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

Condition(s) targeted: Actinic Keratosis

Intervention: Imiquimod (Drug); Diclofenac (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: MEDA Pharma GmbH & Co. KG

Official(s) and/or principal investigator(s):
Ursula Petzold, Dr., Study Director, Affiliation: MEDA Pharma GmbH & Co. KG
Harald Gollnick, Prof. Dr., Principal Investigator, Affiliation: Otto-von-Guericke-University of Magdeburg

Overall contact:
Bärbel Fingerhut, Phone: +49 69 8509 338, Ext: 49, Email: Baerbel.Fingerhut@siroclinpharm.com

This clinical trial serves the purpose to compare the long-term effects of a treatment of

actinic keratosis - your skin disorder - using Aldara® 5% cream (Imiquimod) or Solaraze® 3%

gel (Diclofenac) on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i. e. the damaged skin parts) can be maintained for a prolonged period.

Official title: Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp With Respect to the Risk of Progression to In-situ and Invasive Squamous Cell Carcinoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Long-term outcome with respect to the risk of progression to SCC (in situ and/or invasive) of treatment with Aldara® 5% cream (IMIQ) and Solaraze® 3% gel (DIC) with increased precision (meta-analysis with study 3271).

Secondary outcome:

Recurrence rate

Time to recurrence

Need of rescue treatment

Cosmetic outcome

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

To be eligible, a patient must comply with all of the following criteria:

- Immunocompetent patient.

- A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical

visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.

- A positive histological finding for AK grade I or II. This will be determined from

the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.

- Willingness to comply with the obligations of the study.

Exclusion Criteria:

A patient is ineligible and must not enter the study if any of the following criteria is met:

Safety concerns:

- History of hypersensitivity to imiquimod, diclofenac, acetyl salicylic acid, other

non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.

- Pregnancy, breast-feeding or planned pregnancy during the study. Women of child

bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i. e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.

Lack of suitability for the study:

- Presence of AK lesions in the STA with clinically excessive hyperkeratosis as seen in

cutaneous horns.

- Any topical AK treatment including imiquimod or diclofenac, or any systemic AK

treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.

- Persisting AK lesion at screening visit following topical treatment with imiquimod or

diclofenac in the STA.

- Presence of any histologically confirmed skin tumour in the STA: in situ SCC

including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.

- Any dermatological disease or condition that may exacerbate by treatment with

imiquimod or diclofenac (e. g. rosacea, psoriasis, atopic dermatitis).

- Any dermatological disease or condition in the STA that causes difficulty with

examination (e. g. eczema).

- Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine,

retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.

- History of any malignant tumour with high tumour burden or any systemic antitumour

treatment (incl. radiotherapy).

- History of any malignant skin tumour having metastasised or in which metastasis

within the study period is likely.

- History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal,

haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years which might hinder regular treatment and supervision and might lead to premature withdrawal from the study.

- Mentally incapacitated patient.

- Present or history of drug or alcohol abuse within the last 3 years.

Administrative reasons:

- Exposure to an investigational product within the last 3 months.

- Lack of ability or willingness to give informed consent.

- Age below 18 years.

- Lack of willingness to have personal study related data collected, archived or

transmitted according to protocol.

- Anticipated non-availability for study visits/procedures.

- Vulnerable subjects (such as persons kept in detention).

Bärbel Fingerhut, Phone: +49 69 8509 338, Ext: 49, Email: Baerbel.Fingerhut@siroclinpharm.com

Medical University Graz, University Clinic for Dermatology and Venerology Graz, Graz A-8036, Austria; Recruiting
Peter Wolf, Prof., MD, Phone: +43 316 385 13026, Email: peter.wolf@medunigraz.at
Peter Wolf, Prof., MD, Principal Investigator

Medical Practice, Maria Enzersdorf A-2344, Austria; Recruiting
Julia Frühauf, MD, Phone: +43 2236 30 40 86-0, Email: ordination@jf-hautarztpraxis.at
Julia Frühauf, MD, Principal Investigator

Medical University Vienna, Department for General Dermatology, Vienna A-1090, Austria; Recruiting
Rainer Kunstfeld, Prof., MD, Phone: +43 316 384133, Email: rainer.kunstfeld@meduniwien.ac.at
Rainer Kunstfeld, Prof., MD, Principal Investigator

