RosaceaPhase 4NCT02075671
Photodynamic Therapy for Papulopustular Rosacea
A Phase 4 study testing Aminolevulinic acid topical solution 20% and Blu-U Light Therapy in people with Rosacea and Papulopustular Rosacea, run by George Washington University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea, Papulopustular Rosacea
- What is being tested?
- Aminolevulinic acid topical solution 20% and Blu-U Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2014to 15 Aug 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- < 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Faculty Associates - George Washington University
Washington D.C., District of Columbia, 20037
About this study
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:
Read more
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.
- Conditions
- Rosacea, Papulopustular Rosacea
- Being tested
- Aminolevulinic acid topical solution 20%, Blu-U Light Therapy, Placebo vehicle only
- Keywords
- Rosacea, Photodynamic Therapy, Aminolevulinic Acid, Papulopustular Rosacea, Blue Light
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminolevulinic acid topical solution 20%Drug
Also called Levulan Kerastick
Intervention used in the experimental arm only
Blu-U Light TherapyDevice
Intervention used in experimental and sham arms
Placebo vehicle onlyOther
Intervention only includes the placebo vehicle solution
| Study group | Role | What they receive |
|---|---|---|
| Levulan and Blu-U Light | Experimental | Entire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light Receives: 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 Receives: Device: Blu-U Light Therapy |
| Vehicle Only | Placebo comparator | Entire face treated with vehicle substance only Receives: Other: Placebo vehicle only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 17 weeks
Secondary outcomes (3)
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.
Measured: 17 weeks
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.
Measured: 17 weeks
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.
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start24 Apr 2014
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Alison Ehrlich, MD, MHS, Principal investigator, George Washington University Department of DermatologyKamaria Nelson, MD, Study director, George Washington University Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075671
- Sponsor's protocol ID
- 031416
- Status last verified
- Dec 2022
- First submitted
- 27 Feb 2014
- Last updated
- 29 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy for Papulopustular Rosacea
- ClinicalTrials.gov ID
- NCT02075671
- Acronym / sponsor ID
- 031416
- Conditions
- Rosacea, Papulopustular Rosacea
- Keywords
- Rosacea, Photodynamic Therapy, Aminolevulinic Acid, Papulopustular Rosacea, Blue Light
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- DUSA Pharmaceuticals, Inc.
- Study start
- 24 Apr 2014 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 29 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levulan and Blu-U Light | Experimental | Drug: Aminolevulinic acid topical solution 20%, Device: Blu-U Light TherapyEntire face treated with 20% Aminolevulinic Acid (Levulan) and Blu-U light |
| Vehicle and Blu-U Light | Sham comparator | Device: Blu-U Light TherapyEntire face treated with vehicle substance only and Blu-U light |
| Vehicle Only | Placebo comparator | Other: Placebo vehicle onlyEntire face treated with vehicle substance only |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminolevulinic acid topical solution 20%Also: Levulan KerastickIntervention used in the experimental arm only | Drug | Levulan and Blu-U Light |
| Blu-U Light TherapyIntervention used in experimental and sham arms | Device | Levulan and Blu-U Light, Vehicle and Blu-U Light |
| Placebo vehicle onlyIntervention only includes the placebo vehicle solution | Other | Vehicle Only |
Primary outcome
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
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)
Time frame: 17 weeks
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).
3 secondary outcomes
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 (ILC)
Time frame: 17 weeks
Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale
Time frame: 17 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Ehrlich, MD, MHS principal investigator
George Washington University Department of Dermatology
Kamaria Nelson, MD study director
George Washington University Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aminolevulinic acid topical solution 20% and Blu-U Light Therapy in people with Rosacea and Papulopustular Rosacea, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.