Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

NCT ID: NCT00777127

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-11-30

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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Aldara 5% Cream

Group Type: EXPERIMENTAL

Imiquimod

Intervention Type: DRUG

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.

2

Solaraze 3% Gel

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEDA Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harald Gollnick, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology

Ursula Petzold, PhD

Role: STUDY_DIRECTOR

MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany

Locations

Hospital Feldkirch, Department for Dermatology and Venereology

Feldkirch, , Austria

Medical University Graz, University Clinic for Dermatology and Venereology

Graz, , Austria

Medical University Innsbruck, University Clinic for Dermatology and Venereology

Innsbruck, , Austria

Medical University Vienna, Department for General Dermatology

Vienna, , Austria

CHU St Jacques, Department for Dermatology

Besançon, , France

Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor

Marseille, , France

CHU Nice - Hospital Archet 2, Department for Dermatology

Nice, , France

Hospital Saint-Louis, Derpartment for Dermatology

Paris, , France

Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology

Pierre-Bénite, , France

Licca Clinical Research Institute

Augsburg, , Germany

Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology

Berlin, , Germany

Medical Practice Dominicus / Bockhorst

Dülmen, , Germany

Medical practice

Düsseldorf, , Germany

University Clinic Düsseldorf, Clinic for Dermatology

Düsseldorf, , Germany

Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology

Frankfurt am Main, , Germany

SCiderm GmbH

Hamburg, , Germany

Medical Practice

Hanover, , Germany

University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology

Kiel, , Germany

Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology

Magdeburg, , Germany

Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center

Mainz, , Germany

Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics

Mönchengladbach, , Germany

University Clinic Münster, Clinic and Polyclinic for Skin Diseases

Münster, , Germany

Clinic University Regensburg, Clinic and Polyclinic for Dermatology

Regensburg, , Germany

Derma Center Vechta

Vechta, , Germany

Centrovital

Witten, , Germany

Medical practice for Dermatology and Venerology

Wuppertal, , Germany

Countries

Austria; France; Germany

Other Identifiers

2007-004884-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

X-03016-3271

Identifier Type: -

Identifier Source: org_study_id