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Photodynamic Therapy for Papulopustular Rosacea

NCT02075671 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-29

Study results available
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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

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

Sponsors & Collaborators

  • DUSA Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • George Washington University

    lead OTHER

Principal Investigators

  • Alison Ehrlich, MD, MHS · George Washington University Department of Dermatology

  • Kamaria Nelson, MD · George Washington University Department of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-24
Primary Completion
2019-08-15
Completion
2019-08-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075671 on ClinicalTrials.gov