Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)

PHASE4CompletedINTERVENTIONAL
Enrollment

221

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Actinic Keratosis
Interventions
DRUG

Imiquimod

One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT.

DRUG

Diclofenac

Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks.

Trial Locations (17)

A-8036

Medical University Graz, University Clinic for Dermatology and Venerology Graz, Graz

A-2344

Medical Practice, Maria Enzersdorf

A-1090

Medical University Vienna, Department for General Dermatology, Vienna

D-86163

Medical Supply Center, Augsburg

D-86179

Licca Clinical Research Institute, Clinic for Dermatolgy and Surgery, Augsburg

D-10437

Medical Practice, Berlin

D-48249

Medical Practice, Dülmen

D-82110

Medical Practice, Germering

D-39120

Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venerology, Magdeburg

D-15831

Medical Practice, Mahlow

D-55131

Department of Dermatology Johannes Gutenberg-University Mainz, Clinical Research Center, Mainz

D-04416

Medical Practice, Markkleeberg

D-41061

Medical Practice for Dermatology and Medical Cosmetics, Mönchengladbach

D-48143

Medical Practice, Münster

D-49377

Derma Center Vechta, Clinic for Dermatology, Vechta

D-58453

Centrovital, Medical Practice for Dermatology, Witten

D-42275

Medical Practice for Dermatology and Venerology, Wuppertal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Siro Clinpharm Germany GmbH (until June 2013)

UNKNOWN

collaborator

Accovion GmbH

INDUSTRY

lead

MEDA Pharma GmbH & Co. KG

INDUSTRY