Back to resultsEffect of IDEA-070 on Pain and Inflammation Induced by PDT
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
IDEA-070
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis
Eligibility 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
Sites / Locations
- Dermatological department of university hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00269074
Brief Title
Effect of IDEA-070 on Pain and Inflammation Induced by PDT
Official Title
Safety and Efficacy of IDEA-070 for the Treatment of Pain and Inflammation Induced by Photodynamic Therapy of Actinic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
IDEA AG
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
IDEA-070
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Reifenberger, PD Dr. med.
Organizational Affiliation
Dermatological department of university Duesseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatological department of university hospital
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
D-40225
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effect of IDEA-070 on Pain and Inflammation Induced by PDT
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