induced PIH at Day 28 suggest that TCA-induced PIH could be a reproducible model for acne induced PIH.
Bakuchiol is a meroterpene phenol derived from plant sources, such as the leaves and seeds of Psoralea corylifolia and the fruits of Piper longum. It has been reported to have anti-inflammatory, anti-bacterial, and antioxidant properties, as well as cause improvement in photodamaged skin. In-vitro studies on melanin production showed that bakuchiol had inhibitory effects on melanin synthesis, which make it a promising therapeutic intervention in the management of PIH.
This study aims to evaluate the efficacy of bakuchiol in treating post inflammatory hyperpigmentation using the investigators previously validated model in comparison to acne induced PIH.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bakuchiol
Bakuchiol cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot
Bakuchiol
Apply bakuchiol cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days
Vehicle
Vehicle cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot
Vehicle
Apply vehicle cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days
Interventions
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Bakuchiol
Apply bakuchiol cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days
Vehicle
Apply vehicle cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days
Eligibility Criteria
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Inclusion Criteria
* Minimum age of 18 years
* Able to understand requirements of the study and risks involved
* Able to sign a consent form.
* Existing facial acne pustules (at least three on the face) with history of post-inflammatory hyperpigmentation
Exclusion Criteria
* Patients with a history of cystic acne or acne conglobate
* Patients on systemic antibiotics or keratolytics (isotretinoin, etc), or topical antibiotics or keratolytic use (retinoids, benzoyl peroxide) over target areas who are unwilling to stop these medications for the duration of the study.
18 Years
100 Years
ALL
Yes
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Iltefat Hamzavi
Senior Staff Physician
Principal Investigators
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Iltefat Hamzavi, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Hospital
Locations
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Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Detroit, Michigan, United States
Countries
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References
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Taylor S, Grimes P, Lim J, Im S, Lui H. Postinflammatory hyperpigmentation. J Cutan Med Surg. 2009 Jul-Aug;13(4):183-91. doi: 10.2310/7750.2009.08077.
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.
Baumann L, Rodriguez D, Taylor SC, Wu J. Natural considerations for skin of color. Cutis. 2006 Dec;78(6 Suppl):2-19.
Grimes PE, Stockton T. Pigmentary disorders in blacks. Dermatol Clin. 1988 Apr;6(2):271-81.
Chaudhuri RK, Bojanowski K. Bakuchiol: a retinol-like functional compound revealed by gene expression profiling and clinically proven to have anti-aging effects. Int J Cosmet Sci. 2014 Jun;36(3):221-30. doi: 10.1111/ics.12117. Epub 2014 Mar 6.
Polakova K, Fauger A, Sayag M, Jourdan E. A dermocosmetic containing bakuchiol, Ginkgo biloba extract and mannitol improves the efficacy of adapalene in patients with acne vulgaris: result from a controlled randomized trial. Clin Cosmet Investig Dermatol. 2015 Apr 10;8:187-91. doi: 10.2147/CCID.S81691. eCollection 2015.
Ohno O, Watabe T, Nakamura K, Kawagoshi M, Uotsu N, Chiba T, Yamada M, Yamaguchi K, Yamada K, Miyamoto K, Uemura D. Inhibitory effects of bakuchiol, bavachin, and isobavachalcone isolated from Piper longum on melanin production in B16 mouse melanoma cells. Biosci Biotechnol Biochem. 2010;74(7):1504-6. doi: 10.1271/bbb.100221. Epub 2010 Jul 7.
Other Identifiers
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IRB #9920 Protocol 2
Identifier Type: -
Identifier Source: org_study_id
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