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Photodynamic Therapy for Papulopustular Rosacea

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ClinicalTrials.gov Identifier: NCT02075671
Recruitment Status : Unknown
Verified August 2018 by Alison Ehrlich, George Washington University.
Recruitment status was:  Recruiting
First Posted : March 3, 2014
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Alison Ehrlich, George Washington University

Tracking Information
First Submitted Date  ICMJE February 27, 2014
First Posted Date  ICMJE March 3, 2014
Last Update Posted Date August 24, 2018
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2014)
  • Evaluate improvement of rosacea associated erythema as assessed by the Clinical Erythema Assessment (CEA) scale [ Time Frame: 17 weeks ]
  • Evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as measured by a difference in inflammatory lesion count [ Time Frame: 17 weeks ]
  • Evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale [ Time Frame: 17 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy for Papulopustular Rosacea
Official Title  ICMJE Photodynamic Therapy for Papulopustular Rosacea
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rosacea
  • Papulopustular Rosacea
Intervention  ICMJE
  • 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
  • Other: Placebo vehicle only
    Intervention only includes the placebo vehicle solution
Study Arms  ICMJE
  • Experimental: Levulan and Blu-U Light
    Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
    Interventions:
    • Drug: Aminolevulinic acid topical solution 20%
    • Device: Blu-U Light Therapy
  • Sham Comparator: Vehicle and Blu-U Light
    Entire face treated with vehicle substance only and Blu-U light
    Intervention: Device: Blu-U Light Therapy
  • Placebo Comparator: Vehicle Only
    Entire face treated with vehicle substance only
    Intervention: Other: Placebo vehicle only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 27, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02075671
Other Study ID Numbers  ICMJE 031416
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alison Ehrlich, George Washington University
Study Sponsor  ICMJE Alison Ehrlich
Collaborators  ICMJE DUSA Pharmaceuticals, Inc.
Investigators  ICMJE
Principal Investigator: Alison Ehrlich, MD, MHS George Washington University Department of Dermatology
Study Director: Kamaria Nelson, MD George Washington University Department of Dermatology
PRS Account George Washington University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP