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Post-inflammatory hyperpigmentation (PIH) is an acquired hyper melanosis that occurs after cutaneous inflammation or injury frequently affecting darker skinned individuals. Bakuchiol is derived from plants and has inhibitory effects on melanin synthesis, which makes 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.
Post inflammatory hyperpigmentation (PIH) is an acquired hyper melanosis that occurs after cutaneous inflammation or injury. This process can occur in all skin types but more frequently affects darker skinned patients, such as African Americans, Hispanics, Asians, Native Americans, Pacific Islanders and those of Middle Eastern descent. PIH can occur after infection, allergic reactions, contact dermatitis, some medications, burns, following procedures, or inflammatory disease such as acne. In skin of color, PIH frequently occurs in resolving acne lesions and can persist for months after the acne lesion itself has disappeared. In many cases, the resulting PIH can be more distressing than the original insult.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bakuchiol | Experimental | Bakuchiol cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot |
|
| Vehicle | Placebo Comparator | Vehicle cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bakuchiol | Drug | Apply bakuchiol cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The degree of hyperpigmentation after treatment with bakuchiol | Pigment will be determined using an Investigators Global Assessment scale IGA Hyperpigmentation Description of Hyperpigmentation 0 Clear of hyperpigmentation
| 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iltefat Hamzavi, MD | Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard, | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19706225 | Background | 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. | |
| 20725554 | Background | 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. |
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| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C012765 | bakuchiol |
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| Vehicle | Drug | Apply vehicle cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days |
|
| 17354519 | Background | Baumann L, Rodriguez D, Taylor SC, Wu J. Natural considerations for skin of color. Cutis. 2006 Dec;78(6 Suppl):2-19. |
| 3378372 | Background | Grimes PE, Stockton T. Pigmentary disorders in blacks. Dermatol Clin. 1988 Apr;6(2):271-81. |
| 24471735 | Background | 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. |
| 25914553 | Background | 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. |
| 20622433 | Background | 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. |