Clinical trial to investigate clinical efficacy and tolerability of Tretinoin in actinic keratosis - Tretinoin bei AK

• Conditions: actinic keratosis; MedDRA version: 9.1Level: LLTClassification code 10000614Term: Actinic keratosis

• Registration Number: EUCTR2007-000093-23-DE
• Lead Sponsor: Almirall Hermal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

All of the following criteria have to be met for inclusion of a subject in the study:
•Male or female aged at least 18 years
•Patients with no more than 10 clinically assessed AK (face/ scalp, mild - moderate) in a treatment area of approx 10 x 10 cm
•Lesions with a grade of AK I + II ( acc to EDF guideline)
•Willingness to accept a 4 weeks washout-phase for e.g. 5-FU, Diclofenac or Imiquimod and to avoid extended UV-exposure during the study period
•Physical examination without further disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
•Skin type I – IV (Fitzpatrick)
•Women with childbearing potential must use a reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) like implants, injectables, combines oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner
•Pregnancy test negative
•Physical ability to apply the product correctly and to follow the study restrictions and visits
•Written informed consent obtained.

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

Subjects are to be excluded from the study when one or more of the following conditions are met:
•Current evidence of a Basal cell carcinoma, BCC or Squamous cell carcinoma, SCC in the treatment area
•Treatment with topical AK-treatment (e.g. Solaraze®, Efudix®, Aldara®,) within the past 4 weeks
•Treatment with PDT and/ or systemic Retinoids within the past 3 month
•Indication for a biopsy for histological diagnostic
•Cornu cutaneum like changes in the treatment area
•Erosions or ulcers in the application area
•Dermatological diseases in the target area, e.g. acute skin inflammation, acute eczema, rosacea, peri-oral dermatitis or hyper-pigmentation
•Simultaneous application of further topical products in the target area, e.g. BPO
•Immunosuppressive drugs (e.g. Methotrexat, Sulfonylurea)
•Pregnancy or breastfeeding
•Evidence of drug or alcohol abuse;
•Symptoms of another clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
•Participation in another clinical study in the 4 weeks preceding the study;
•Known allergic reactions to components of the study preparations, e.g. butylhydroxytoluol, cetylstearic alcohole, sorbin acid, propylene glycol, perfume
•Treatment with systemic or locally acting medications which might counter or influence the study aim
•Noneligibility for this study by discretion of the investigator or physician performing the initial examination, e.g. due to probable non-compliance or inability to understand the study or give adequately informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary variable improvement of clinical score” will be clinically measured and evaluated to investigate clinical efficacy of Tretinoin, marked as Cordes® VAS, in actinic keratosis. Additionally standardised photo documentation at baseline, interim visit and final visit will be performed. <br><br>;Secondary Objective: Secondary variables (tolerability/ safety, compliance plus patient’s assessment of tolerability and efficacy) will be scored by Physician Global Assessment, PGA, Patient Global Assessment and standard clinical scores. Treatment compliance will be checked by control of trial samples. <br>;Primary end point(s): Primary objective is the improvement of actinic lesions measured by clinical grading of individual target lesions