Licca Clinical Research Institute, Clinic for Dermatolgy and Surgery, Augsburg D-86179, Germany; Recruiting
Georg Popp, MD, Phone: +49 821 8155122, Email: popp@licca.de
Georg Popp, MD, Principal Investigator

Medical Supply Center, Augsburg D-86163, Germany; Recruiting
Ridwan Weber, MD, Phone: +49 821 661366, Email: weberridwan@yahoo.com
Ridwan Weber, MD, Principal Investigator

Medical Practice, Berlin D-10437, Germany; Not yet recruiting
Karl-Gustav Meyer, MD, Phone: +49 30 4459544, Email: dr.k.meyer@t-online.de
Karl-Gustav Meyer, MD, Principal Investigator

Medical Practice, Duelmen D-48249, Germany; Recruiting
Rolf Dominicus, MD, Phone: +49 2594 909713, Email: praxis@hautzentrum-duelmen.de
Rolf Dominicus, Principal Investigator

University Clinic for Dermatology Erlangen, Erlangen D-91052, Germany; Not yet recruiting
Jürgen Bauerschmitz, MD
Jürgen Bauerschmitz, MD, Principal Investigator

Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venerology Frankfurt am Main, Frankfurt am Main D-60590, Germany; Recruiting
Diamant Thaci, MD, Phone: +49 69 6301 7375, Email: thaci@em.uni-frankfurt.de
Diamant Thaci, MD, Principal Investigator

Medical Practice, Germering D-82110, Germany; Recruiting
Claus Jung, MD, Phone: +49 89 843077, Email: info@hautarzt-jung.de
Claus Jung, MD, Principal Investigator

Study Center for Dermatology at Campus Lübeck, University Clinic Schleswig-Holstein, Lübeck D-23528, Germany; Not yet recruiting
Yvonne Frambach, MD
Yvonne Frambach, MD, Principal Investigator

Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venerology, Magdeburg D-39120, Germany; Recruiting
Harald Gollnick, Prof., MD, Phone: +49 391 67 15249, Email: harald.gollnick@medizin.uni-magdeburg.de
Harald Gollnick, Prof., MD, Principal Investigator

Medical Practice, Mahlow D-15831, Germany; Recruiting
Michael Sebastian, MD, Phone: +49 03379 39423, Email: info@hautarztpraxis-mahlow.de
Michael Sebastian, MD, Principal Investigator

Department of Dermatology Johannes Gutenberg-University Mainz, Clinical Research Center, Mainz D-55131, Germany; Recruiting
Petra Staubach-Renz, MD, PD, Phone: +49 6131 17 5244, Email: petra.staubach@unimedizin-mainz.de
Petra Staubach-Renz, MD, PD, Principal Investigator

Medical Practice, Markkleeberg D-04416, Germany; Recruiting
Ina Schulze, MD, Phone: +49 341 3502975, Email: ina.schulze@hautarztpraxis-markkleeberg.de
Ina Schulze, MD, Principal Investigator

Medical Practice for Dermatology and Medical Cosmetics, Mönchengladbach D-41061, Germany; Recruiting
Rolf Ostendorf, MD, Phone: +49 69 8509 338 49, Ext: For additional, Email: Baerbel.Fingerhut@siroclinpharm.com
Rolf Ostendorf, MD, Principal Investigator

Medical Practice, Münster D-48143, Germany; Recruiting
Stephan Müller, MD, Phone: +49 251 482340, Email: hautarzt@muenster.de
Stephan Müller, MD, Principal Investigator

Derma Center Vechta, Clinic for Dermatology, Vechta D-49377, Germany; Recruiting
Frank Borrosch, MD, Phone: +49 4441 88753 0, Email: fborrosch@hautarztzentrum.de
Frank Borrosch, MD, Principal Investigator

Centrovital, Medical Practice for Dermatology, Witten D-58453, Germany; Recruiting
Matthias Hoffmann, MD, Phone: +49 69 8509 338 49, Ext: For additional, Email: Baerbel.Fingerhut@siroclinpharm.com
Matthias Hoffmann, MD, Principal Investigator

Medical Practice for Dermatology and Venerology, Wuppertal D-42275, Germany; Recruiting
Thomas Dirschka, Prof., MD, Phone: +49 202 555656, Email: DrDirschka@aol.com
Thomas Dirschka, Prof., MD, Principal Investigator

European Dermatology Forum, Guidelines for the management of actinic keratoses. Last modified 26 Ocotober 2006.

Starting date: October 2011
Last updated: December 2, 2011