Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

Actinic Keratosis Clinical Trial

— LEIDA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777127
• Other study ID #: X-03016-3271
• Secondary ID: 2007-004884-24
• Status: Completed
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	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
France	CHU St Jacques, Department for Dermatology	Besancon Cedex
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 Benite
Germany	Licca Clinical Research Institute	Augsburg
Germany	Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology	Berlin
Germany	Medical Practice Dominicus / Bockhorst	Duelmen
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	Hannover
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

Sponsors (1)

Lead Sponsor	Collaborator
MEDA Pharma GmbH & Co. KG

Countries where clinical trial is conducted

Austria,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to recurrence		3 years
Secondary	Long-term outcome with respect to development of SCC (in situ and/or invasive)		3 years
Secondary	Need of rescue treatment		3 years
Secondary	Haematological changes		20 weeks
Secondary	Cosmetic outcome.		3 years

External Links

•   European Dermatology Forum, Guidelines for the management of actinic keratoses. Last modified 26 Ocotober 2006.