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Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814918
First Posted: December 25, 2008
Last Update Posted: December 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
  Purpose
The goal of this study is to compare how efficient two different types of PDTs are when used in combination with topical 5-ALA. The two types of PDT lights are Blu-U light and Candela V-beam Pulse Dye Laser.

Condition Intervention
Acne Vulgaris Drug: 5-ALA with Blu-U Light Drug: 5-ALA with Candela V-beam Pulse Dye Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Acne complete /incomplete therapy and reoccurence [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation) [ Time Frame: 2-18 months ]

Enrollment: 0
Study Start Date: February 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5-ALA Application and exposure using Blu-U light to 1/2 of face.
Drug: 5-ALA with Blu-U Light
20% 5-ALA Levulan Kerastick will be crushed and prepared for application after shaking for at least 3 minutes. Topical 5-ALA will be applied liberally on skin with extra pressure on lesions.Skin will be exposed to DUSA Blu-U light (417nm).
Experimental: 2
5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face.
Drug: 5-ALA with Candela V-beam Pulse Dye Laser
20% 5-ALA Levulan Kerastick will be crushed and prepared for application after shaking for at least 3 minutes. Topical 5-ALA will be applied liberally on skin with extra pressure on lesions.Skin will be exposed to Candela V-beam Pulsed Dye Laser (595 nm).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-79 years of age
  • Patients who failed the topical and oral antibiotics after 6 month therapy.
  • Patients who failed the topical retinoids after 6 month therapy.
  • Patients that are not good candidate to start oral isotretinoin (Accutane) due to contraindications.

Exclusion Criteria:

  • Patients who have had Isotretinoin therapy less that 1 year prior to this ALA-PDT procedure.
  • Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
  • Patients with a history of porphyria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814918


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Maria Tsoukas, MD University of Chicago
  More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00814918     History of Changes
Other Study ID Numbers: 15929B
First Submitted: December 23, 2008
First Posted: December 25, 2008
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by University of Chicago:
acne vulgaris
acne
dermatalogy

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents