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.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204542
First received: September 13, 2005
Last updated: August 18, 2011
Last verified: March 2009
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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 July 29, 2014