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NCT00206895 Clinical Trial

Photodynamic Therapy of Acne Vulgaris - a Randomized Blinded Controlled Study

Acne Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00206895
Other study ID # KF-01-177/04
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated October 10, 2006
Start date November 2004

Study information
Verified date October 2004
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Photodynamic therapy

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen Copenhagen NV

Sponsors (1)
Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lesion counts (non-inflammatory and inflammatory)
Primary Leeds Revised Acne Grading System
Secondary Pain
Secondary Side effects
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