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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00777127
First received: October 21, 2008
Last updated: January 31, 2013
Last verified: January 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Recurrence with respect to the study treatment area until month 12 [ Time Frame: week 20 until month 12 ] [ Designated as safety issue: Yes ]
    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 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 ]

Enrollment: 258
Study Start Date: December 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777127

Locations
Austria
Hospital Feldkirch, Department for Dermatology and Venereology
Feldkirch, Austria, A-6807
Medical University Graz, University Clinic for Dermatology and Venereology
Graz, Austria, A-8036
Medical University Innsbruck, University Clinic for Dermatology and Venereology
Innsbruck, Austria, A-6020
Medical University Vienna, Department for General Dermatology
Vienna, Austria, A-1090
France
CHU St Jacques, Department for Dermatology
Besancon Cedex, France, F-25030
Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor
Marseille, France, F-13009
CHU Nice - Hospital Archet 2, Department for Dermatology
Nice, France, F-06202
Hospital Saint-Louis, Derpartment for Dermatology
Paris, France, F-75010
Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology
Pierre Benite, France, F-69495
Germany
Licca Clinical Research Institute
Augsburg, Germany, D-86179
Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology
Berlin, Germany, D-10117
Medical Practice Dominicus / Bockhorst
Duelmen, Germany, D-48249
Medical practice
Düsseldorf, Germany, D-40210
University Clinic Düsseldorf, Clinic for Dermatology
Düsseldorf, Germany, D-40255
Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology
Frankfurt am Main, Germany, D-60590
SCiderm GmbH
Hamburg, Germany, D-20354
Medical Practice
Hannover, Germany, D-30159
University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology
Kiel, Germany, D-24105
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology
Magdeburg, Germany, D-39120
Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center
Mainz, Germany, D-55131
Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics
Mönchengladbach, Germany, D-41061
University Clinic Münster, Clinic and Polyclinic for Skin Diseases
Münster, Germany, D-48149
Clinic University Regensburg, Clinic and Polyclinic for Dermatology
Regensburg, Germany, D-93053
Derma Center Vechta
Vechta, Germany, D-49377
Centrovital
Witten, Germany, D-58453
Medical practice for Dermatology and Venerology
Wuppertal, Germany, D-42275
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: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00777127     History of Changes
Other Study ID Numbers: X-03016-3271, 2007-004884-24
Study First Received: October 21, 2008
Last Updated: January 31, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

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

ClinicalTrials.gov processed this record on July 26, 2014