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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 terminated.
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00814918
First received: December 23, 2008
Last updated: April 14, 2009
Last verified: April 2009
History of Changes

December 23, 2008
April 14, 2009
February 2009
February 2013   (final data collection date for primary outcome measure)
Acne complete /incomplete therapy and reoccurence [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00814918 on ClinicalTrials.gov Archive Site
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation) [ Time Frame: 2-18 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris
Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acne Vulgaris
  • 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).
  • 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).
  • Experimental: 1
    5-ALA Application and exposure using Blu-U light to 1/2 of face.
    Intervention: Drug: 5-ALA with Blu-U Light
  • Experimental: 2
    5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face.
    Intervention: Drug: 5-ALA with Candela V-beam Pulse Dye Laser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
February 2014
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814918
15929B
No
Maria Tsoukas, MD - Assistant Professor Dermatology, The University of Chicago
University of Chicago
Not Provided
Principal Investigator: Maria Tsoukas, MD University of Chicago
University of Chicago
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP