Clinical trial NCT00204542: 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
Official title: Comparison of the Efficacy and Tolerability of Solaraze for 3 vs. 6 Months in Patients With Mild to Moderate Actinic Keratosis Located at the Face and Head
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Photosensitivity Disorders
Keywords: actinic keratosis
diclofenac sodium
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Histologically controlled complete clearance of the actinic keratosis
timeFrame: 6 weeks after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
state: BW
city: Berlin
country: Germany
facility: Klinik fuer Dermatologie, Venerologie und Allergologie der Charite
city: Freiburg
country: Germany
facility: Dept. of Dermatology
city: Wuppertal
country: Germany
facility: Praxis Priv.-Doz. Dr. med. Dirschka
Study officials:
affiliation: Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
name: Claus Garbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson C, Rigel D, Smith S, Swanson N, Wolf J. Phase IV, open-label assessment of the treatment of actinic keratosis with 3.0% diclofenac sodium topical gel (Solaraze). J Drugs Dermatol. 2004 Jul-Aug;3(4):401-7.
citation: Rivers JK. Topical 3% diclofenac in 2.5% hyaluronan gel for the treatment of actinic keratoses. Skin Therapy Lett. 2004 Jan;9(1):1-3.