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
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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:
- To evaluate improvement of the inflammatory lesions (papules, pustules, nodules), erythema, and telangiectasia of rosacea as assessed by the Investigator's Global Assessment (IGA).
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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:
- To evaluate improvement of rosacea associated erythema as assessed by the Clinical Erythema Assessment (CEA) scale.
- To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as measured by a difference in inflammatory lesion count.
- To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.
Condition or disease | Intervention/treatment | Phase |
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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 : | February 2019 |
Estimated Study Completion Date : | February 2019 |

Arm | Intervention/treatment |
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Experimental: Levulan and Blu-U Light
Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light
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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
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Device: Blu-U Light Therapy
Intervention used in experimental and sham arms |
Placebo Comparator: Vehicle Only
Entire face treated with vehicle substance only
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Other: Placebo vehicle only
Intervention only includes the placebo vehicle solution |
- 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 ]
- 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 ]

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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 |
Inclusion Criteria:
- Ages 18-79 years
- 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.
- 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:
- < 18 or > 79 years of age
- Allergy to 5 - aminolevulinic acid (ALA) or any component of the vehicle
- Use of topical acne or rosacea treatments (on the face) within 2 weeks prior to Visit 1
- Use of systemic antibiotics within 1 month prior to Visit 1
- Use of topical retinoids (on the face) within 1 month prior to Visit 1
- Use of systemic retinoids, including isotretinoin, within 6 months prior to Visit 1.
- Use of laser or light based rosacea treatments (on the face) within 1 month prior to Visit 1
- Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within 2 months prior to Visit 1
- Use of topical corticosteroids (on the face) 1 month prior to Visit 1
- Use of systemic corticosteroids 3 months prior to Visit 1
- Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview
- History of adverse reaction to light exposure
- History of disorder of porphyrin metabolism
- Scarring or infection in the area being treated
- Extensive facial hair that would either impair blue light exposure or interfere with lesion evaluation
- Inability to make study visits or anticipated poor compliance
- 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.
- Life threatening illness that would interfere with the patient's ability to complete the study
- Participation in another clinical experimental therapeutic study within 30 days of screening visit
- 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.

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
Contact: Kamaria Nelson, MD | 202-741-2632 | knelson@mfa.gwu.edu |
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 |
Principal Investigator: | Alison Ehrlich, MD, MHS | George Washington University Department of Dermatology | |
Study Director: | Kamaria Nelson, MD | George Washington University Department of Dermatology |
Responsible Party: | Alison Ehrlich, Professor and Chair, Department of Dermatology, George Washington University |
ClinicalTrials.gov Identifier: | NCT02075671 |
Other Study ID Numbers: |
031416 |
First Posted: | March 3, 2014 Key Record Dates |
Last Update Posted: | August 24, 2018 |
Last Verified: | August 2018 |
Rosacea Photodynamic Therapy Aminolevulinic Acid Papulopustular Rosacea Blue Light |
Rosacea Skin Diseases Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents |