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Long-Term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA)
This study is currently recruiting participants.
Verified by MEDA Pharma GmbH & Co. KG, April 2009
First Received: October 21, 2008   Last Updated: April 7, 2009   History of Changes
Sponsored by: MEDA Pharma GmbH & Co. KG
Information provided by: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00777127
  Purpose

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.


Condition Intervention Phase
Actinic Keratosis
Drug: Imiquimod
Drug: Diclofenac
Phase IV

MedlinePlus related topics: Skin Conditions
Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac S 26308
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • 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. [ Time Frame: Week 20 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to recurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Long-term outcome with respect to development of SCC (in situ and/or invasive) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Need of rescue treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Haematological changes [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Cosmetic outcome. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: December 2008
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Aldara 5% Cream
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.
2: Active Comparator
Solaraze 3% Gel
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00777127

Contacts
Contact: Jenny Cadée, PhD +31 30 258 ext 46 21 cadee.jenny@kendle.com
Contact: Silke Kern +49 6172-888 ext 2300 silke.kern@medapharma.de

Locations
Austria
Medical University Vienna, Department for General Dermatology Recruiting
Vienna, Austria, A-1090
Contact: Rainer Kunstfeld, MD, Prof.     +43 1 40400 ext 6262     rainer.kunstfeld@meduniwien.ac.at    
Medical University Innsbruck, University Clinic for Dermatology and Venereology Not yet recruiting
Innsbruck, Austria, A-6020
Contact: Peter Fritsch, MD, Prof.     +43 512 504 ext 22990     peter.fritsch@i-med.ac.at    
Hospital Feldkirch, Department for Dermatology and Venereology Recruiting
Feldkirch, Austria, A-6807
Contact: Robert Strohal, MD     +43 5522 303 ext 7526     robert.strohal@lkhf.at    
Medical University Graz, University Clinic for Dermatology and Venereology Recruiting
Graz, Austria, A-8036
Contact: Peter Wolf, MD, Prof.     +43 316 385 ext 7092     peter.wolf@meduni-graz.at    
France
CHU Nice - Hospital Archet 2, Department for Dermatology Recruiting
Nice, France, F-06202
Contact: Jean-Paul Ortonne, Prof.     +33 4 92 03 64 ext 88     jean-paul.ortonne@unice.fr    
Hospital Saint-Louis, Derpartment for Dermatology Recruiting
Paris, France, F-75010
Contact: Nicole Basset-Seguin, Prof.     +33 1 53 72 20 ext 66     nicole.basset-seguin@sls.aphp.fr    
CHU St Jacques, Department for Dermatology Recruiting
Besancon Cedex, France, F-25030
Contact: Philippe Humbert, Prof.     +33 3 81 21 83 ext 01     philippe.humbert@univ-fcomte.fr    
Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology Recruiting
Pierre Benite, France, F-69495
Contact: Catherine Goujon, MD     +33 4 78 86 41 ext 25     catherine.goujon@chu-lyon.fr    
Hospital Tenon, Department for Dermatology Not yet recruiting
Paris, France, F-75020
Contact: Olivier Chosidow, Prof.     +33 1 56 01 76 ext 70     olivier.chosidow@tnn.aphp.fr    
Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor Recruiting
Marseille, France, F-13009
Contact: Jean-Jacques Grob, Prof.     +33 4 91 74 47 ext 08     jean-jacques.grob@mail.ap-hm.fr    
Germany
University Clinic Düsseldorf, Clinic for Dermatology Recruiting
Düsseldorf, Germany, D-40255
Contact: Karl-Werner Schulte, MD, Prof.     +49 211811 ext 8066        
Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology Recruiting
Berlin, Germany, D-10117
Contact: Eggert Stockfleth, MD, Prof.     +49 30 450 518 ext 266     eggert.stockfleth@charite.de    
SCiderm GmbH Recruiting
Hamburg, Germany, D-20354
Contact: Volker Steinkraus, MD, Prof.     +49 40 554401 ext 0     info@dermatologikum.de    
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology Not yet recruiting
Kiel, Germany, D-24105
Contact: Axel Hauschild, MD, Prof.     +49 431 597 ext 1853     ahauschild@dermatology.uni-kiel.de    
Medical practice Not yet recruiting
Düsseldorf, Germany, D-40210
Contact: Ullrich Hengge, MD, Prof.     +49 211 811 ext 8066     ullrich.hengge@uni-duesseldorf.de    
Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics Recruiting
Mönchengladbach, Germany, D-41061
Contact: Rolf Ostendorf, MD     +49 2161 ext 182475     ostendorf-rolf@t-online.de    
University Clinic Münster, Clinic and Polyclinic for Skin Diseases Recruiting
Münster, Germany, D-48149
Contact: Thomas Luger, MD, Prof.     N.N.     derma@uni-muenster.de    
Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center Recruiting
Mainz, Germany, D-55131
Contact: Petra Staubach, MD     +49 6131 17 ext 5244     stephan.grabbe@ukmainz.de    
Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology Recruiting
Frankfurt am Main, Germany, D-60590
Contact: Diamant Thaci, MD     +49 69 6301 ext 6556     Thaci@em.uni-frankfurt.de    
Clinic University Regensburg, Clinic and Polyclinic for Dermatology Recruiting
Regensburg, Germany, D-93053
Contact: Rolf Szeimies, MD, Prof.     +49 941 944 ext 9614     rolf-markus.szeimies@klinik.uni-regensburg.de    
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology Recruiting
Magdeburg, Germany, D-39120
Contact: Harald Gollnick, MD, Prof.     +49-391-671 ext 5249     harald.gollnick@medizin.uni-magdeburg.de    
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Investigators
Principal Investigator: Harald Gollnick, MD, Prof. Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology
Study Director: Ursula Petzold, PhD MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany
  More Information

Additional Information:
No publications provided

Responsible Party: n.a. ( Dr. Joachim Maus / Director, Clinical Development )
Study ID Numbers: X-03016-3271, EudraCT:2007-004884-24
Study First Received: October 21, 2008
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00777127     History of Changes
Health Authority: Austria: Federal Office for Safety in Health Care;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by MEDA Pharma GmbH & Co. KG:
actinic keratosis
invasive SCC
in situ SCC
histological classification
histological progression
clinical clearance
cryotherapy

Study placed in the following topic categories:
Anti-Inflammatory Agents
Keratosis
Immunologic Factors
Facies
Skin Diseases
Interferons
Cyclooxygenase Inhibitors
Adjuvants, Immunologic
Disease Progression
Diclofenac
Imiquimod
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Tylosis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Interferon Inducers
Keratosis
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Adjuvants, Immunologic
Diclofenac
Enzyme Inhibitors
Imiquimod
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009