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

• ClinicalTrials.gov Identifier: NCT00204542
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Last Update Posted: August 19, 2011
• Sponsor: University Hospital Tuebingen
• Information provided by: University Hospital Tuebingen

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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 

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
• Other Study ID Numbers: ADO-Solaraze-AK-3-6; Eudra-CT-Nr. 2004-002761-21
• First Posted: September 20, 2005
• Last Update Posted: August 19, 2011
• Last Verified: March 2009

Keywords provided by University Hospital Tuebingen:

actinic keratosis; diclofenac sodium

Additional relevant MeSH terms:

Keratosis, Actinic; Keratosis; Photosensitivity Disorders; Skin Diseases; Precancerous Conditions; Neoplasms; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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