Back to resultsPhotodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:18 years or older, good health, more than 12 inflammatory facial acne lesions - Exclusion Criteria:skin type VI, pregnant or lactating woman. Oral retinoid use within one year, systemic antibiotics within 1 month, topical acne treatment within 2 weeks. -
Sites / Locations
- Bispebjerg Hospital
Outcomes
Primary Outcome Measures
Lesion counts (non-inflammatory and inflammatory)
Leeds Revised Acne Grading System
Secondary Outcome Measures
Pain
Side effects
Full Information
NCT ID
NCT00206895
First Posted
September 12, 2005
Last Updated
October 10, 2006
Sponsor
Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00206895
Brief Title
Photodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2004
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluated the efficacy and tolerability of methyl aminolevulinate and 5-aminolevulinic acid photodynamic therapy in patients with moderate to severe facial acne vulgaris in a randomized controlled and investigator blinded trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy
Primary Outcome Measure Information:
Title
Lesion counts (non-inflammatory and inflammatory)
Title
Leeds Revised Acne Grading System
Secondary Outcome Measure Information:
Title
Pain
Title
Side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:18 years or older, good health, more than 12 inflammatory facial acne lesions -
Exclusion Criteria:skin type VI, pregnant or lactating woman. Oral retinoid use within one year, systemic antibiotics within 1 month, topical acne treatment within 2 weeks.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Christian Wulf, MD, Sci
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Photodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study
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