Actinic keratosis MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Imiquimod 5% cream
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Current Sponsor code:
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women and men = 18 years of age • Written consent to study participation after patient information by the investigator • Diagnosis of actinic keratosis according to generally accepted criteria • Presence of a (connected) area of approximately 25 cm² on either the face or balding scalp which requires medical treatment. • Identification of at least 5 and no more than 10 delimitable target lesions in the treatment area which have the following properties: mild to moderate clinical severity (grading I or II according to Olsen et al. [1991], modified according to Stockfleth et al. [2008]), diameter = 4 mm, not hypertrophic, not massively hyperkeratotic • For women of childbearing potential : Application of an efficient contraceptive method during the whole study •For women of childbearing potential: Pregnancy test with negative result prior to study start 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 426 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis vulgaris, rosacea papulopustulosa, squamous cell carcinoma, or other possible confounding skin conditions in the treatment area. • Presence of hypertrophic or massively hyperkeratotic AK lesions in the treatment area with grading III (according to Olsen et al. [1991], modified according to Stockfleth et al. [2008]) • Systemic therapy with retinoids within the last 6 months before study inclusion • Systemic treatment with immunosuppressive agents, interferon, glucocorticoids or cytostatics within the last 4 weeks prior to study treatment • Use of chemical peel, dermabrasion, laser abrasion, psoralen plus ultraviolet A (PUVA) therapy, and/or ultraviolet B (UVB) therapy in the treatment area in the last 6 months (180 days) • Use of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, masoprocol, or other treatments for AK in the treatment area in the last month (30 days) • Known intolerance or hypersensitivity against imiquimod or any of the other ingredients in the study medication • Other severe acute or chronic concomitant disease with severe impairment of the general condition • Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data • Reasonable doubt concerning the co-operation of the patient • Participation in another clinical study within the last 30 days prior to inclusion in this study • Participation in this study at an earlier date • Women with existing or intended pregnancy or during lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary efficacy endpoint to be analysed is the proportion of patients with clinical success, defined as a decrease of the TLNS of at least 75% between treatment start (Visit 1) and main examination (4 weeks post (final) treatment);Timepoint(s) of evaluation of this end point: Start of Treatment (Visit 1) and main examination (4 weeks post (final) treatment); Main Objective: Assessment of efficacy and safety of a new cream with imiquimod 5% in comparison with the approved preparation Aldara® 5% Cream and the underlying vehicle in patients with actinic keratosis. see also E5 (endpoints) ;Secondary Objective: see E5 (endpoints) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of patients with a 4 weeks treatment (course I) • Proportion of patients with a 4 weeks treatment (course I) followed by a 4 weeks treatment-free interval followed by a 4 weeks treatment (course II) • Proportion of patients with a decrease of the TLNS of at least 75% between treatment start (Visit 1) and Visit 3 and Visit 5, respectively • Proportion of patients with a decrease of the TLNS of 100% between treatment start (Visit 1) and the end of treatment (Visit 3 resp. Visit 5) and Visit 4/Visit 6, respectively • Changes in severity of the target lesions between Visit 1 (treatment start) and Visit 3, Visit 4, Visit 5 and Visit 6, respectively • Proportion of patients with Cumulative Lesions Number Score (CLNS) = 0; TLNS = 0 at Visit 3/ Visit 5 and Visit 4/Visit 6, respectively • Evaluation of overall therapeutic success by the investigator at Visit 4 and Visit 6, respectively ;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 above | — |
Countries
Germany
Contacts
Public ContactClinical Department
Dermapharm AG
Outcome results
None listed