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Photodynamic Therapy for Papulopustular Rosacea

Primary Purpose

Rosacea, Papulopustular Rosacea

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aminolevulinic acid topical solution 20%

Blu-U Light Therapy

Placebo vehicle only

About this trial

This is an interventional treatment trial for Rosacea focused on measuring Rosacea, Photodynamic Therapy, Aminolevulinic Acid, Papulopustular Rosacea, Blue Light

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Medical Faculty Associates - George Washington University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Placebo Comparator

Arm Label

Levulan and Blu-U Light

Vehicle and Blu-U Light

Vehicle Only

Arm Description

Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light

Entire face treated with vehicle substance only and Blu-U light

Entire face treated with vehicle substance only

Outcomes

Primary Outcome Measures

Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)

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).

Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)

The Inflammatory Lesion Investigator's Global Assessment (ILIGA) is a subjective 5-point measure of the overall disease severity. Scores range from 0 to 4: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe).

Secondary Outcome Measures

Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale

The Clinical Erythema Assessment (CEA) scale is an assessment of erythema. It has a score range from 0 to 4: 0 (none), 1 (mild), 2 (moderate), 3 (significant), 4 (severe). The total score is based on the evaluation of all areas of the face (forehead, chin, right cheek, left cheek, and nose). Each of these areas were scored from 0-4, giving a maximum total score of 20.

Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)

The Inflammatory Lesion Count (ILC) is calculated by the number of inflammatory lesions (papules, pustules, nodules) as recorded by the investigator.

Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale

For the Patient Overall Assessments (POA) scale, patients assessed the overall improvement of their rosacea using a 4-point scale, where 1 = excellent improvement, 2 = good/moderate improvement, 3 = no change, 4 = worsening.

Full Information

NCT ID

NCT02075671

First Posted

February 27, 2014

Last Updated

December 1, 2022

Sponsor

George Washington University

Collaborators

DUSA Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02075671

Brief Title

Photodynamic Therapy for Papulopustular Rosacea

Official Title

Photodynamic Therapy for Papulopustular Rosacea

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

April 24, 2014 (Actual)

Primary Completion Date

August 15, 2019 (Actual)

Study Completion Date

August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

George Washington University

Collaborators

DUSA Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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: To evaluate improvement of the inflammatory lesions (papules, pustules, nodules), erythema, and telangiectasia of rosacea as assessed by the Investigator's Global Assessment (IGA). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea, Papulopustular Rosacea

Keywords

Rosacea, Photodynamic Therapy, Aminolevulinic Acid, Papulopustular Rosacea, Blue Light

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levulan and Blu-U Light

Arm Type

Experimental

Arm Description

Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light

Arm Title

Vehicle and Blu-U Light

Arm Type

Sham Comparator

Arm Description

Entire face treated with vehicle substance only and Blu-U light

Arm Title

Vehicle Only

Arm Type

Placebo Comparator

Arm Description

Entire face treated with vehicle substance only

Intervention Type

Drug

Intervention Name(s)

Aminolevulinic acid topical solution 20%

Other Intervention Name(s)

Levulan Kerastick

Intervention Description

Intervention used in the experimental arm only

Intervention Type

Device

Intervention Name(s)

Blu-U Light Therapy

Intervention Description

Intervention used in experimental and sham arms

Intervention Type

Other

Intervention Name(s)

Placebo vehicle only

Intervention Description

Intervention only includes the placebo vehicle solution

Primary Outcome Measure Information:

Title

Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)

Description

Time Frame

17 weeks

Title

Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)

Description

Time Frame

17 weeks

Secondary Outcome Measure Information:

Title

Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale

Description

Time Frame

17 weeks

Title

Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)

Description

The Inflammatory Lesion Count (ILC) is calculated by the number of inflammatory lesions (papules, pustules, nodules) as recorded by the investigator.

Time Frame

17 weeks

Title

Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale

Description

Time Frame

17 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison Ehrlich, MD, MHS

Organizational Affiliation

George Washington University Department of Dermatology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kamaria Nelson, MD

Organizational Affiliation

George Washington University Department of Dermatology

Official's Role

Study Director

Facility Information:

Facility Name

Medical Faculty Associates - George Washington University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy for Papulopustular Rosacea

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