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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Siro Clinpharm Germany GmbH (until June 2013)
Accovion GmbH (from June 2013)
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01453179
First received: September 30, 2011
Last updated: July 2, 2013
Last verified: July 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 (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.


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 With Respect to the Risk of Progression to In-situ and Invasive Squamous Cell Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Time to recurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Need of rescue treatment [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
  • Cosmetic outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Cosmetic outcome assessed by patient and investigator on a verbal rating scale.


Estimated Enrollment: 220
Study Start Date: October 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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:

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).
  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: NCT01453179

Locations
Austria
Medical University Graz, University Clinic for Dermatology and Venerology Graz
Graz, Austria, A-8036
Medical Practice
Maria Enzersdorf, Austria, A-2344
Medical University Vienna, Department for General Dermatology
Vienna, Austria, A-1090
Germany
Licca Clinical Research Institute, Clinic for Dermatolgy and Surgery
Augsburg, Germany, D-86179
Medical Supply Center
Augsburg, Germany, D-86163
Medical Practice
Berlin, Germany, D-10437
Medical Practice
Duelmen, Germany, D-48249
Medical Practice
Germering, Germany, D-82110
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venerology
Magdeburg, Germany, D-39120
Medical Practice
Mahlow, Germany, D-15831
Department of Dermatology Johannes Gutenberg-University Mainz, Clinical Research Center
Mainz, Germany, D-55131
Medical Practice
Markkleeberg, Germany, D-04416
Medical Practice for Dermatology and Medical Cosmetics
Mönchengladbach, Germany, D-41061
Medical Practice
Münster, Germany, D-48143
Derma Center Vechta, Clinic for Dermatology
Vechta, Germany, D-49377
Centrovital, Medical Practice for Dermatology
Witten, Germany, D-58453
Medical Practice for Dermatology and Venerology
Wuppertal, Germany, D-42275
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
Siro Clinpharm Germany GmbH (until June 2013)
Accovion GmbH (from June 2013)
Investigators
Study Director: Ursula Petzold, Dr. MEDA Pharma GmbH & Co. KG
Principal Investigator: Harald Gollnick, Prof. Dr. Otto-von-Guericke-University of Magdeburg
  More Information

Additional Information:
No publications provided

Responsible Party: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01453179     History of Changes
Other Study ID Numbers: X-03016-3284, 2010-022054-16
Study First Received: September 30, 2011
Last Updated: July 2, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

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:
Carcinoma, Squamous Cell
Keratosis
Keratosis, Actinic
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Skin Diseases
Precancerous Conditions
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 23, 2014