Clinical Trial: A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety and Efficacy of a Triple Combination Cream as Adjuvant Treatment of Solar Lentigines With Cryotherapy.
Brief Summary: To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
Detailed Summary:
To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.
The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.
Sponsor: Brazilan Center for Studies in Dermatology
Current Primary Outcome: Solar lentigines count at each visit [ Time Frame: up to 13 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Severity of Post-inflammatory hyperpigmentation [ Time Frame: up to 13 weeks ]
Original Secondary Outcome: Same as current
Information By: Brazilan Center for Studies in Dermatology
Dates:
Date Received: January 4, 2013
Date Started: April 2011
Date Completion:
Last Updated: July 19, 2016
Last Verified: July 2016