Efficacy and safety of liposome-encapsulated 4-n-butylresorcinol 0.1% cream for the treatment of melasma: a randomized controlled split-face trial.
Melasma is an acquired pigmentary disorder that most commonly occurs in women of child-bearing age. Melasma is therapeutically challenging, and most commercially available hypopigmenting agents include tyrosinase inhibitors, which regulate the rate-limiting step of melanogenesis. 4-n-Butylresorcinol has received considerable attention as a novel hypopigmenting agent in the last 15 years because it has an inhibitory effect against tyrosinase and tyrosinase-related protein-1. However, the hypopigmenting effect of 4-n-butylresorcinol in human subjects has only been shown in a few studies. Liposome encapsulation is known to improve stabilization and enhance penetration of the product. Therefore, this study was conducted to evaluate the hypopigmenting efficacy and safety of liposome-encapsulated 4-n-butylresorcinol 0.1% cream in patients with melasma. This was a randomized, double-blind, vehicle-controlled and split-face comparison study. Twenty-three patients with a clinical diagnosis of melasma were included. 4-n-Butylresorcinol 0.1% cream or vehicle was applied to each side of the face twice daily for 8 weeks. Clinical and photographic evaluations, Mexameter measurements and assessment of patient satisfaction and side-effects were performed at baseline, 4 and 8 weeks. All subjects completed the study. Mexameter measurements demonstrated that the melanin index of the 4-n-butylresorcinol-treated side showed a significant decrease when compared with the vehicle-treated side after 8 weeks (P = 0.043). No adverse reactions were observed throughout the study. Subjectively, 4-n-butylresorcinol was considered to be efficacious in more than 60% of the patients after 8 weeks of treatment. In conclusion, liposome-encapsulated 4-n-butylresorcinol 0.1% cream was well tolerated and showed significant higher efficacy than vehicle alone for the treatment of melasma.
Huh
Sun Young
SY
Department of Dermatology, Seoul National University College of Medicine, Seoul, Korea.
Shin
Jung-Won
JW
Na
Jung-Im
JI
Huh
Chang-Hun
CH
Youn
Sang-Woong
SW
Park
Kyoung-Chan
KC
D000328:Adult; D044466:Asian People; D002214:Capsules; D004304:Dosage Forms; D005260:Female; D006801:Humans; D007723:Korea; D008081:Liposomes; D008548:Melanosis / Q000188:drug therapy*; D008875:Middle Aged; D014442:Monophenol Monooxygenase / Q000032:analysis; D010088:Oxidoreductases / Q000032:analysis; D017060:Patient Satisfaction; D012118:Resorcinols / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
C508220:4-n-butylresorcinol; D002214:Capsules; D004304:Dosage Forms; D008081:Liposomes; D012118:Resorcinols; D010088:Oxidoreductases; C064056:tyrosinase-related protein-1; D014442:Monophenol Monooxygenase