Clinical trial NCT00777127: Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Keywords: actinic keratosis
invasive SCC
in situ SCC
histological classification
histological progression
clinical clearance
cryotherapy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Recurrence with respect to the study treatment area until month 12
timeFrame: week 20 until month 12
Secondary outcomes:
measure: Time to recurrence
timeFrame: 3 years
measure: Long-term outcome with respect to development of SCC (in situ and/or invasive)
timeFrame: 3 years
measure: Need of rescue treatment
timeFrame: 3 years
measure: Haematological changes
timeFrame: 20 weeks
measure: Cosmetic outcome.
timeFrame: 3 years
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Hospital Feldkirch, Department for Dermatology and Venereology
city: Graz
country: Austria
facility: Medical University Graz, University Clinic for Dermatology and Venereology
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, University Clinic for Dermatology and Venereology
city: Vienna
country: Austria
facility: Medical University Vienna, Department for General Dermatology
city: Besancon Cedex
country: France
facility: CHU St Jacques, Department for Dermatology
city: Marseille
country: France
facility: Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor
city: Nice
country: France
facility: CHU Nice - Hospital Archet 2, Department for Dermatology
city: Paris
country: France
facility: Hospital Saint-Louis, Derpartment for Dermatology
city: Pierre Benite
country: France
facility: Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology
city: Augsburg
country: Germany
facility: Licca Clinical Research Institute
city: Berlin
country: Germany
facility: Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology
city: Duelmen
country: Germany
facility: Medical Practice Dominicus / Bockhorst
city: Düsseldorf
country: Germany
facility: Medical practice
city: Düsseldorf
country: Germany
facility: University Clinic Düsseldorf, Clinic for Dermatology
city: Frankfurt am Main
country: Germany
facility: Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology
city: Hamburg
country: Germany
facility: SCiderm GmbH
city: Hannover
country: Germany
facility: Medical Practice
city: Kiel
country: Germany
facility: University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology
city: Magdeburg
country: Germany
facility: Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology
city: Mainz
country: Germany
facility: Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center
city: Mönchengladbach
country: Germany
facility: Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics
city: Münster
country: Germany
facility: University Clinic Münster, Clinic and Polyclinic for Skin Diseases
city: Regensburg
country: Germany
facility: Clinic University Regensburg, Clinic and Polyclinic for Dermatology
city: Vechta
country: Germany
facility: Derma Center Vechta
city: Witten
country: Germany
facility: Centrovital
city: Wuppertal
country: Germany
facility: Medical practice for Dermatology and Venerology
Study officials:
affiliation: Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology
name: Harald Gollnick, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany
name: Ursula Petzold, PhD
role: STUDY_DIRECTOR
References: