Photodynamic Therapy for Papulopustular Rosacea

NCT02075671 | Completed Phase 4 Results

• 1 other identifier: 031416
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 2.To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA).
3. 3.To evaluate improvement of rosacea associated erythema as assessed by the Clinical Erythema Assessment (CEA) scale.
4. 4.To evaluate improvement of the inflammatory lesions (papules, pustules, nodules) of rosacea as measured by a difference in inflammatory lesion count.
5. 5.To evaluate improvement of rosacea as assessed by the Patient Overall Assessment Scale.

Conditions

Rosacea; Papulopustular Rosacea

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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).

  17 weeks

• 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).

  17 weeks

Secondary Outcomes (3)

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

  17 weeks

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

  17 weeks

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

  17 weeks

Study Arms (3)

Levulan and Blu-U Light

EXPERIMENTAL

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

Drug: Aminolevulinic acid topical solution 20%; Device: Blu-U Light Therapy

Vehicle and Blu-U Light

SHAM COMPARATOR

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

Device: Blu-U Light Therapy

Vehicle Only

PLACEBO COMPARATOR

Entire face treated with vehicle substance only

Other: Placebo vehicle only

Interventions

Aminolevulinic acid topical solution 20% DRUG

Intervention used in the experimental arm only

Also known as: Levulan Kerastick

Levulan and Blu-U Light

Blu-U Light Therapy DEVICE

Intervention used in experimental and sham arms

Levulan and Blu-U Light; Vehicle and Blu-U Light

Placebo vehicle only OTHER

Intervention only includes the placebo vehicle solution

Vehicle Only

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• George Washington University: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Medical Faculty Associates - George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dermatology Research Fellow
• Organization: The George Washington University, Medical Faculty Associates

knelson@mfa.gwu.edu

202-741-2632

Study Officials

• Alison Ehrlich, MD, MHS

  George Washington University Department of Dermatology

  PRINCIPAL INVESTIGATOR

• Kamaria Nelson, MD

  George Washington University Department of Dermatology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: April 24, 2014
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: December 29, 2022
• Results First Posted: December 29, 2022

Record last verified: 2022-12

Locations

US (1)