title: Triple combination as adjuvant to cryotherapy in the treatment of solar lentigines: investigator-blinded, randomized clinical trial.
abstract: BACKGROUND
  Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Brazilian Center for Studies in Dermatology, Porto Alegre, Brazil.
authors.forename: D
authors.initials: D
authors.lastname: Hexsel
authors.forename: C
authors.initials: C
authors.lastname: Hexsel
authors.forename: M D
authors.initials: MD
authors.lastname: Porto
authors.forename: C
authors.initials: C
authors.lastname: Siega
mesh_terms: D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000975:Antioxidants / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D017679:Cryotherapy / Q000009:adverse effects; D004338:Drug Combinations; D004890:Erythema / Q000209:etiology; D005260:Female; D005446:Fluocinolone Acetonide / Q000627:therapeutic use; D006229:Hand Dermatoses / Q000209:etiology / Q000628:therapy*; D006801:Humans; D006873:Hydroquinones / Q000627:therapeutic use; D007911:Lentigo / Q000209:etiology / Q000378:metabolism / Q000628:therapy*; D008297:Male; D008543:Melanins / Q000378:metabolism; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D063465:Skin Cream / Q000009:adverse effects / Q000627:therapeutic use*; D013472:Sunlight / Q000009:adverse effects; D014212:Tretinoin / Q000627:therapeutic use
chemical_list: D000893:Anti-Inflammatory Agents; D000970:Antineoplastic Agents; D000975:Antioxidants; D004338:Drug Combinations; D006873:Hydroquinones; D008543:Melanins; D005446:Fluocinolone Acetonide; D014212:Tretinoin; C031927:hydroquinone