Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris
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ClinicalTrials.gov Identifier: NCT00814918 |
Recruitment Status :
Withdrawn
First Posted : December 25, 2008
Last Update Posted : December 4, 2014
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Condition or disease | Intervention/treatment | Phase |
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Acne Vulgaris | Drug: 5-ALA with Blu-U Light Drug: 5-ALA with Candela V-beam Pulse Dye Laser | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | February 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
5-ALA Application and exposure using Blu-U light to 1/2 of face.
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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.
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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). |
- Acne complete /incomplete therapy and reoccurence [ Time Frame: 18 months ]
- Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation) [ Time Frame: 2-18 months ]

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Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814918
United States, Illinois | |
The University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | Maria Tsoukas, MD | University of Chicago |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00814918 |
Other Study ID Numbers: |
15929B |
First Posted: | December 25, 2008 Key Record Dates |
Last Update Posted: | December 4, 2014 |
Last Verified: | December 2014 |
acne vulgaris acne dermatalogy |
Acne Vulgaris Acneiform Eruptions Skin Diseases Sebaceous Gland Diseases |
Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents |