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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

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

Page last updated: August 23, 2015

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