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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: Completed Phase 4 study, sponsored by George Washington University.
NCT02075671 is a Phase 4 study that has completed, run by George Washington University. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
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 |
What the finished NCT02075671 record still lists
NCT02075671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Aminolevulinic acid topical solution 20% is the first listed.
NCT02075671 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02075671's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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