The Efficacy of Bakuchiol in Treating PIH

Not Applicable

Completed

• Conditions: Post Inflammatory Hyperpigmentation
• Interventions: Drug: Bakuchiol; Drug: Vehicle

• Registration Number: NCT06833996
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-02-22
• Study First Submitted: 2016-09-14
• Primary Completion: 2018-05-23
• Study Completion: 2019-05-05
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bakuchiol	Bakuchiol	Bakuchiol cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot
Vehicle	Vehicle	Vehicle cream to be applied to a select acne induced PIH spot and a select TCA induced PIH spot

Primary Outcome Measures

Name	Time	Method
The degree of hyperpigmentation after treatment with bakuchiol	56 days	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)

Trial Locations

Locations (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,; 🇺🇸 Detroit, Michigan, United States