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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
  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: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maria Tsoukas, MD - Assistant Professor Dermatology, The University of Chicago
ClinicalTrials.gov Identifier: NCT00814918     History of Changes
Other Study ID Numbers: 15929B
Study First Received: December 23, 2008
Last Updated: April 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
acne vulgaris
acne
dermatalogy

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Aminolevulinic Acid
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014