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

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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00204542

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
Principal Investigator: Claus Garbe, MD Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
  More Information

Additional Information:
Responsible Party: Prof. Dr. Claus Garbe, DECOG 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

Keywords provided by University Hospital Tuebingen:
actinic keratosis
diclofenac sodium

Additional relevant MeSH terms:
Keratosis, Actinic
Photosensitivity Disorders
Skin Diseases
Precancerous Conditions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017