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

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00814918

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

MedlinePlus related topics: Acne

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris

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
1: Experimental 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).
2: Experimental 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

Contacts

Contact: Christina Sprayberry

773-702-2962

christinas@uchicago.edu

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:	The University of Chicago ( Maria Tsoukas, MD - Assistant Professor Dermatology )
Study ID Numbers:	15929B
Study First Received:	December 23, 2008
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00814918
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

acne vulgaris
acne
dermatalogy

Study placed in the following topic categories:

Exanthema
Facial Dermatoses
Facies
Skin Diseases

Sebaceous Gland Diseases
Acne Vulgaris
Aminolevulinic Acid

Additional relevant MeSH terms:

Acneiform Eruptions

ClinicalTrials.gov processed this record on January 15, 2009