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

This study has been completed.

First Received on September 13, 2005. Last Updated on August 18, 2011 History of Changes

Sponsor:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00204542

Purpose

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.

Condition	Intervention	Phase
Photosensitivity Disorders	Drug: Diclofenac	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Histologically controlled complete clearance of the actinic keratosis [ Time Frame: 6 weeks after end of treatment ] [ Designated as safety issue: No ]

Enrollment:	418
Study Start Date:	June 2005
Study Completion Date:	December 2010
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Solaraze(R) 2x/day for 3 months	Drug: Diclofenac Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
Active Comparator: B Solaraze(R) 2x/day for 6 months	Drug: Diclofenac Solaraze® (Diclofenac sodium) 2x/day topical for 6 months

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204542

Locations

Germany
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
Tübingen, BW, Germany, 72076
Klinik fuer Dermatologie, Venerologie und Allergologie der Charite
Berlin, Germany, 10117
Dept. of Dermatology
Freiburg, Germany, 79104
Praxis Priv.-Doz. Dr. med. Dirschka
Wuppertal, Germany

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Claus Garbe, MD

Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

More Information

Additional Information:

Link to published abstract This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Prof. Dr. Claus Garbe, DECOG
ClinicalTrials.gov Identifier:	NCT00204542 History of Changes
Other Study ID Numbers:	ADO-Solaraze-AK-3-6, Eudra-CT-Nr. 2004-002761-21
Study First Received:	September 13, 2005
Last Updated:	August 18, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

actinic keratosis
diclofenac sodium

Additional relevant MeSH terms:

Keratosis
Keratosis, Actinic
Photosensitivity Disorders
Dermatitis, Phototoxic
Epilepsy, Reflex
Skin Diseases
Precancerous Conditions
Neoplasms
Dermatitis, Irritant
Dermatitis, Contact
Dermatitis
Skin Diseases, Eczematous
Epilepsy
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012