Photodynamic Therapy for Papulopustular Rosacea

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.

Study Overview

• Status: Completed
• Conditions: Rosacea; Papulopustular Rosacea
• Intervention / Treatment: Drug: Aminolevulinic acid topical solution 20%; Device: Blu-U Light Therapy; Other: Placebo vehicle only

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Medical Faculty Associates - George Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages 18-79 years
2. 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.
3. 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:

1. < 18 or > 79 years of age
2. Allergy to 5 - aminolevulinic acid (ALA) or any component of the vehicle
3. Use of topical acne or rosacea treatments (on the face) within 2 weeks prior to Visit 1
4. Use of systemic antibiotics within 1 month prior to Visit 1
5. Use of topical retinoids (on the face) within 1 month prior to Visit 1
6. Use of systemic retinoids, including isotretinoin, within 6 months prior to Visit 1.
7. Use of laser or light based rosacea treatments (on the face) within 1 month prior to Visit 1
8. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within 2 months prior to Visit 1
9. Use of topical corticosteroids (on the face) 1 month prior to Visit 1
10. Use of systemic corticosteroids 3 months prior to Visit 1
11. Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview
12. History of adverse reaction to light exposure
13. History of disorder of porphyrin metabolism
14. Scarring or infection in the area being treated
15. Extensive facial hair that would either impair blue light exposure or interfere with lesion evaluation
16. Inability to make study visits or anticipated poor compliance
17. 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.
18. Life threatening illness that would interfere with the patient's ability to complete the study
19. Participation in another clinical experimental therapeutic study within 30 days of screening visit
20. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: DUSA Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Alison Ehrlich, MD, MHS, George Washington University Department of Dermatology; Study Director: Kamaria Nelson, MD, George Washington University Department of Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2014
• Primary Completion (Actual): August 15, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rosacea; Photodynamic Therapy; Aminolevulinic Acid; Papulopustular Rosacea; Blue Light
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 031416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No