Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)
Information source: MEDA Pharma GmbH & Co. KG
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Actinic Keratosis
Intervention: Imiquimod (Drug); Diclofenac (Drug)
Phase: Phase 4
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
B├Ąrbel 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).
Time to recurrence
Need of rescue treatment
Minimum age: 18 Years.
Maximum age: N/A.
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
- Willingness to comply with the obligations of the study.
A patient is ineligible and must not enter the study if any of the following criteria is
- History of hypersensitivity to imiquimod, diclofenac, acetyl salicylic acid, other
non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant
- 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
- 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
- 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 ┬Ág/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.
- 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).
Locations and Contacts
B├Ąrbel 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: firstname.lastname@example.org
Peter Wolf, Prof., MD, Principal Investigator
Medical Practice, Maria Enzersdorf A-2344, Austria; Recruiting
Julia Fr├╝hauf, MD, Phone: +43 2236 30 40 86-0, Email: email@example.com
Julia Fr├╝hauf, MD, Principal Investigator
Medical University Vienna, Department for General Dermatology, Vienna A-1090, Austria; Recruiting
Rainer Kunstfeld, Prof., MD, Phone: +43 316 384133, Email: firstname.lastname@example.org
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: email@example.com
Georg Popp, MD, Principal Investigator
Medical Supply Center, Augsburg D-86163, Germany; Recruiting
Ridwan Weber, MD, Phone: +49 821 661366, Email: firstname.lastname@example.org
Ridwan Weber, MD, Principal Investigator
Medical Practice, Berlin D-10437, Germany; Not yet recruiting
Karl-Gustav Meyer, MD, Phone: +49 30 4459544, Email: email@example.com
Karl-Gustav Meyer, MD, Principal Investigator
Medical Practice, Duelmen D-48249, Germany; Recruiting
Rolf Dominicus, MD, Phone: +49 2594 909713, Email: firstname.lastname@example.org
Rolf Dominicus, Principal Investigator
University Clinic for Dermatology Erlangen, Erlangen D-91052, Germany; Not yet recruiting
J├╝rgen Bauerschmitz, MD
J├╝rgen 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: email@example.com
Diamant Thaci, MD, Principal Investigator
Medical Practice, Germering D-82110, Germany; Recruiting
Claus Jung, MD, Phone: +49 89 843077, Email: firstname.lastname@example.org
Claus Jung, MD, Principal Investigator
Study Center for Dermatology at Campus L├╝beck, University Clinic Schleswig-Holstein, L├╝beck 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: email@example.com
Harald Gollnick, Prof., MD, Principal Investigator
Medical Practice, Mahlow D-15831, Germany; Recruiting
Michael Sebastian, MD, Phone: +49 03379 39423, Email: firstname.lastname@example.org
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: email@example.com
Petra Staubach-Renz, MD, PD, Principal Investigator
Medical Practice, Markkleeberg D-04416, Germany; Recruiting
Ina Schulze, MD, Phone: +49 341 3502975, Email: firstname.lastname@example.org
Ina Schulze, MD, Principal Investigator
Medical Practice for Dermatology and Medical Cosmetics, M├Ânchengladbach 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, M├╝nster D-48143, Germany; Recruiting
Stephan M├╝ller, MD, Phone: +49 251 482340, Email: email@example.com
Stephan M├╝ller, MD, Principal Investigator
Derma Center Vechta, Clinic for Dermatology, Vechta D-49377, Germany; Recruiting
Frank Borrosch, MD, Phone: +49 4441 88753 0, Email: firstname.lastname@example.org
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