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

Photosensitivity Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204542
• Other study ID #: ADO-Solaraze-AK-3-6
• Secondary ID: Eudra-CT-Nr. 200
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 18, 2011
• Start date: June 2005
• Est. completion date: December 2010

Study information

• Verified date: March 2009
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: December 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic
• Photosensitivity Disorders

Intervention

Drug:
• Diclofenac
Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
• Diclofenac
Solaraze® (Diclofenac sodium) 2x/day topical for 6 months

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologically controlled complete clearance of the actinic keratosis		6 weeks after end of treatment	No

External Links

•   Link to published abstract