Photodynamic Therapy for Papulopustular Rosacea

NCT ID: NCT02075671

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-24
• Study Completion Date: 2019-08-15

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.

Conditions

Rosacea; Papulopustular Rosacea

Keywords

Rosacea; Photodynamic Therapy; Aminolevulinic Acid; Papulopustular Rosacea; Blue Light

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Levulan and Blu-U Light

Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light

Group Type: EXPERIMENTAL

Aminolevulinic acid topical solution 20%

Intervention Type: DRUG

Intervention used in the experimental arm only

Blu-U Light Therapy

Intervention Type: DEVICE

Intervention used in experimental and sham arms

Vehicle and Blu-U Light

Entire face treated with vehicle substance only and Blu-U light

Group Type: SHAM_COMPARATOR

Blu-U Light Therapy

Intervention Type: DEVICE

Intervention used in experimental and sham arms

Vehicle Only

Entire face treated with vehicle substance only

Group Type: PLACEBO_COMPARATOR

Placebo vehicle only

Intervention Type: OTHER

Intervention only includes the placebo vehicle solution

Interventions

Aminolevulinic acid topical solution 20%

Intervention used in the experimental arm only

Intervention Type: DRUG

Blu-U Light Therapy

Intervention used in experimental and sham arms

Intervention Type: DEVICE

Placebo vehicle only

Intervention only includes the placebo vehicle solution

Intervention Type: OTHER

Other Intervention Names

Levulan Kerastick

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison Ehrlich, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

George Washington University Department of Dermatology

Kamaria Nelson, MD

Role: STUDY_DIRECTOR

George Washington University Department of Dermatology

Locations

Medical Faculty Associates - George Washington University

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

031416

Identifier Type: -

Identifier Source: org_study_id