Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2008
CompletedFirst Posted
Study publicly available on registry
December 25, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedDecember 4, 2014
December 1, 2014
4 years
December 23, 2008
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acne complete /incomplete therapy and reoccurence
18 months
Secondary Outcomes (1)
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
2-18 months
Study Arms (2)
1
EXPERIMENTAL5-ALA Application and exposure using Blu-U light to 1/2 of face.
2
EXPERIMENTAL5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face.
Interventions
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).
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Tsoukas, MD
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2008
First Posted
December 25, 2008
Study Start
February 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2014
Last Updated
December 4, 2014
Record last verified: 2014-12