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Safety and Efficacy of IDEA-070 for the Treatment of Pain and Inflammation Induced by Photodynamic Therapy of Actinic Keratosis


Phase 2
18 Years
85 Years
Not Enrolling
Both
Actinic Keratosis

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Trial Information

Safety and Efficacy of IDEA-070 for the Treatment of Pain and Inflammation Induced by Photodynamic Therapy of Actinic Keratosis


Inclusion Criteria:



Diagnosis ot actinic keratosis to be treated with PDT affecting equal sized areas of both
sides of the head affecting at least 10% of the area of photoexposure

Exclusion Criteria:

Morpheaform basal cell carcinoma, Major hypertrophy of lesions, Porphyria, Topical
treatment with 5-FU, cryotherapy, PDT, diclophenac sodium, and other less common
treatments on the treatment area or systemic treatment within 3 month prior to screening,
Concomitant use of other analgesics including topical NSAIDs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Julia Reifenberger, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dermatological department of university Duesseldorf

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CL-070-II-02

NCT ID:

NCT00269074

Start Date:

January 2006

Completion Date:

July 2006

Related Keywords:

  • Actinic Keratosis
  • Inflammation
  • Keratosis
  • Keratosis, Actinic

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