Triple combination as adjuvant to cryotherapy in the treatment of solar lentigines: investigator-blinded, randomized clinical trial

Authors


  • Conflict of Interest

    • Dr. D. Hexsel has conducted clinical trials for Ipsen, Allergan, Galderma and Medicis and has worked as a consultant for Galderma. Dr. C. Hexsel has worked as a consultant for Galderma International; however, the consultancy was not about the study product reported in the present article. The other authors have no conflict of interest to disclose.
  • Funding sources

    • This study was supported by the Brazilian Center for Studies in Dermatology, a nonprofit organization. However, the triple combination cream was donated by Galderma Brazil and the neomycin cream was donated by Nycomed (Brazil).

Abstract

Background

Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines.

Objectives

To assess the safety and efficacy of a triple combination cream with fluocinolone acetonide 0.01%, hydroquinone 4% and tretinoin 0.05% as adjuvant to cryotherapy in the treatment of solar lentigines in hands dorsum, and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

Methods

This prospective, randomized, controlled, investigator-blinded, single-centre study enrolled 50 patients. Twenty-five patients received a 2-week daily triple combination cream plus sunscreen pre-treatment and 25 received sunscreen alone. After that, cryotherapy was performed in all patients followed by a 3-week recovery period. After this period, patients received the same initial treatment and were followed up for 8 weeks. Melanin and erythema levels of a target and a control lentigo were objectively measured using a narrowband reflectance spectrophotometer. Lentigines count, colour homogeneity and global improvement were also assessed.

Results

The number of solar lentigines reduced in the first 2 weeks only in patients who used the triple combination 25 ± 7 vs. 22 ± 8 (P < 0.0001), and reduced at the end of the study for both groups (P < 0.0001). The melanin levels also reduced in the first 2 weeks only in patients who used the triple combination 297 ± 69 vs. 273 ± 66 (P < 0.0001) and reduced at the end of the study for both groups (P < 0.0001). Erythema and residual blisters from cryotherapy were the reported adverse reactions.

Conclusion

Triple combination cream can be used to enhance the resolution of solar lentigines, and to significantly reduce melanin levels and lentigines count, improving treatment results. It was well-tolerated and did not increase the occurrence of neither erythema nor other side-effects after the cryotherapy.

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