At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 137 enrolled
Drug / intervention
5-ALA Photodynamic Therapy +1 moredrug
Likely dose
Cryotherapy with liquid nitrogen 500mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Formulation of 5-aminolevulinic Acid With Dimethylsulfoxide in Photodynamic Therapy for Treatment of Actinic Keratosis
In Brief
A Phase 3 clinical trial evaluating 5-ALA Photodynamic Therapy and Cryotherapy with liquid nitrogen for Actinic Keratosis. Completed, enrolled 137 participants across 1 site.
Detailed Summary
This study aims to compare in a prospective and randomized way actinic keratosis treatment with 5-aminolevulinic acid photodynamic therapy versus cryotherapy, from the standpoint of therapeutic efficacy, pain, and cosmetic results.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesBrazil
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedOct 2011
Primary CompletionNov 2011
TodayJul 2026
First PostedOct 25, 2011
Enrollment StartNov 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.7 years ago
Interventions
5-ALA Photodynamic Therapydrug
Cryotherapy with liquid nitrogendrug
Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.