This study will compare the long term effects of Aldara® and Solaraze® of the actinic keratoses on the face or scalp. Actinic keratoses (AKs) are defined as keratotic macules, papules or plaques with superficial scale on a red base, occurring on areas of extensive damage through sunlight. AKs are mainly induced by non-ionised radiation, especially through chronic UV-exposition, primarily sunlight. MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ
Conditions
Interventions
Trade Name: Aldara® 5% Cream
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Current Sponsor code: IMIQ
Other descriptive name: 1-(2-methylpropyl)-1H-imidazo[4,5-c]qui
Sponsors
MEDA Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Immunocompetent patient. 2. 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. 3. 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. 4. Willingness to comply with the obligations of the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to imiquimod, diclofenac, acetyl salicylic acid, other non-steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients. 2. 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. 1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment. 10. History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy). 11. History of any malignant skin tumour having metastasised or in which metastasis within the study period is likely. 12. 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. 13. Mentally incapacitated patient. 14. Present or history of drug or alcohol abuse within the last 3 years. Administrative reasons: 15. Exposure to an investigational product within the last 3 months. 16. Lack of ability or willingness to give informed consent. 17. Age below 18 years. 18. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol. 19. Anticipated non-availability for study visits/procedures. 20. Vulnerable subjects (such as persons kept in detention).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the 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 X-03016-3271).;Secondary Objective: Secondary objectives include recurrence rates, the time to recurrence, need of rescue treatment, and cosmetic outcome.;Primary end point(s): The histological finding of an in situ SCC or an invasive SCC after start of treatment will be considered as "histological progression", which is the primary efficacy variable ("endpoint").;Timepoint(s) of evaluation of this end point: 20 weeks after start of each treatment cycle until month 36. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2) Histological classification. 3) 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 STA. 4) Incidence of withdrawals from study treatment due to lack of efficacy. 5) Percent clinical clearance (complete = 100%, partial = 75%, and individual clearance) of baseline AK lesions in the study treatment area 8 weeks after end of treatment and at Week 20. 6) Lesion clearance 8 weeks after end of treatment and at Week 20. 7) Number of treatment cycles per patient in the STA during the study. 8) Number of patients with cryotherapy in the STA during the study. 9) Number of cryotherapies in the STA by patient. 10) Total number of lesions treated with cryotherapy in the STA during the study. 11) Cosmetic outcome (investigator and patient) at Week 20 and then at Month 12, 18, 24, 30 and 36. 12) Local skin reactions. 13) Adverse events of special interest. 14) Other adverse events.;Timepoint(s) of evaluation of this end point: 2) 20 weeks after start of each treatment cycle until month 36. 3,7) at least half-yearly until m36. 4,8,9,10) at any visit until m36. 5,6) 8 weeks after end of treatment and at Week 20. 11) at Week 20 and then at at least half-yearly until m36. 12,13,14) at each visit until m36. | — |
Countries
Austria, Germany
Contacts
Public ContactClinical Research
MEDA Pharma GmbH & Co KG
Outcome results
None listed