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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00777127
Recruitment Status : Completed
First Posted : October 22, 2008
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG

Brief Summary:
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 or disease Intervention/treatment Phase
Actinic Keratosis Drug: Imiquimod Drug: Diclofenac Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Recurrence with respect to the study treatment area until month 12 [ Time Frame: week 20 until month 12 ]
    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 :
  1. Time to recurrence [ Time Frame: 3 years ]
  2. Long-term outcome with respect to development of SCC (in situ and/or invasive) [ Time Frame: 3 years ]
  3. Need of rescue treatment [ Time Frame: 3 years ]
  4. Haematological changes [ Time Frame: 20 weeks ]
  5. Cosmetic outcome. [ Time Frame: 3 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00777127

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Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
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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
Additional Information:
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Responsible Party: MEDA Pharma GmbH & Co. KG Identifier: NCT00777127    
Other Study ID Numbers: X-03016-3271
2007-004884-24 ( EudraCT Number )
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013
Keywords provided by MEDA Pharma GmbH & Co. KG:
actinic keratosis
invasive SCC
in situ SCC
histological classification
histological progression
clinical clearance
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Antineoplastic Agents
Interferon Inducers