NCT02075671

Photodynamic Therapy for Papulopustular Rosacea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Aminolevulinic acid topical solution 20%	Intervention used in the experimental arm only
DEVICE	Blu-U Light Therapy	Intervention used in experimental and sham arms
OTHER	Placebo vehicle only	Intervention only includes the placebo vehicle solution

Timeline

• Start date: 2014-04-24
• Primary completion: 2019-08-15
• Completion: 2019-08-15
• First posted: 2014-03-03
• Last updated: 2022-12-29
• Results posted: 2022-12-29

Locations

1 site across 1 country: United States