NCT02281682

IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis

Topical Ingenol Mebutate Versus 5% 5-fluorouracil Versus 5% Imiquimod Versus Photodynamic Therapy in Treatment of Actinic Keratosis: a Multi-centre Randomized Efficacy and Cost-effectiveness Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 624 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-centre randomised controled single blind clinical phase IV trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel.

Detailed description

Skin cancer is the most common cancer in Caucasians and therefore a major public health issue. Its incidence is increasing rapidly. Actinic keratosis (AK) is the most prevalent precancerous chronic skin condition. It can transform into squamous cell carcinoma (SCC). AK's generally arise in a skin area that has diffuse precancerous damage, a phenomenon called field cancerization. Because of its precancerous character, it is advised to treat AK and herewith prevent development into SCC. The most frequently used field-directed treatments in the Netherlands are photodynamic therapy (PDT), topical 5% f-fluorouracil (5% 5-FU) and topical 5% Imiquimod (5% IMI). Lately another topical product is approved by Dutch healthcare insurances: Ingenol mebutate (IM). Up to date, which treatment the patient will receive, does not rely on evidence-based-medicine, but generally on the preference of the physician. Current national and international guidelines state no clear recommendations for the best choice of therapy. The aim of this study determine which treatment is the most effective treatment in terms of lesion reduction, costs and patient satisfaction when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel, in treatment of actinic keratosis (AK).

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DRUG	Imiquimod	three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
DRUG	5-fluorouracil	during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
DRUG	Ingenol mebutate	during 3 (consecutive) days once daily. Prior to treatment: curettage
PROCEDURE	methylaminolevulinate photodynamic therapy	methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-07-01
• Completion: 2018-12-01
• First posted: 2014-11-03
• Last updated: 2017-10-30

Locations

1 site across 1 country: Netherlands