title: Assessment of efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream: an Indian multicentric study on melasma.
abstract: BACKGROUND
  Melasma is one of the commonly reported pigmentory disorders in the Indian population. Numerous therapeutic modalities are available. However, very few have produced complete satisfactory response. 4-n-Butylresorcinol 0.3% cream has recently been introduced in India as a new hypopigmenting agent. It is a resorcinol derivative and acts by inhibiting both tyrosinase and tyrosinase-related protein-1.
  
  
  OBJECTIVE
  The available published literatures are with 4-n-butylresorcinol 0.1% cream, and there is paucity of clinical studies with 4-n-butylresorcinol 0.3% cream. Furthermore, considering the fact that Indian skin is more prone to irritation with hypopigmenting agents, our study explores the efficacy, safety, and tolerability of 4-n-butylresorcinol 0.3% cream in Indian subjects with melasma.
  
  
  METHODS
  Fifty-two subjects with melasma participated in this open-label, single arm, observational study. All the patients were advised twice daily application of 4-n-butylresorcinol 0.3% cream for 8 weeks over the areas of melasma. Assessment parameters included modified Melasma Area Severity Index (mMASI) score. Digital photographs of all the patients at baseline, week 4, and week 8 were taken. During this 8-week study period, all the adverse events were observed and recorded.
  
  
  RESULTS
  All the 52 subjects completed the study. Out of 52 subjects, 90.38% were females. The mean age of patients was 38.5±7.8 years. Mean ± standard error of MASI score measurements showed a significant decrease from baseline score of 14.73±0.59 to 11.09±0.53 after week 4 (P<0.001) and 6.48±0.43 at week 8 (P<0.001). The digital photographs of the study subjects taken at week 4 and week 8 also showed decrease in melasma pigmentation compared to baseline photograph and correlated with the changes in the mMASI score. The treatment was well tolerated by all the study subjects. No adverse reactions were reported throughout the study period.
  
  
  CONCLUSIONS
  Our data suggest that the 4-n-butylresorcinol 0.3% cream is safe, effective, and well tolerated in Indian patients with melasma.
authors: Department of Dermatology, Dr BR Ambedkar Medical College (BRAMC), Bangalore, Karnataka, India.
authors: N T
authors: NT
authors: Madan Mohan
authors: Department of Dermatology, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, Karnataka, India.
authors: Adarsh
authors: A
authors: Gowda
authors: Department of Dermatology, Dr BR Ambedkar Medical College (BRAMC), Bangalore, Karnataka, India.
authors: Ashok Kumar
authors: AK
authors: Jaiswal
authors: Department of Dermatology, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, Karnataka, India.
authors: B C
authors: BC
authors: Sharath Kumar
authors: Department of Dermatology, Dr BR Ambedkar Medical College (BRAMC), Bangalore, Karnataka, India.
authors: P
authors: P
authors: Shilpashree
authors: Department of Community Medicine, Kempegowda Institute of Medical Sciences (KIMS), Bangalore, Karnataka, India.
authors: Bilugumba
authors: B
authors: Gangaboraiah
authors: Medical Services, Micro Labs Ltd, Bangalore, Karnataka, India.
authors: Manjula
authors: M
authors: Shamanna
keywords: 4-n-butylresorcinol; melasma; topical treatment; tyrosinase inhibitors