The Efficacy of Bakuchiol in Treating PIH

NCT06833996 | Completed

• 1 other identifier: IRB #9920 Protocol 2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Inflammatory Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• 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 1. Almost clear of hyperpigmentation 2. Mild, but noticeable hyperpigmentation 3. Moderate hyperpigmentation (medium brown in quality) 4. Severe hyperpigmentation (dark brown in quality) 5. Very severe hyperpigmentation (very dark brown, almost black in quality)

  56 days

Study Arms (2)

Bakuchiol

EXPERIMENTAL

Bakuchiol cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot

Drug: Bakuchiol

Vehicle

PLACEBO COMPARATOR

Vehicle cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot

Drug: Vehicle

Interventions

Bakuchiol DRUG

Apply bakuchiol cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days

Bakuchiol

Vehicle DRUG

Apply vehicle cream twice daily to a select acne induced and TCA induced PIH spot for a total of 28 days

Vehicle

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with types IV-VI skin
• 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

You may not qualify if:

• Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of PIH judged to be clinically significant by the investigator
• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Detroit, Michigan, 48202, United States

Location

Related Publications (7)

• 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.

  PMID: 19706225 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.

  PMID: 20725554 BACKGROUND

• Baumann L, Rodriguez D, Taylor SC, Wu J. Natural considerations for skin of color. Cutis. 2006 Dec;78(6 Suppl):2-19.

  PMID: 17354519 BACKGROUND

• Grimes PE, Stockton T. Pigmentary disorders in blacks. Dermatol Clin. 1988 Apr;6(2):271-81.

  PMID: 3378372 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.

  PMID: 24471735 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.

  PMID: 25914553 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.

  PMID: 20622433 BACKGROUND

MeSH Terms

Conditions

Hyperpigmentation

Interventions

bakuchiol

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Iltefat Hamzavi, MD

  Henry Ford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: February 19, 2025
• Study Start: February 22, 2016
• Primary Completion: May 23, 2018
• Study Completion: May 5, 2019
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)