Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head

University Hospital Tuebingen

Status and phase

Completed

Phase 4

Conditions

Photosensitivity Disorders

Treatments

Drug: Diclofenac

Study type

Interventional

Funder types

Other

Identifiers

NCT00204542

Eudra-CT-Nr. 2004-002761-21

ADO-Solaraze-AK-3-6

Details and patient eligibility

About

Topical treatment of mild to moderate actinic keratosis located on the face and head with Solaraze® is known to be a safe and efficient treatment option. However, it is unclear if an expansion of the treatment period to 6 months will increase the rate of complete responses.

Therefore the investigators will evaluate the efficacy and safety of the treatment of actinic keratosis with Solaraze® applied twice daily to the face and head over 3 or 6 months of treatment.

Enrollment

418 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Visible and histologically proven actinic keratosis
Prepared and able to give written informed consent
≥ 18 -80 years of age
Prepared and comply with all study requirements, including the following: application of gel on the treatment area twice a day, 5 / 7 clinic visits during the prestudy, treatment, posttreatment, and follow-up period
Pre- and posttreatment biopsy for histological confirmation (of clearance) of actinic keratosis diagnosis

Exclusion criteria

Data of clinically significant, unstable, cardiovascular or haematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases
Known allergies to any excipient in the study drug
Any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with diclofenac or cause difficulty with examination
Active chemical dependency or alcoholism, as assessed by the investigator
Currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days
Received topical treatment at the treatment area with imiquimod or 5-FU within a time period of 1 month
Invasive tumours within the treatment area, e.g. merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed