Clinical trial NCT02075671: Photodynamic Therapy for Papulopustular Rosacea
Official title: Photodynamic Therapy for Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Papulopustular Rosacea
Keywords: Rosacea
Photodynamic Therapy
Aminolevulinic Acid
Papulopustular Rosacea
Blue Light
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: DUSA Pharmaceuticals, Inc.
First posted: 2014-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)
timeFrame: 17 weeks
measure: Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)
timeFrame: 17 weeks
Secondary outcomes:
measure: Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale
timeFrame: 17 weeks
measure: Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)
timeFrame: 17 weeks
measure: Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medical Faculty Associates - George Washington University
state: District of Columbia
Study officials:
affiliation: George Washington University Department of Dermatology
name: Alison Ehrlich, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University Department of Dermatology
name: Kamaria Nelson, MD
role: STUDY_DIRECTOR
References: