Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

NCT00777127 | Completed Phase 4

• 2 other identifiers: X-03016-32712007-004884-24
• Study Type: interventional
• Target: 258
• Locations: 3 countries
• Sites: 26

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

Keywords

actinic keratosis; invasive SCC; in situ SCC; histological classification; histological progression; clinical clearance; cryotherapy

Outcome Measures

Primary Outcomes (1)

• Recurrence with respect to the study treatment area 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

  week 20 until month 12

Secondary Outcomes (5)

• Time to recurrence

  3 years

• Long-term outcome with respect to development of SCC (in situ and/or invasive)

  3 years

• Need of rescue treatment

  3 years

• Haematological changes

  20 weeks

• Cosmetic outcome.

  3 years

Study Arms (2)

1

EXPERIMENTAL

Aldara 5% Cream

Drug: Imiquimod

2

ACTIVE COMPARATOR

Solaraze 3% Gel

Drug: Diclofenac

Interventions

Imiquimod 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.

1

Diclofenac 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEDA Pharma GmbH & Co. KG: lead

Study Sites (26)

Hospital Feldkirch, Department for Dermatology and Venereology

Feldkirch, A-6807, Austria

Location

Medical University Graz, University Clinic for Dermatology and Venereology

Graz, A-8036, Austria

Location

Medical University Innsbruck, University Clinic for Dermatology and Venereology

Innsbruck, A-6020, Austria

Location

Medical University Vienna, Department for General Dermatology

Vienna, A-1090, Austria

Location

CHU St Jacques, Department for Dermatology

Besançon, F-25030, France

Location

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

Marseille, F-13009, France

Location

CHU Nice - Hospital Archet 2, Department for Dermatology

Nice, F-06202, France

Location

Hospital Saint-Louis, Derpartment for Dermatology

Paris, F-75010, France

Location

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

Pierre-Bénite, F-69495, France

Location

Licca Clinical Research Institute

Augsburg, D-86179, Germany

Location

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

Berlin, D-10117, Germany

Location

Medical Practice Dominicus / Bockhorst

Dülmen, D-48249, Germany

Location

Medical practice

Düsseldorf, D-40210, Germany

Location

University Clinic Düsseldorf, Clinic for Dermatology

Düsseldorf, D-40255, Germany

Location

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

Frankfurt am Main, D-60590, Germany

Location

SCiderm GmbH

Hamburg, D-20354, Germany

Location

Medical Practice

Hanover, D-30159, Germany

Location

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

Kiel, D-24105, Germany

Location

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

Magdeburg, D-39120, Germany

Location

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

Mainz, D-55131, Germany

Location

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

Mönchengladbach, D-41061, Germany

Location

University Clinic Münster, Clinic and Polyclinic for Skin Diseases

Münster, D-48149, Germany

Location

Clinic University Regensburg, Clinic and Polyclinic for Dermatology

Regensburg, D-93053, Germany

Location

Derma Center Vechta

Vechta, D-49377, Germany

Location

Centrovital

Witten, D-58453, Germany

Location

Medical practice for Dermatology and Venerology

Wuppertal, D-42275, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod; Diclofenac

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Harald Gollnick, MD, Prof.

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

  PRINCIPAL INVESTIGATOR

• Ursula Petzold, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: December 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 7, 2022

Record last verified: 2013-01

Locations

AU (4); FR (5); DE (17)