Photodynamic Therapy for Papulopustular Rosacea

Rosacea Clinical Trial

Official title:

Photodynamic Therapy for Papulopustular Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075671
• Other study ID #: 031416
• Status: Completed
• Phase: Phase 4
• Start date: April 24, 2014
• Est. completion date: August 15, 2019

Study information

• Verified date: December 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Aminolevulinic acid topical solution 20%
Intervention used in the experimental arm only

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

Other:
• Placebo vehicle only
Intervention only includes the placebo vehicle solution

Locations

Country	Name	City	State
United States	Medical Faculty Associates - George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	DUSA Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	17 weeks
Secondary	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.	17 weeks
Secondary	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.	17 weeks