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
Information source: University Hospital Tuebingen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Photosensitivity Disorders
Intervention: Diclofenac (Drug); Diclofenac (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital Tuebingen Official(s) and/or principal investigator(s): Claus Garbe, MD, Principal Investigator, Affiliation: Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Histologically controlled complete clearance of the actinic keratosis
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Klinik fuer Dermatologie, Venerologie und Allergologie der Charite, Berlin 10117, Germany
Dept. of Dermatology, Freiburg 79104, Germany
Praxis Priv.-Doz. Dr. med. Dirschka, Wuppertal, Germany
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8, Tübingen, BW 72076, Germany
Additional Information
Link to published abstract
Related 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.
Starting date: June 2005
Last updated: August 18, 2011
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