Photodynamic Therapy for Papulopustular Rosacea

Study Overview
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Brief Summary
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Rosacea is a chronic inflammatory disorder that is characterized by severe flushing (transient erythema), non-transient erythema, papules, pustules, and telangiectasia. Topical therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid recurrence is common following the use of systemic antibiotics, resulting in the chronic use of these medications to control the disease. Although the exact pathogenesis of rosacea is unknown, treatment for this condition has been investigated based on its similarity to acne and photodamaged skin. Case reports have shown promising results in rosacea patients treated with methyl aminolevulinate photodynamic therapy (MAL - PDT). Other than a case report which observed significant improvement of papules, pustules, erythema, and flushing following 5 - aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the role of ALA-PDT in the treatment of rosacea has not been reported. We have designed a pilot study investigating the efficacy of ALA-PDT in treating papulopustular rosacea. The objectives of the study are as follows: Primary objective: To evaluate improvement of the inflammatory lesions (papules, pustules, nodules), erythema, and telangiectasia of rosacea as assessed by the Investigator's Global Assessment (IGA). To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA). Secondary objectives: To evaluate improvement of rosacea associated erythema as assessed by the Clinical Erythema Assessment (CEA) scale. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as measured by a difference in inflammatory lesion count. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.

Official Title
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Photodynamic Therapy for Papulopustular Rosacea

Conditions
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Rosacea, Papulopustular Rosacea

Intervention / Treatment
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* Drug: Aminolevulinic acid topical solution 20%
* Device: Blu-U Light Therapy
* Other: Placebo vehicle only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-79 years Clinical diagnosis of papulopustular rosacea based on physician evaluation. Only patients with 3-50 papules and/or pustules, and a CEA total score ≥ 5, (See Section 4.1.3) will be enrolled. History of failing at least one conventional treatment for rosacea (metronidazole, sodium sulfacetamide, tetracycline, azelaic acid) or not interested in continuous treatment with these agents. Exclusion Criteria: < 18 or > 79 years of age Allergy to 5 - aminolevulinic acid (ALA) or any component of the vehicle Use of topical acne or rosacea treatments (on the face) within 2 weeks prior to Visit 1 Use of systemic antibiotics within 1 month prior to Visit 1 Use of topical retinoids (on the face) within 1 month prior to Visit 1 Use of systemic retinoids, including isotretinoin, within 6 months prior to Visit 1. Use of laser or light based rosacea treatments (on the face) within 1 month prior to Visit 1 Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within 2 months prior to Visit 1 Use of topical corticosteroids (on the face) 1 month prior to Visit 1 Use of systemic corticosteroids 3 months prior to Visit 1 Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview History of adverse reaction to light exposure History of disorder of porphyrin metabolism Scarring or infection in the area being treated Extensive facial hair that would either impair blue light exposure or interfere with lesion evaluation Inability to make study visits or anticipated poor compliance Pregnant females or nursing mothers. Eligible women of reproductive age will be required to have a negative urine pregnancy test at screening. They will also be required to be on at least one reliable form of effective birth control [examples: barrier method (condoms, diaphragm), oral, injectable, implant birth control or abstinence] during the course of this study and 30 days following the last treatment period. Life threatening illness that would interfere with the patient's ability to complete the study Participation in another clinical experimental therapeutic study within 30 days of screening visit Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator, unsuitable for the study.

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levulan and Blu-U Light<br>Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light | Drug: Aminolevulinic acid topical solution 20%<br>* Intervention used in the experimental arm only<br>* Other names: Levulan Kerastick;Device: Blu-U Light Therapy<br>* Intervention used in experimental and sham arms<br>|
| Sham Comparator: Vehicle and Blu-U Light<br>Entire face treated with vehicle substance only and Blu-U light | Device: Blu-U Light Therapy<br>* Intervention used in experimental and sham arms<br>|
| Placebo Comparator: Vehicle Only<br>Entire face treated with vehicle substance only | Other: Placebo vehicle only<br>* Intervention only includes the placebo vehicle solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA) | The Investigator's global assessment (IGA) of rosacea is a subjective 7-point, static scoring system. Scores range from 0 to 6: 0 (clear), 1 (minimal), 2 (mild), 3 (mild to moderate), 4 (moderate), 5 (moderate to severe), 6 (severe). | 17 weeks | 
| Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA) | The Inflammatory Lesion Investigator's Global Assessment (ILIGA) is a subjective 5-point measure of the overall disease severity. Scores range from 0 to 4: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe). | 17 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale | The Clinical Erythema Assessment (CEA) scale is an assessment of erythema. It has a score range from 0 to 4: 0 (none), 1 (mild), 2 (moderate), 3 (significant), 4 (severe). The total score is based on the evaluation of all areas of the face (forehead, chin, right cheek, left cheek, and nose). Each of these areas were scored from 0-4, giving a maximum total score of 20. | 17 weeks | 
| Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC) | The Inflammatory Lesion Count (ILC) is calculated by the number of inflammatory lesions (papules, pustules, nodules) as recorded by the investigator. | 17 weeks | 
| Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale | For the Patient Overall Assessments (POA) scale, patients assessed the overall improvement of their rosacea using a 4-point scale, where 1 = excellent improvement, 2 = good/moderate improvement, 3 = no change, 4 = worsening. | 17 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rosacea, Photodynamic Therapy, Aminolevulinic Acid, Papulopustular Rosacea, Blue Light