LEIDA: Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

Sponsor

MEDA Pharma GmbH & Co. KG (Industry)

Overall Status

Completed

CT.gov ID

NCT00777127

Collaborator

(none)

258

Enrollment

Locations

Arms

Duration (Months)

9.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratosis	Drug: Imiquimod Drug: Diclofenac	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Aldara 5% Cream	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.
Active Comparator: 2 Solaraze 3% Gel	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.

Arm

Intervention/Treatment

Experimental: 1

Aldara 5% Cream

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.

Active Comparator: 2

Solaraze 3% Gel

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.

Outcome Measures

Primary Outcome Measures

Recurrence with respect to the study treatment area until month 12 [week 20 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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital Feldkirch, Department for Dermatology and Venereology	Feldkirch	Austria	A-6807
2	Medical University Graz, University Clinic for Dermatology and Venereology	Graz	Austria	A-8036
3	Medical University Innsbruck, University Clinic for Dermatology and Venereology	Innsbruck	Austria	A-6020
4	Medical University Vienna, Department for General Dermatology	Vienna	Austria	A-1090
5	CHU St Jacques, Department for Dermatology	Besancon Cedex	France	F-25030
6	Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor	Marseille	France	F-13009
7	CHU Nice - Hospital Archet 2, Department for Dermatology	Nice	France	F-06202
8	Hospital Saint-Louis, Derpartment for Dermatology	Paris	France	F-75010
9	Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology	Pierre Benite	France	F-69495
10	Licca Clinical Research Institute	Augsburg	Germany	D-86179
11	Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology	Berlin	Germany	D-10117
12	Medical Practice Dominicus / Bockhorst	Duelmen	Germany	D-48249
13	Medical practice	Düsseldorf	Germany	D-40210
14	University Clinic Düsseldorf, Clinic for Dermatology	Düsseldorf	Germany	D-40255
15	Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology	Frankfurt am Main	Germany	D-60590
16	SCiderm GmbH	Hamburg	Germany	D-20354
17	Medical Practice	Hannover	Germany	D-30159
18	University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology	Kiel	Germany	D-24105
19	Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology	Magdeburg	Germany	D-39120
20	Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center	Mainz	Germany	D-55131
21	Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics	Mönchengladbach	Germany	D-41061
22	University Clinic Münster, Clinic and Polyclinic for Skin Diseases	Münster	Germany	D-48149
23	Clinic University Regensburg, Clinic and Polyclinic for Dermatology	Regensburg	Germany	D-93053
24	Derma Center Vechta	Vechta	Germany	D-49377
25	Centrovital	Witten	Germany	D-58453
26	Medical practice for Dermatology and Venerology	Wuppertal	Germany	D-42275

Sponsors and Collaborators

MEDA Pharma GmbH & Co. KG

Investigators

Principal Investigator: Harald Gollnick, MD, Prof., Otto-von-Guericke-University of Magdeburg/Germany, Clinic for Dermatology and Venereology
Study Director: Ursula Petzold, PhD, MEDA Pharma GmbH & Co. KG, Bad Homburg/Germany