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

August 18, 2011 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

418

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 10117
        • Klinik fuer Dermatologie, Venerologie und Allergologie der Charite
      • Freiburg, Germany, 79104
        • Dept. of Dermatology
      • Wuppertal, Germany
        • Praxis Priv.-Doz. Dr. med. Dirschka
    • BW
      • Tübingen, BW, Germany, 72076
        • Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Solaraze(R) 2x/day for 3 months
Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
Solaraze® (Diclofenac sodium) 2x/day topical for 6 months
Active Comparator: B
Solaraze(R) 2x/day for 6 months
Solaraze® (Diclofenac sodium) 2x/day topical for 3 months
Solaraze® (Diclofenac sodium) 2x/day topical for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histologically controlled complete clearance of the actinic keratosis
Time Frame: 6 weeks after end of treatment
6 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Claus Garbe, MD, Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

March 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Photosensitivity Disorders

Clinical Trials on Diclofenac

3
Subscribe