INTRODUCTION
Acne vulgaris, or acne, is a common skin condition that affects approximately 10% of the global population.1 Despite their efficacy, many acne medications are irritating, decreasing adherence to therapy. Treatment-related cutaneous irritation is particularly relevant in patients with skin of color, who are susceptible to developing post-inflammatory hyperpigmentation (PIH)2,3 that frequently causes greater distress than acne itself.2,4,5
Bakuchiol, a meroterpene phenol found in the seeds of the herb Psoralea corylifolia as well as other plant sources, has been reported to possess a broad range of antimicrobial, anti-inflammatory, antioxidant, and estrogen-like properties.6 In the skin, bakuchiol has been primarily studied in combination with other ingredients for the treatment of facial photodamage.7,8 A single study previously assessed the efficacy of a product containing bakuchiol, Ginkgo biloba extract, and mannitol as an adjunct to adapalene 0.1% gel for the treatment of mild to moderate acne.9 This product was further shown to reduce the secretion of inflammatory cytokines IL-8 and TNFα in skin explants, while bakuchiol itself was able to inhibit the growth of Cutibacterium acnes (C. acnes) in vitro.10 Thus, bakuchiol potentially targets two important aspects of acne pathogenesis, namely, C. acnes proliferation and inflammation; however, the effectiveness of bakuchiol monotherapy has not previously been evaluated. Here we demonstrate the safety, tolerability, and efficacy of UP256, a novel cream formulation of bakuchiol 0.5%, in mild to moderate acne using a cohort highly enriched for skin of color patients.
Bakuchiol, a meroterpene phenol found in the seeds of the herb Psoralea corylifolia as well as other plant sources, has been reported to possess a broad range of antimicrobial, anti-inflammatory, antioxidant, and estrogen-like properties.6 In the skin, bakuchiol has been primarily studied in combination with other ingredients for the treatment of facial photodamage.7,8 A single study previously assessed the efficacy of a product containing bakuchiol, Ginkgo biloba extract, and mannitol as an adjunct to adapalene 0.1% gel for the treatment of mild to moderate acne.9 This product was further shown to reduce the secretion of inflammatory cytokines IL-8 and TNFα in skin explants, while bakuchiol itself was able to inhibit the growth of Cutibacterium acnes (C. acnes) in vitro.10 Thus, bakuchiol potentially targets two important aspects of acne pathogenesis, namely, C. acnes proliferation and inflammation; however, the effectiveness of bakuchiol monotherapy has not previously been evaluated. Here we demonstrate the safety, tolerability, and efficacy of UP256, a novel cream formulation of bakuchiol 0.5%, in mild to moderate acne using a cohort highly enriched for skin of color patients.
MATERIALS AND METHODS
Patients and Study Design
Male and female individuals between the ages of 12 and 30 years old with 6-point Investigator’s Global Assessment (IGA) scores indicating mild (IGA=2) or moderate (IGA=3) facial acne vulgaris were eligible to enroll in this study. Eligible participants were required to have 10–40 inflammatory lesions (papules, pustules, and nodules), 10–40 non-inflammatory lesions (closed and open comedones), and <2 facial cystic lesions. Main exclusion criteria included acne conglobata, acne fulminans, nodulocystic acne, and hormonal acne. A urine pregnancy test was required for female subjects at the screening and each study visit. In addition, washout periods of 14 days for topical acne medications, 30 days for oral antibiotics and investigational drugs, and 6 months for isotretinoin were also required. Prior to enrolling participants, the study protocol was approved by the Institutional Review Board at SUNY-Downstate Health Sciences University. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practices (GCP) and in compliance with local regulatory requirements. All participants or their legal guardians provided written informed consent.
All study participants applied UP256 to the face twice daily for 12 weeks. Participants were permitted to use moisturizer and sunscreen as needed. Clinical assessments were conducted at the screening, baseline, and week 4, 8, and 12 (end of treatment) study visits. Both inflammatory and non-inflammatory lesion counts were recorded as well as Evaluator Global Severity Score (EGSS) assessments of acne severity, erythema, dryness, oiliness, desquamation, and post-inflammatory
Male and female individuals between the ages of 12 and 30 years old with 6-point Investigator’s Global Assessment (IGA) scores indicating mild (IGA=2) or moderate (IGA=3) facial acne vulgaris were eligible to enroll in this study. Eligible participants were required to have 10–40 inflammatory lesions (papules, pustules, and nodules), 10–40 non-inflammatory lesions (closed and open comedones), and <2 facial cystic lesions. Main exclusion criteria included acne conglobata, acne fulminans, nodulocystic acne, and hormonal acne. A urine pregnancy test was required for female subjects at the screening and each study visit. In addition, washout periods of 14 days for topical acne medications, 30 days for oral antibiotics and investigational drugs, and 6 months for isotretinoin were also required. Prior to enrolling participants, the study protocol was approved by the Institutional Review Board at SUNY-Downstate Health Sciences University. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practices (GCP) and in compliance with local regulatory requirements. All participants or their legal guardians provided written informed consent.
All study participants applied UP256 to the face twice daily for 12 weeks. Participants were permitted to use moisturizer and sunscreen as needed. Clinical assessments were conducted at the screening, baseline, and week 4, 8, and 12 (end of treatment) study visits. Both inflammatory and non-inflammatory lesion counts were recorded as well as Evaluator Global Severity Score (EGSS) assessments of acne severity, erythema, dryness, oiliness, desquamation, and post-inflammatory
