CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Ingenol Mebutate +1 moredrug
Likely dose
Not stated in 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.

Search/NCT02251652
NCT02251652Phase 4Completed
CompareCT.gov

An Investigator-Initiated Study to Assess the Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses (AK) on Dorsal Hands

Icahn School of Medicine at Mount Sinai·interventional·Posted Sep 29, 2014·Updated Apr 26, 2017

In Brief

A Phase 4 clinical trial evaluating Ingenol Mebutate and Cryotherapy for Actinic Keratoses. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore, use of ingenol mebutate will also be evaluated for potential treatment of subclinical lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratoses
CountriesUnited States
CollaboratorsLEO Pharma

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2014
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2014
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.8 years ago

Interventions

Ingenol Mebutatedrug

Ingenol mebutate 0.05% gel

Cryotherapyprocedure

1-2 sprays, 5 seconds each, with a 5 second interval