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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

Primary Purpose

Acne Vulgaris

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-ALA with Blu-U Light
5-ALA with Candela V-beam Pulse Dye Laser
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring acne vulgaris, acne, dermatalogy

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Acne complete /incomplete therapy and reoccurence

Secondary Outcome Measures

Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)

Full Information

First Posted
December 23, 2008
Last Updated
December 2, 2014
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT00814918
Brief Title
Topical 5-ALA-PDT With Blu-U Therapy Versus Topical 5-ALA With Pulse Dye Laser In Treating Recalcitrant Acne Vulgaris
Official Title
Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne vulgaris, acne, dermatalogy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
5-ALA Application and exposure using Blu-U light to 1/2 of face.
Arm Title
2
Arm Type
Experimental
Arm Description
5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face.
Intervention Type
Drug
Intervention Name(s)
5-ALA with Blu-U Light
Intervention Description
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
Intervention Name(s)
5-ALA with Candela V-beam Pulse Dye Laser
Intervention Description
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).
Primary Outcome Measure Information:
Title
Acne complete /incomplete therapy and reoccurence
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
Time Frame
2-18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Tsoukas, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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