Human Clinical Trials Using Topical Bakuchiol Formulations for the Treatment of Skin Disorders: A Systematic Review

April 2024 | Volume 23 | Issue 4 | 239 | Copyright © April 2024


Published online March 28, 2024

doi:10.36849/JDD.7763

James E. Fanning BSa, Shayan A. McGee MD MSb, Omer I. Ibrahim MD FAADc

aDivision of Plastic and Reconstructive Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
bDepartment of Plastic and Reconstructive Surgery, Dartmouth-Hitchcock Medical Center, Hanover, NH 
cChicago Cosmetic Surgery and Dermatology, Chicago, IL

Abstract
Background: Bakuchiol is a topical cosmeceutical marketed as a retinoid alternative. Human clinical trial data on bakuchiol's efficacy for the treatment of dermatologic conditions has not been thoroughly evaluated.
Objective: To review human clinical trials using topical formulations containing bakuchiol in the treatment of facial skin disorders.
Materials and Methods: A comprehensive electronic search of Cochrane Library, PubMed, EMBASE, and Web of Science was conducted on August 28, 2022, using the search terms "bakuchiol" and "UP256." Study characteristics, measured outcomes, significant results, and stated limitations were extracted. 
Results: Fifteen human clinical trials were analyzed. Dermatologic conditions treated included aging, acne, and post-inflammatory hyperpigmentation. Twelve trials were unblinded, open-label trials without a control group. Ten trials used a combination therapy containing bakuchiol. Four trials did not specify the dose or concentration of bakuchiol in treatment regimens. The heterogeneity of treatments, study designs, and measured outcomes makes meta-analysis unfeasible. 
Conclusion: Trials lack methodologic rigor, which introduces a high risk of bias in reported outcomes. The use of combination topical formulations containing bakuchiol limits the comparison of bakuchiol's efficacy with retinoids. Continued research with an improved trial design is needed.

J Drugs Dermatol. 2024;23(4):239-243. doi:10.36849/JDD.7763

INTRODUCTION

The increasing role of online information in patient decision-making requires that dermatologists be prepared to discuss unsubstantiated dermatologic treatments that patients encounter online.1-4 An Instagram analysis found that 68% of influencers with over 40,000 followers who post dermatology-related content have no medical credentials, while only 4% were dermatologists.5 With 93% of skin influencers sharing self-promoted or sponsored content, there is substantial capacity for financial conflicts of interest.5 

These trends have been accompanied by an increased interest in natural skincare ingredients.6,7 Bakuchiol is a plant-derived molecule marketed as a natural, mild alternative to retinoids with demonstrated anti-tumor and anti-viral activity. Bakuchiol has been tested in epithelial carcinoma and melanoma cell lines, inhibits melanogenesis in cultured human melanocytes, and has been explored as a treatment for psoriasis.8-12 Bakuchiol's biologic activity is superficially understood but may be due to the modulation of inflammation and oxidation.13-19 Methodologic flaws in human clinical trials using bakuchiol for the treatment of facial aging have been reported.20 A recent review of evidence for bakuchiol's use in dermatology did not capture multiple published human clinical trials.21

The objective of this systematic review is an updated analysis comprising all human clinical trial data on the use of bakuchiol in topical formulations for the treatment of facial skin disorders. A broad assessment of evidence for bakuchiol's use as a dermatological treatment will inform its future use in cosmetic dermatology. 

MATERIALS AND METHODS

A comprehensive search of Cochrane Library, PubMed/MEDLINE, EMBASE, and Web of Science was conducted on or before August 28, 2022, using the search terms "bakuchiol" and "UP256." Cochrane Library PRISMA guidelines were used for de-duplication, inclusion, and exclusion processes.22,23 Inclusion criteria were human clinical trials with bakuchiol treatment of skin and English language. Exclusion criteria were basic science articles, epidemiologic studies, case reports, reviews, meta-analyses, skin explant studies, skin cell assay studies,