Prospective, randomized, partly blinded, in part placebo-controlled, multicenter, dose-finding trial exploring safety, tolerability and efficacy of a topical resiquimod gel in patients with multiple actinic keratosis lesions

• Conditions: Actinic Keratosis; MedDRA version: 16.1Level: PTClassification code 10000614Term: Actinic keratosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-003943-23-DE
• Lead Sponsor: Spirig Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-24
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Signed informed consent
• Male or nonpregnant, nonlactating female, =18 years. For women of childbearing potential the use of highly effective methods of birth control (precautions to prevent pregnancy) is mandatory. Highly effective methods of birth control are defined as those, alone or in combination, which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly - such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. In this trial women of childbearing potential are instructed to use oral contraceptives or IUDs in combination with a barrier device (e.g. condom).
• A minimum of 2 clinically diagnosed AK-lesions within a 25 cm2 contiguous treatment area (balding scalp, forehead, face). One AK-lesion must have a diameter of at least 6 mm (indicator lesion).The patient may have been treated in the past for AK-lesions. But for the existing AK-lesions the restrictions for treatments before the start of the trial must be observed (see below exclusion criteria).
• Free of other significant findings in the treatment field that could impair examination of the treatment or surrounding area (defined as the area within a 5 cm margin of the treatment area
in all directions).
• Willing and able to participate in the trial as an outpatient and comply with all trial requirements.
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

• Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, gastrointestinal abnormalities or diseases).
• Evidence of an active infection.
• Evidence of immunosuppression or systemic cancer.
• Known autoimmune disorder (especially psoriasis), impaired immune system (e.g. HIV), known thyroid abnormalities, known depression.
• Dermatological disease or condition in the treatment or surrounding area that might be exacerbated by treatment with resiquimod gel or may impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
• Current alcohol abuse or chemical dependency as assessed by the investigator.
• Participation in another clinical trial within one month of trial entry.
• Known allergy or hypersensitivity to any of the trial gel ingredients.
• Pretreatments for the existing AK-lesions are restricted before the start of the trial, in the sense that different periods of grace must be observed:
• Local/topical treatments in the treatment area
• Dermabrasion, chemical peeling, laser treatment, cryotherapy or surgery within 6 weeks of trial entry
• Imiquimod, diclofenac, 5-Fluorouracil (5-FU), topical corticosteroids, topical retinoids, treatment of the head with ultraviolet B (UVB) or photodynamic treatment (PDT) within 6
weeks of trial entry
• Systemic treatments
• High-dose vitamin A (>15’000 units per day) within 2 weeks of trial entry
• Interferon/ interferon-inducers, immunosuppressors, immunomodulatory medicinal products, systemic (>10 mg/day) or high-dosed inhaled (>1600 µg/day) corticosteroids within 4 weeks of trial entry
• Chemotherapy or systemic retinoids within 6 months of trial entry.

Study & Design

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