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NCT02075671 · ClinicalTrials.gov registry record · Phase 4
Photodynamic Therapy for Papulopustular Rosacea
A Phase 4 study, sponsored by George Washington University.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02075671 is a Phase 4 study that has completed, run by George Washington University. The registered enrollment target is 30 participants.
The verdict
NCT02075671, a Phase 4 study, has completed, sponsored by George Washington University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG Aminolevulinic acid topical solution 20%
- DEVICE Blu-U Light Therapy
- OTHER Placebo vehicle only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-04-24 |
| Est. Completion | 2019-08-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02075671
The ClinicalTrials.gov registry entry for NCT02075671 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Aminolevulinic acid topical solution 20% is the first listed.
NCT02075671 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02075671 about?
NCT02075671 is a clinical study titled "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 ...
What is the current status of trial NCT02075671?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2014-04-24. Estimated completion is 2019-08-15.
What interventions are being tested in trial NCT02075671?
The interventions under investigation include: Aminolevulinic acid topical solution 20% (DRUG), Blu-U Light Therapy (DEVICE), Placebo vehicle only (OTHER).
Who is sponsoring clinical trial NCT02075671?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
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