Plaque PsoriasisPhase 2NCT00555646
Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for Psoriasis
A Phase 2 study testing PH-10 (rose bengal disodium 0.001%) in people with Plaque Psoriasis, run by Provectus Pharmaceuticals at 1 site in United States.
Trial summary
This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- PH-10 (rose bengal disodium 0.001%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable, moderate to severe plaque psoriasis in at least three distinct plaque areas, each separated by at least a 2.5-cm band of normal skin. Study plaque areas, each covering a contiguous area up to 15 x 35 cm in size, should have a minimum plaque size of 2 cm2. All study plaque areas must be on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous sites).
- Fitzpatrick skin type I-VI.
- Ability to understand and sign the informed consent document.
Who cannot join
- Female subjects of childbearing potential who are pregnant, attempting to conceive, or nursing an infant.
- Subjects who have received PUVA or UVB light therapy or systemic antipsoriatic therapy within 4 weeks of study treatment (two weeks for methotrexate).
- Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin, or Vitamin D analogs) to the study plaque areas within 2 weeks of study treatment.
- Subjects who have received any photosensitizing or phototoxic drug within 4 weeks of study treatment.
- Subjects who have received any approved biologic drug therapy for psoriasis within 3 months or 5 half-lives of study treatment.
- Subjects who have participated in a clinical research study within 4 weeks of study treatment.
- Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- Subjects with clinical conditions that, in the opinion of the Principal Investigator, may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis
This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control.
Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control.
Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.
- Conditions
- Plaque Psoriasis
- Being tested
- PH-10 (rose bengal disodium 0.001%), Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH-10 (rose bengal disodium 0.001%)Drug
Treatment plaque area 1: PH-10 with 544 nm LED light illumination.
PH-10 (rose bengal disodium 0.001%)Drug
Treatment plaque area 2: PH-10 with ambient light illumination.
ControlDrug
No treatment control.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Each subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area. Receives: Drug: PH-10 (rose bengal disodium 0.001%); Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.
Treatment Success was assessed after 12 weeks and defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.
Measured: 12 weeks
Secondary outcomes (4)
Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4.
Pruritus was assessed on a scale ranging from 0 (no pruritus) to 4 (frequent, troublesome pruritus that interferes with sleep or other activities).
Measured: 12 weeks
Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area.
Measured: 12 weeks
Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response.
Measured: 16 weeks
Adverse Experience.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Change of dose regimen (new protocol)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provectus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Larian, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555646
- Sponsor's protocol ID
- PH-10-PS-21
- Status last verified
- Dec 2021
- First submitted
- 7 Nov 2007
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Topical PH-10 Aqueous Hydrogel and Photodynamic Therapy for the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00555646
- Acronym / sponsor ID
- PH-10-PS-21
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of dose regimen (new protocol)
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Provectus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 9 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, single center, controlled study with each subject's two treatment plaque areas assigned by the investigator 1:1 to (a) PH-10 with ambient light exposure and (b) PH-10 with 544 nm LED light illumination at 10 J/cm2. A third plaque area will receive no treatment and serve as a control.
Subjects with at least three distinct, stable study plaque areas will receive the experimental therapy to two treatment plaque areas twice a week (2-5 days apart) for the lesser of 12 weeks or until remission is observed in the treatment plaque areas. If remission is observed in a treatment plaque area then treatment of that area will be discontinued and the area assessed weekly. A third plaque area (control plaque area) will receive no drug or light treatment and serve as an internal control.
Primary efficacy will be assessed 12 weeks after initial PH-10 treatment. Subjects will be followed for a total of 16 weeks to allow assessment of Durability of Response of treated lesions and comprehensive follow-up of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PH-10 (rose bengal disodium 0.001%), Drug: ControlEach subject's study plaque areas will be assigned by the investigator to two PH-10 treatment plaque areas and one control plaque area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable, moderate to severe plaque psoriasis in at least three distinct plaque areas, each separated by at least a 2.5-cm band of normal skin. Study plaque areas, each covering a contiguous area up to 15 x 35 cm in size, should have a minimum plaque size of 2 cm2. All study plaque areas must be on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous sites).
- Fitzpatrick skin type I-VI.
- Ability to understand and sign the informed consent document.
Key exclusion criteria (8 listed)
- Female subjects of childbearing potential who are pregnant, attempting to conceive, or nursing an infant.
- Subjects who have received PUVA or UVB light therapy or systemic antipsoriatic therapy within 4 weeks of study treatment (two weeks for methotrexate).
- Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin, or Vitamin D analogs) to the study plaque areas within 2 weeks of study treatment.
- Subjects who have received any photosensitizing or phototoxic drug within 4 weeks of study treatment.
- Subjects who have received any approved biologic drug therapy for psoriasis within 3 months or 5 half-lives of study treatment.
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 |
|---|---|---|
| PH-10 (rose bengal disodium 0.001%)Treatment plaque area 1: PH-10 with 544 nm LED light illumination. | Drug | 1 |
| PH-10 (rose bengal disodium 0.001%)Treatment plaque area 2: PH-10 with ambient light illumination. | Drug | 1 |
| ControlNo treatment control. | Drug | 1 |
Primary outcome
Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.
Time frame: 12 weeks
Treatment Success was assessed after 12 weeks and defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale.
4 secondary outcomes
Change in Pruritus of subject's treatment and control plaque areas using a self-assessment scale of 0-4.
Time frame: 12 weeks
Time to Remission (TTR) based on the (a) number of treatments and (b) days elapsed until Treatment Success is noted in each treatment plaque area.
Time frame: 12 weeks
Durability of Response based on plaque areas exhibiting Treatment Success that retain this level of response.
Time frame: 16 weeks
Adverse Experience.
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Change of dose regimen (new protocol)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
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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.
Amir Larian, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH-10 (rose bengal disodium 0.001%) in people with Plaque Psoriasis, run by Provectus Pharmaceuticals 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 8 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: stopped early, as of the sponsor's last update on 16 Dec 2021. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Change of dose regimen (new protocol)). Results are not available in the source record.
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?
Treatment Success, defined as 0 or 1 on all Psoriasis Severity Index components (erythema, induration, and scaling) and 0 or 1 on the Plaque Response scale. (time frame: 12 weeks). 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 16 Dec 2021.