Clinical study to compare two creams with the active substance imiquimod and one cream without active substance for patients with actinic keratosis

Phase 1

• Conditions: Actinic keratosis; MedDRA version: 20.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-000712-15-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-14
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 426

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

• 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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);<br> 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.<br> <br> see also E5 (endpoints)<br> ;Secondary Objective: see E5 (endpoints)