Efficacy and safety of 2% kojic acid containing formulation versus modified Kligman’s formula in melasma - a comparative study
Keywords:
Melasma, kojic acid, modified Kligman’s formulaAbstract
Objective To compare therapeutic efficacy of modified Kligman’s formula containing 2% hydroquinone, 0.025% tretinoin, 0.01% fluocinolone acetonide (group A), and 2% kojic acid + octinoxate + allantoin (group B) in treatment of melasma.Methods 30 patients each, men and nonpregnant women > 18 years and < 45 years of age with epidermal melasma, were included in each group for the clinical study. Group A was given modified Kligman’s formula (MKF) containing 2% hydroquinone, 0.025% tretinoin, 0.01% fluocinolone acetonide cream and group B was prescribed 2% kojic acid + octinoxate + allantoin containing gel daily at night. Patients were followed-up monthly for 3 months.Results Patients in group A had a mean baseline MASI (MASI0) score 7.93±4.62 compared to patients in group B, who had mean baseline (MASI0) MASI score 10.02.±5.81. After completion of treatment i.e. after 3 follow-ups (MASI3), the mean MASI score was 5.85 ±3.96 in group A compared to 3.35±4.25 in group B. The mean reduction in MASI score was 2.08 (26.22%), 6.67 (66.5%) at the end of treatment in group A and group B, respectively. In both the groups the reduction in MASI was statistically highly significant. In group A, there was a significant decrease in MASI score at the end of 3 months (P < 0.001) but, there was no significant change at the end of one month (P = 0.759). In group B, there was a significant decrease in MASI at the end of 3 months (P ≤ 0.0001). However unlike group A, there was a significant decrease in MASI one month and 2 months (P < 0.0001). In comparison between the two groups, at the end of first month, second month and third month, group A showed better effect (P <0.0001 HS) compared to group B. So, at the end of study period, group A showed statistically better efficacy than group B.Conclusion For initial induction of remission in melasma, modified Kligman’s formula is recommended and subsequent long-term maintenance can be achieved with 2% kojic acid containing formulations. Long-term follow-up of the patients could not be done in our study to see for relapse after stopping treatment.References
Sori T, Nath AK, Thappa DM, Jaisankar TJ. Hypopigmentary disorders in children in South India. Indian J Dermatol. 2011; 56: 546-9.
Pawaskar MD, Parikh P, Markowski T, McMichael AJ, Feldman SR, Balkrishnan R. Melasma and its impact on health-related quality of life in Hispanic women. J Dermatolog Treat. 2007; 18: 5-9.
Anderson RT, Rajagopalan R. Development and validation of a quality of life instrument for cutaneous diseases. J Am Acad Dermatol. 1997; 37: 41-50
Deo KS, Dash KN, Sharma YK, Virmani NC, Oberai C. KA vis-a-vis its combinations with HQ and betamethasone valerate in melasma: a randomized, single blind, comparative study of efficacy and safety. Indian J Dermatol. 2013; 58: 281-5.
B.C. Dwari, S. Palaian, A. Poudel, S. Prabhu: Clinical profile and management pattern of melasma patients in Western Nepal: A Hospital Based Study. Internet J Dermatol. 2009; 7.
Sanchez NP, Pathak MA, Sato S, Fitzpatrick TB, Sanchez JL, Mihm MC Jr. Melasma: A clinical, light microscopic, ultrastructural and immunofluorescence study. J Am Acad Dermatol. 1981; 4: 698-710.
Aswanonda P, Tyalo CR. Woods light in dermatology. Int J Dermatol. 1999; 38: 801-7.
Kimbrough-Green CK, Griffiths CE, Finkel LJ, Hamilton TA, Bulengo-Ransby SM, Ellis CN et al. Topical retinoic acid (tretinoin) for melasma in black patients. Arch Dermatol. 1994; 130: 727-33.
Grimes P, Kelly AP, Torok H, Willis I. Community-based trial of a triple combination agent for the treatment of facial melasma. Cutis. 2006; 77: 177-84.
Monteiro RC, Kishore BN, Bhat RM, Sukumar D, Martis J, Ganesh HK. A comparative study of the efficacy of 4% HQ vs 0.75% KA cream in the treatment of facial melasma. Indian J Dermatol. 2013; 58: 157.
Taylor SC, Torok H, Jones T, Lowe N, Rich P, Tschen E et al. Efficacy and safety of a new triple-combination agent for the treatment of facial melasma. Cutis. 2003; 72: 67-72.
