Ann Dermatol.  2010 Feb;22(1):21-25. 10.5021/ad.2010.22.1.21.

The Efficacy and Safety of 4-n-butylresorcinol 0.1% Cream for the Treatment of Melasma: A Randomized Controlled Split-face Trial

• Huh SY
• Shin JW
• Na JI
• Huh CH
• Youn SW
• Park KC

• KMID: 2172032
• DOI: http://doi.org/10.5021/ad.2010.22.1.21

Abstract

BACKGROUND
Melasma is a common acquired symmetrical hypermelanosis that occurs on sun-exposed areas, and it is frequently observed among women. Various treatment modalities have been tried, but none are completely satisfactory. 4-n-butylresorcinol, which is a resorcinol derivative that has an inhibitory effect on both tyrosinase and tyrosinase-related protein-1, was introduced in 1995 and it has received increasing attention as a new hypopigmenting agent. However, the hypopigmenting effect of 4-n-butylresorcinol in human subjects has only been shown in a few studies.
OBJECTIVE
The aim of this study was to investigate the hypopigmenting efficacy and safety of 4-n-butylresorcinol 0.1% cream for the treatment of melasma.
METHODS
Twenty patients with melasma were enrolled to this randomized, double-blind, vehicle-controlled, split-face comparative study. The patients were instructed to apply 4-n-butylresorcinol 0.1% cream or vehicle to each side of the face twice daily for 8 weeks. Mexameter measurements were performed along with photography at baseline, 4 weeks and 8 weeks. Adverse events were observed and recorded throughout the study. RESULTS: All the patients completed the study. Mexameter measurements demonstrated that the melanin index of the treated side showed a significant decrease when compared with that of the vehicle-treated side after 4 weeks (p=0.006) and after 8 weeks (p<0.0005). All the adverse reactions were mild and transient.
CONCLUSION
4-n-butylresorcinol 0.1% cream showed rapid efficacy and it was well tolerated when used for the treatment of melasma.

Keyword

4-n-butylresorcinol; Melasma; Randomized controlled trial; Split-face design; Treatment

MeSH Terms

Female
Humans
Hyperpigmentation
Melanins
Melanosis
Monophenol Monooxygenase
Oxidoreductases
Photography
Resorcinols
Melanins
Monophenol Monooxygenase
Oxidoreductases
Resorcinols

Figure

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  Fig. 1 Changes in the melanin index (MI) during the 8-week study period.

• 

  Fig. 2 Patient 1: A 41-year-old woman with melasma was treated with 4-n-butylresorcinol 0.1% cream, and her melanin index (MI) decreased from 221.33 to 210.33 (-11.00). The clinical presentation at baseline with the MI: 221.33 (A), after 4 weeks with the MI: 215.33 (B) and after 8 weeks with the MI: 210.33 (C).

• 

  Fig. 3 Patient 2: A 46-year-old woman with melasma was treated with 4-n-butylresorcinol 0.1% cream, and her MI decreased from 234.00 to 208.00 (-26.00). The clinical presentation at baseline with the MI: 234.00 (A), after 4 weeks with the MI: 213.00 (B) and after 8 weeks with the MI: 208.00 (C).

• 

  Fig. 4 Patient 3: A 44-year-old woman with melasma was treated with 4-n-butylresorcinol 0.1% cream, and her MI decreased from 223.00 to 189.33 (-33.67). The clinical presentation at baseline with the MI: 223.00 (A), after 4 weeks with the MI: 197.33 (B) and after 8 weeks with the MI: 189.33 (C).

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