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 ]

Solar lentigines count at each visit, up to 13 weeks


Original Primary Outcome: Same as current

Current Secondary Outcome: Severity of Post-inflammatory hyperpigmentation [ Time Frame: up to 13 weeks ]

scale of 4 points for post-inflammatory hyperpigmentation


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