Comparision 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
Information source: University Hospital Tuebingen
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Photosensitivity Disorders
Intervention: Solaraze® (Diclofenac sodium) (Drug); dicofenac (Drug); diclofenac (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital Tuebingen Official(s) and/or principal investigator(s):
Claus Garbe, MD, Principal Investigator, Affiliation: Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
Overall contact:
Claus Garbe, MD, Phone: ++49 7071 29 87110, Email: claus.garbe@med.uni-tuebingen.de
Summary
Topical treatment of mild to moderate actinic keratosis located at 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 we evaluate the efficacy and safety of the treatment of actinic keratosis with
Solaraze® applied twice a day in face and head over 3 or 6 months of treatment.
Clinical Details
Official title: Comparision 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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Histologically controlled complete clearance of the actinic keratosis
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Claus Garbe, MD, Phone: ++49 7071 29 87110, Email: claus.garbe@med.uni-tuebingen.de
Dept. of Dermatology, Freiburg 79104, Germany; Recruiting
Dorothee Nashan, Prof. Dr., Phone: 0761 270-6749, Email: dorothee.nashan@uniklinik-freiburg.de
Dorothee Nashan, Prof. Dr., Principal Investigator
Klinik fuer Dermatologie, Venerologie und Allergologie der Charite, Berlin 10117, Germany; Recruiting
Eggert Stockfleth, Prof. Dr., Email: eggert.stockfleth@charite.de
Eggert Stockfleth, Prof. Dr., Principal Investigator
Praxis Priv.-Doz. Dr. med. Dirschka, Wuppertal, Germany; Recruiting
Thomas Dirschka, PhD, Email: drdirschka@aol.com
Thomas Dirschka, PhD, Principal Investigator
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8, Tübingen, BW 72076, Germany; Recruiting
Claus Garbe, MD, Phone: ++49 7071 29 87110, Email: claus.garbe@med.uni-tuebingen.de
Claus Garbe, MD, Principal Investigator
Benjamin Weide, MD, Sub-Investigator
Thomas Eigentler, MD, Sub-Investigator
Annette Pflugfelder, MD, Sub-Investigator
Additional Information
Related publications: 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. 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.
Starting date: June 2005
Ending date: April 2007
Last updated: December 5, 2007
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