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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00269074
First Posted: December 23, 2005
Last Update Posted: March 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
IDEA AG
  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
Intervention Model: Single Group Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00269074     History of Changes
Other Study ID Numbers: CL-070-II-02
EudrCT number: 2005-002875-34
First Submitted: December 22, 2005
First Posted: December 23, 2005
Last Update Posted: March 20, 2009
Last Verified: March 2009

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