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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

Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00814918
Enrollment
0
Registered
2008-12-25
Start date
2009-02-28
Completion date
2014-02-28
Last updated
2014-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

acne vulgaris, acne, dermatalogy

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.

Interventions

DRUG5-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).

DRUG5-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).

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
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.

Design outcomes

Primary

MeasureTime frame
Acne complete /incomplete therapy and reoccurence18 months

Secondary

MeasureTime frame
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)2-18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026