ong-term effects of Aldara® 5% cream and Solaraze® 3% gel in the treatment of actinic keratoses on the face or scalp (LEIDA) - LEIDA (Long-term effects of Imiquimod and Diclofenac in Actinic keratoses)

Phase 1

• Conditions: This study will investigate the long term effects of Aldara® and Solaraze® on Actinic keratoses (AKs) on the face or scalp. AKs are defined as keratotic macules, papules or plaques with superficial scale on a red base, occurring on areas of extensive damage through sunlight. AKs are mainly induced by non-ionised radiation, especially through chronic UV-exposition, primarily sunlight.; MedDRA version: 9.1Level: LLTClassification code 10000614Term: Actinic keratosis

• Registration Number: EUCTR2007-004884-24-FR
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-20
• Study Completion: 2012-11-20
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

To be eligible, a patient must comply with all of the following criteria:
1.Immunocompetent patient.
2.A study treatment area (STA) 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.
3.A positive histological finding for early in situ SCC type AK I or II. 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.
4.Willingness to comply with the obligations of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient is ineligible and must not enter the study if any of the following criteria is met:
Safety concerns:
1.History of allergic reaction to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.
2.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:
3.Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
4.Persisting AK lesion following topical treatment with imiquimod or diclofenac in the STA present at screening visit.
5.Presence of any histologically confirmed skin tumour in the STA: in situ SCC type AK III, Bowen’s disease, invasive squamous cell carcinoma, basal cell carcinoma or other malignant tumours.
6.Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
7.Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
8.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.
9.Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.
10.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.
11.History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
12.History of any malignant skin tumour actively treated by chemotherapy or retinoids.
13.History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.
14.Mentally incapacitated patient.
15.Present or history of drug or alcohol abuse within the last 3 years.
Administrative reasons:
16.Exposure to an investigational product within the last 3 months.
17.Lack of ability or willingness to give informed consent.
18.Age below 18 years.
19.Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
20.Anticipated non-availability for study visits/procedures.
21.Vulnerable subjects (such as persons kept in detention).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare the long-term outcome of treatment with Aldara® 5% cream (IMIQ) and Solaraze® 3% gel (DIC) regarding recurrence rates.;Secondary Objective: Secondary objectives include the time to recurrence, long-term clinical outcome with respect to development of invasive SCC (squamous cell carcinoma), progression of SCC, need of rescue treatment, haematological changes, and cosmetic outcome.;Primary end point(s): The primary efficacy variable (endpoint) is the (patient) recurrence rate with respect to the STA. A patient is classified as recurrent when cleared at Week 20 and having clinically at least one evident AK lesion in the STA later on.