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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204542
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 19, 2011
Information provided by:
University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Photosensitivity Disorders Drug: Diclofenac Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
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
Study Start Date : June 2005
Actual Primary Completion Date : March 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Histologically controlled complete clearance of the actinic keratosis [ Time Frame: 6 weeks after end of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204542

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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
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Principal Investigator: Claus Garbe, MD Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
Additional Information:
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Responsible Party: Prof. Dr. Claus Garbe, DECOG Identifier: NCT00204542    
Other Study ID Numbers: ADO-Solaraze-AK-3-6
Eudra-CT-Nr. 2004-002761-21
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: March 2009
Keywords provided by University Hospital Tuebingen:
actinic keratosis
diclofenac sodium
Additional relevant MeSH terms:
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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