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

NCT ID: NCT00814918

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

5-ALA Application and exposure using Blu-U light to 1/2 of face.

Group Type EXPERIMENTAL

5-ALA with Blu-U Light

Intervention Type DRUG

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

5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face.

Group Type EXPERIMENTAL

5-ALA with Candela V-beam Pulse Dye Laser

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Tsoukas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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15929B

Identifier Type: -

Identifier Source: org_study_id