Maintenance regimens with triple combination cream (0.01% fluocinolone acetonide + 4% hydroquinone + 0.05% tretinoin) in moderate to severe melasma
Tania F Cestari MD, PhD; Ma Ivonne Arellano-Mendoza, MD; Nabil Kerrouche, MSc; Marie Jose Rueda, MD
Background and Objectives: The relapsing nature of the disease is a problem for melasma treatment: there is a real need to address how to maintain efficacy achieved after acute treatment. Previous long-term data on a triple combination (TC) cream showed that 50% of the patients needed a second treatment course within 58 days after their melasma had satisfactorily resolved. As there is no robust guidance for a maintenance dosage regimen with TC, we compared two maintenance regimens with TC in patients with moderate to severe melasma.
Materials and Methods: Patients aged 18 years or older, with moderate to severe melasma [Global Severity Score (GSS) of 2 or 3], entered an initial phase where they applied TC once daily for 8 weeks. At 8 weeks, patients showing a GSS ≤ 1 (mild severity) entered an Investigator-blinded maintenance phase in which they were randomized to either TC twice weekly for 6 months (twice weekly regimen) or TC 3/week (1 month), 2/week (1 month), 1/week (4 months) (tapering regimen). A SPF 60 sunscreen was also provided. If relapse occurred (GSS≥2), patients were withdrawn from the study. The primary efficacy measure was the time to first relapse. A dichotomized variable (no relapse=0 and relapse=1) was also analyzed based on GSS.
Results and Conclusion: 320 patients were enrolled in the initial phase (52.2% moderate melasma, 47.8% severe melasma). Mean age was 41.5 years. 78.8% had no or mild melasma at the end of this phase. 242 patients entered the maintenance phase. After 4 weeks, 78% of the patients in the twice weekly group and 83.5% in the tapering regimen group remained free of relapse. This 5% difference between the two groups persisted at week 8. Starting at week 12, the two maintenance regimens display the same percentage of patients free of relapse until the end of the study. After 6 months, 53.8% patients (twice weekly) and 53% patients (tapering regimen) were free of relapse. The median time to relapse was around 190 days, regardless of the treatment regimen. Results of this study show that for physicians who do not want to treat their melasma patients daily for several months with TC, alternative maintenance regimens are possible and effective for long-term maintenance treatment of moderate to severe melasma. Such maintenance regimens could help to postpone the relapse of melasma.