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

NCT02281682 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2017-10-30

No results posted yet for this study

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.

Conditions

  • Keratosis, Actinic

Interventions

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Klara Mosterd, MD, PhD · Maastricht University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-07-31
Completion
2018-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281682 on ClinicalTrials.gov