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Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)

NCT00933543 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2013-12-11

Study results available
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Summary

The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from 9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream without occlusion and red light(dose: 37J/cm2)

Conditions

  • Acne Vulgaris

Interventions

DRUG

Visonac PDT (MAL PDT)

Cream application followed by illumination with red light.

DRUG

Vehicle cream (placebo)

Cream application followed by illumination with red light.

PROCEDURE

PDT

Photodynamic Therapy - Light dose 37 J/cm2

Sponsors & Collaborators

  • Photocure

    lead INDUSTRY

Principal Investigators

  • Lawrence F. Eichenfield, M.D · Children's Specialists of San Diego / Rady Children's Hospital San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00933543 on ClinicalTrials.gov