E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Start of Treatment (Visit 1) and main examination (4 weeks post (final) treatment) |
|
E.5.2 | 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
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Depends on the secondary endpoint, see E.5.2 above |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |