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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
  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:

MedlinePlus related topics: Acne
U.S. FDA Resources

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
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
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Aminolevulinic Acid
 Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013