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

Overview

No summary available.

Registry

who.int

Start Date

July 24, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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)