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Photodynamic Therapy for Papulopustular Rosacea

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ClinicalTrials.gov Identifier: NCT02075671
Recruitment Status : Recruiting
First Posted : March 3, 2014
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
George Washington University

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.

Condition or disease Intervention/treatment Phase
Rosacea Papulopustular Rosacea Drug: Aminolevulinic acid topical solution 20% Device: Blu-U Light Therapy Other: Placebo vehicle only Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy for Papulopustular Rosacea
Study Start Date : April 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Levulan and Blu-U Light
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
Drug: Aminolevulinic acid topical solution 20%
Intervention used in the experimental arm only
Other Name: Levulan Kerastick

Device: Blu-U Light Therapy
Intervention used in experimental and sham arms

Sham Comparator: Vehicle and Blu-U Light
Entire face treated with vehicle substance only and Blu-U light
Device: Blu-U Light Therapy
Intervention used in experimental and sham arms

Placebo Comparator: Vehicle Only
Entire face treated with vehicle substance only
Other: Placebo vehicle only
Intervention only includes the placebo vehicle solution




Primary Outcome Measures :
  1. Improvement of the inflammatory lesions (papules, pustules, nodules), erythema, and telangiectasia of rosacea as assessed by the Investigator's Global Assessment (IGA) [ Time Frame: 17 weeks ]
  2. Improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA) [ Time Frame: 17 weeks ]

Secondary Outcome Measures :
  1. Evaluate improvement of rosacea associated erythema as assessed by the Clinical Erythema Assessment (CEA) scale [ Time Frame: 17 weeks ]
  2. Evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as measured by a difference in inflammatory lesion count [ Time Frame: 17 weeks ]
  3. Evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale [ Time Frame: 17 weeks ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075671


Contacts
Contact: Monica Rengifo-pardo, MD 202-677-6160 mrengifopardo@mfa.gwu.edu
Contact: Olabola Awosika, MD 202-741-2632 oawosika@mfa.gwu.edu

Locations
United States, District of Columbia
Medical Faculty Associates - George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Monica Rengifopardo, MD    202-677-6160    mrengifopardo@mfa.gwu.edu   
Principal Investigator: Alison Ehrlich, MD, MHS         
Sponsors and Collaborators
George Washington University
DUSA Pharmaceuticals, Inc.
Investigators
Principal Investigator: Alison Ehrlich, MD, MHS George Washington University Department of Dermatology
Study Director: Olabola Awosika, MD George Washington University Department of Dermatology

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT02075671     History of Changes
Other Study ID Numbers: 031416
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2016

Keywords provided by George Washington University:
Rosacea
Photodynamic Therapy
Aminolevulinic Acid
Papulopustular Rosacea
Blue Light

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents