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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


Phase 4
18 Years
80 Years
Not Enrolling
Both
Photosensitivity Disorders

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Histologically controlled complete clearance of the actinic keratosis

Outcome Time Frame:

6 weeks after end of treatment

Safety Issue:

No

Principal Investigator

Claus Garbe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ADO-Solaraze-AK-3-6

NCT ID:

NCT00204542

Start Date:

June 2005

Completion Date:

December 2010

Related Keywords:

  • Photosensitivity Disorders
  • actinic keratosis
  • diclofenac sodium
  • Keratosis
  • Keratosis, Actinic
  • Photosensitivity Disorders
  • Dermatitis, Phototoxic
  • Epilepsy, Reflex

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