PsoriasisPhase 2NCT00941278
An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis
A Phase 2 study testing PH-10 (0.001% Rose Bengal) in people with Psoriasis, run by Provectus Pharmaceuticals at 2 sites in United States.
Trial summary
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- PH-10 (0.001% Rose Bengal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to Apr 2010
- 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
- Men or women, age 18 or older.
- Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
- Fitzpatrick skin type I-VI.
- Written informed consent by the subject or legal guardian.
Who cannot join
- Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
- Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
- Subjects who have received UVB light therapy within 14 days of study initiation.
- Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
- Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
- Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
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- Subjects who have participated in a clinical research study within 28 days of study initiation.
- Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- Subjects with clinical conditions that, in the opinion of the 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
2 sites in 1 country.
United States2 sites
International Dermatology Research
Miami, Florida, 33144
Mount Sinai School of Medicine
New York, New York, 10029
About this study
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
- Conditions
- Psoriasis
- Being tested
- PH-10 (0.001% Rose Bengal)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH-10 (0.001% Rose Bengal)Drug
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
| Study group | Role | What they receive |
|---|---|---|
| PH-10 Treatment | Experimental | Not described Receives: Drug: PH-10 (0.001% Rose Bengal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
Measured: 28 days
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Measured: 8 weeks
Secondary outcomes (3)
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Measured: 8 weeks
Plaque Response score changes at each visit from Day 1 pre-treatment.
Measured: 8 weeks
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Provectus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Wachter, PhD, Study director, Provectus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941278
- Sponsor's protocol ID
- PH-10-PS-22
- Status last verified
- Jul 2010
- First submitted
- 15 Jul 2009
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00941278
- Acronym / sponsor ID
- PH-10-PS-22
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Provectus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 17 Jul 2009 (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.
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PH-10 Treatment | Experimental | Drug: PH-10 (0.001% Rose Bengal) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women, age 18 or older.
- Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
- Fitzpatrick skin type I-VI.
- Written informed consent by the subject or legal guardian.
Key exclusion criteria (9 listed)
- Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
- Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
- Subjects who have received UVB light therapy within 14 days of study initiation.
- Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
- Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
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 (0.001% Rose Bengal)PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis. | Drug | PH-10 Treatment |
Primary outcome
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
Time frame: 28 days
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Time frame: 8 weeks
3 secondary outcomes
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
Plaque Response score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Eric Wachter, PhD study director
Provectus Pharmaceuticals
2 sites 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 (0.001% Rose Bengal) in people with Psoriasis, run by Provectus Pharmaceuticals at 2 sites 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 4 inclusion and 9 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 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale. (time frame: 28 days). 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 7 Jul 2010.