NCT00206895

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2004

First QC Date

September 12, 2005

Last Update Submit

October 10, 2006

Conditions

Outcome Measures

Primary Outcomes (2)

  • Lesion counts (non-inflammatory and inflammatory)

  • Leeds Revised Acne Grading System

Secondary Outcomes (2)

  • Pain

  • Side effects

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Hans Christian Wulf, MD, Sci

    Bispebjerg Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Last Updated

October 11, 2006

Record last verified: 2004-10

Locations