Photodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study

October 10, 2006 updated by: Bispebjerg Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen NV
      • Copenhagen, Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lesion counts (non-inflammatory and inflammatory)
Leeds Revised Acne Grading System

Secondary Outcome Measures

Outcome Measure
Pain
Side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Study Director: Hans Christian Wulf, MD, Sci, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 11, 2006

Last Update Submitted That Met QC Criteria

October 10, 2006

Last Verified

October 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF-01-177/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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