Photodynamic Therapy for Papulopustular Rosacea

Phase 4

Completed

Conditions: Rosacea
Papulopustular Rosacea

Interventions: Drug: Aminolevulinic acid topical solution 20%
Other: Placebo vehicle only
Device: Blu-U Light Therapy

Registration Number: NCT02075671

Lead Sponsor: George Washington University

Brief Summary: 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:

1. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules), erythema, and telangiectasia of rosacea as assessed by the Investigator's Global Assessment (IGA).

2. 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:

3. To evaluate improvement of rosacea associated erythema as assessed by the Clinical Erythema Assessment (CEA) scale.

4. To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as measured by a difference in inflammatory lesion count.

5. To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levulan and Blu-U Light	Aminolevulinic acid topical solution 20%	Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Levulan and Blu-U Light	Blu-U Light Therapy	Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Vehicle and Blu-U Light	Blu-U Light Therapy	Entire face treated with vehicle substance only and Blu-U light
Vehicle Only	Placebo vehicle only	Entire face treated with vehicle substance only

Primary Outcome Measures

Name	Time	Method
Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)	17 weeks	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).
Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)	17 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)	17 weeks	The Inflammatory Lesion Count (ILC) is calculated by the number of inflammatory lesions (papules, pustules, nodules) as recorded by the investigator.
Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale	17 weeks	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.
Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale	17 weeks	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.