Long-Term Effects of Imiquimod and Diclofenac in Actinic Keratoses

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):
Harald Gollnick, MD, Prof., Principal Investigator, Affiliation: Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology
Ursula Petzold, PhD, Study Director, Affiliation: MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany

Overall contact:
Jenny Cadée, PhD, Phone: +31 30 258, Ext: 46 21, Email: cadee.jenny@kendle.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 or Solaraze® 3% gel 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 (LEIDA)

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: a) Primary Endpoint: Recurrence with respect to the study treatment area. A patient is classified as recurrent when cleared at Visit Week 20 and having later on at least one clinically diagnosed AK lesion in the study treatment area.

Secondary outcome:

Time to recurrence

Long-term outcome with respect to development of SCC (in situ and/or invasive)

Need of rescue treatment

Haematological changes

Cosmetic outcome.

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

Criteria:

Inclusion 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 (see Section 7. 1.1. 2). 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:

Safety concerns:

- History of allergic reaction 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 marked hyperkeratosis or

hypertrophy 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.

- Topical treatment with imiquimod or diclofenac anywhere else on the body within the

last 2 months prior to randomisation.

- 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 where metastasis could be

expected.

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

haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.

- 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).

Jenny Cadée, PhD, Phone: +31 30 258, Ext: 46 21, Email: cadee.jenny@kendle.com

Medical University Vienna, Department for General Dermatology, Vienna A-1090, Austria; Recruiting
Rainer Kunstfeld, MD, Prof., Phone: +43 1 40400, Ext: 6262, Email: rainer.kunstfeld@meduniwien.ac.at

Medical University Innsbruck, University Clinic for Dermatology and Venereology, Innsbruck A-6020, Austria; Not yet recruiting
Peter Fritsch, MD, Prof., Phone: +43 512 504, Ext: 22990, Email: peter.fritsch@i-med.ac.at

Hospital Feldkirch, Department for Dermatology and Venereology, Feldkirch A-6807, Austria; Recruiting
Robert Strohal, MD, Phone: +43 5522 303, Ext: 7526, Email: robert.strohal@lkhf.at

Medical University Graz, University Clinic for Dermatology and Venereology, Graz A-8036, Austria; Recruiting
Peter Wolf, MD, Prof., Phone: +43 316 385, Ext: 7092, Email: peter.wolf@meduni-graz.at

CHU Nice - Hospital Archet 2, Department for Dermatology, Nice F-06202, France; Recruiting
Jean-Paul Ortonne, Prof., Phone: +33 4 92 03 64, Ext: 88, Email: jean-paul.ortonne@unice.fr

Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor, Marseille F-13009, France; Recruiting
Jean-Jacques Grob, Prof., Phone: +33 4 91 74 47, Ext: 08, Email: jean-jacques.grob@mail.ap-hm.fr

CHU St Jacques, Department for Dermatology, Besancon Cedex F-25030, France; Recruiting
Philippe Humbert, Prof., Phone: +33 3 81 21 83, Ext: 01, Email: philippe.humbert@univ-fcomte.fr

Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology, Pierre Benite F-69495, France; Recruiting
Catherine Goujon, MD, Phone: +33 4 78 86 41, Ext: 25, Email: catherine.goujon@chu-lyon.fr

Hospital Tenon, Department for Dermatology, Paris F-75020, France; Not yet recruiting
Olivier Chosidow, Prof., Phone: +33 1 56 01 76, Ext: 70, Email: olivier.chosidow@tnn.aphp.fr

Hospital Saint-Louis, Derpartment for Dermatology, Paris F-75010, France; Recruiting
Nicole Basset-Seguin, Prof., Phone: +33 1 53 72 20, Ext: 66, Email: nicole.basset-seguin@sls.aphp.fr

Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology, Magdeburg D-39120, Germany; Recruiting
Harald Gollnick, MD, Prof., Phone: +49-391-671, Ext: 5249, Email: harald.gollnick@medizin.uni-magdeburg.de

Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology, Berlin D-10117, Germany; Recruiting
Eggert Stockfleth, MD, Prof., Phone: +49 30 450 518, Ext: 266, Email: eggert.stockfleth@charite.de

SCiderm GmbH, Hamburg D-20354, Germany; Recruiting
Volker Steinkraus, MD, Prof., Phone: +49 40 554401, Email: info@dermatologikum.de

University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology, Kiel D-24105, Germany; Not yet recruiting
Axel Hauschild, MD, Prof., Phone: +49 431 597, Ext: 1853, Email: ahauschild@dermatology.uni-kiel.de

Medical practice, Düsseldorf D-40210, Germany; Not yet recruiting
Ullrich Hengge, MD, Prof., Phone: +49 211 811, Ext: 8066, Email: ullrich.hengge@uni-duesseldorf.de

Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics, Mönchengladbach D-41061, Germany; Recruiting
Rolf Ostendorf, MD, Phone: +49 2161, Ext: 182475, Email: ostendorf-rolf@t-online.de

University Clinic Münster, Clinic and Polyclinic for Skin Diseases, Münster D-48149, Germany; Recruiting
Thomas Luger, MD, Prof., Phone: N.N., Email: derma@uni-muenster.de

Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center, Mainz D-55131, Germany; Recruiting
Petra Staubach, MD, Phone: +49 6131 17, Ext: 5244, Email: stephan.grabbe@ukmainz.de

Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology, Frankfurt am Main D-60590, Germany; Recruiting
Diamant Thaci, MD, Phone: +49 69 6301, Ext: 6556, Email: Thaci@em.uni-frankfurt.de

Clinic University Regensburg, Clinic and Polyclinic for Dermatology, Regensburg D-93053, Germany; Recruiting
Rolf Szeimies, MD, Prof., Phone: +49 941 944, Ext: 9614, Email: rolf-markus.szeimies@klinik.uni-regensburg.de

University Clinic Düsseldorf, Clinic for Dermatology, Düsseldorf D-40255, Germany; Recruiting
Karl-Werner Schulte, MD, Prof., Phone: +49 211811, Ext: 8066

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

Starting date: December 2008
Ending date: April 2012
Last updated: April 7, 2009