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NCT00269074 Clinical Trial

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

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00269074
Other study ID # CL-070-II-02
Secondary ID EudrCT number: 2
Status Completed
Phase Phase 2
First received December 22, 2005
Last updated March 19, 2009
Start date January 2006
Est. completion date July 2006

Study information
Verified date March 2009
Source IDEA AG
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• IDEA-070

Locations
Country Name City State
Germany Dermatological department of university hospital Duesseldorf Nordrhein-Westfalen

Sponsors (1)
Lead Sponsor Collaborator
IDEA AG

Country where clinical trial is conducted

Germany, 

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