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

Study Overview
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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.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: 5-ALA with Blu-U Light
* Drug: 5-ALA with Candela V-beam Pulse Dye Laser


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>5-ALA Application and exposure using Blu-U light to 1/2 of face. | Drug: 5-ALA with Blu-U Light<br>* 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).<br>|
| Experimental: 2<br>5-ALA Application and exposure using Candela V-beam Pulse Dye Laser to 1/2 of face. | Drug: 5-ALA with Candela V-beam Pulse Dye Laser<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acne complete /incomplete therapy and reoccurence |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation) |  | 2-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, acne, dermatalogy