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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms
Pathologic Processes
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014