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Effect of IDEA-070 on Pain and Inflammation Induced by PDT

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00269074
First received: December 22, 2005
Last updated: March 19, 2009
Last verified: March 2009
History of Changes
  Purpose

Primary objectives: effect of IDEA-070 compared to placebo on pain and inflammation induced by PDT. The primary objective is to detect a statistically significant difference of pain and inflammation induced by PDT in test areas treated with IDEA-070 compared to placebo-treated areas.


Condition Intervention Phase
Actinic Keratosis
 Drug: IDEA-070
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety and Efficacy of IDEA-070 for the Treatment of Pain and Inflammation Induced by Photodynamic Therapy of Actinic Keratosis

Further study details as provided by IDEA AG:

Estimated Enrollment: 24
Study Start Date: January 2006
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269074

Locations
Germany
Dermatological department of university hospital
Duesseldorf, Nordrhein-Westfalen, Germany, D-40225
Sponsors and Collaborators
IDEA AG
Investigators
Principal Investigator: Julia Reifenberger, PD Dr. med. Dermatological department of university Duesseldorf
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00269074     History of Changes
Other Study ID Numbers: CL-070-II-02, EudrCT number: 2005-002875-34
Study First Received: December 22, 2005
Last Updated: March 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Inflammation
Keratosis
Keratosis, Actinic
Pathologic Processes
 Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013