Psoriasis VulgarisPhase 2NCT00593177
A Safety and Efficacy Study of a Topical Gel for the Treatment of Mild to Moderate Psoriasis
A Phase 2 study of Psoriasis Vulgaris, run by Manhattan Pharmaceuticals at 4 sites in United States.
Trial summary
The primary objective of the study is to assess the tolerability and efficacy of a 0.10% or 0.05% PTH (1-34) parathyroid hormone peptide gel in the treatment of mild to moderate plaque psoriasis in comparison to treatment with the placebo gel alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis Vulgaris
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2007to Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mentally competent and has completed an appropriately administered informed consent.
- Male or non-pregnant female outpatient between the ages of 18 to 65 years.
- If subject is a woman of childbearing potential, she must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline, and agree to use an effective, non-prohibited form of birth control for the duration of the study (stabilized on hormonal contraceptives for at least two months (e.g. oral, implant, injection, NuvaRing, patch), IUD, condom and spermicidal or diaphragm and spermicidal, abstinence, etc.).
- Willing and able to apply the assigned study medication as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Clinical diagnosis of stable plaque psoriasis for at least 3 months.
- Plaque psoriasis with a minimum of 2% affected BSA (excluding palms, soles, face, scalp, groin, axillae or other intertriginous areas).
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- Subject's disease is suitable to be managed topically for the duration of the trial.
- Subject has a Target Plaque that must have:
- a minimum of 16 cm2 in area
- an Overall Disease Severity Score of 2 or 3
- an induration score of 2 or 3
- Willing and able to avoid prolonged exposure of the designated treatment lesions to ultraviolet radiation (natural and artificial) for the duration of the study.
- In good general health and free of any disease state or physical condition which might impair evaluation of plaque psoriasis or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
Who cannot join
- Female who is lactating, or is planning to become pregnant during the study.
- Has spontaneously improving or rapidly deteriorating plaque psoriasis.- Has guttate, pustular, erythrodermic, inverse or other non-plaque forms of psoriasis.
- Has used any psoriasis vaccine or has participated in an investigational study of any psoriasis vaccine.
- Has used any systemic immunomodulatory therapy known to affect psoriasis that DOES typically decrease immune cell populations (e.g. alefacept) within the 36 weeks prior to start of treatment.- Subject has used any systemic immunomodulatory therapy known to affect psoriasis that DOES NOT typically decrease immune cell populations (e.g. efalizumab, etanercept, infliximab, adalimumab, and any investigational anti-TNF or anti-IL-12/23 agents) within 12 weeks prior to start of treatment.
- Has used any photo-therapy (including laser), photo-chemotherapy or systemic psoriasis therapy (e.g. systemic corticosteroids, methotrexate, retinoids or cyclosporine) within 4 weeks prior to start of treatment.
- Prolonged exposure to natural or artificial sources (e.g. UVB, UVA, etc.) of ultraviolet radiation within 4 weeks prior to the start of treatment or is intending to have such exposure during the study, thought by the investigator likely to modify the subject's psoriasis.
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- Has used topical anti-psoriatic therapy (including topical retinoids, corticosteroids, vitamin D derivatives, topical immunomodulators, coal tar or salicylic acid preparations) on the areas to be treated within 2 weeks prior to start of treatment.
- Has used emollients/moisturizers on areas to be treated within 2 days prior to the start of treatment.
- Has used lithium or hydroxychloroquine within 4 weeks prior to start of treatment.
- Currently using a beta-blocking medication (e.g. propranolol) with a dose that has not been stabilized for at least 3 months prior to the start of treatment.
- Has recently been on medications for osteoporosis including but not limited to bisphosphonates, calcitonin, teriparatide, androgen or other anabolic steroid therapy, fluorides, vitamin D >50,000 IU/week, within the past 6 months.
- May be unreliable including subjects who engage in excessive alcohol intake or drug abuse.- Subject has, in the opinion of the investigator, any clinically significant abnormalities in the clinical laboratory tests (serum chemistries, hematology or urinalysis) conducted at screening.- Subject has a history of hypercalcemia (consistent with elevated serum calciums above 10.5 mg/dl), illnesses that affect bone or calcium metabolism or recent nephrolithiasis or urolithiasis (within the previous 2 years).
- Has a history of radiation therapy involving the skeleton.
- Has a history of sensitivity to any of the ingredients in the study medications.
- Currently enrolled in an investigational drug or device study.
- Has used an investigational drug or an investigational device treatment within 30 days prior to start of treatment.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, 32174
Dermatology Research Center Inc.
Salt Lake City, Utah, 84124
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of 0.10% or 0.05% PTH (1-34) Gel Versus Placebo Gel in the Treatment of Mild to Moderate Plaque Psoriasis.
The primary objective of the study is to assess the tolerability and efficacy of a 0.10% or 0.05% PTH (1-34) parathyroid hormone peptide gel in the treatment of mild to moderate plaque psoriasis in comparison to treatment with the placebo gel alone.
Read the detailed description
This pilot study aims to confirm the results of a previous proof of concept study performed by Dr. Michael Holick using a different dosage form. The secondary objective is to determine if there is a dose dependent difference or trend in response between the two concentrations of PTH (1-34) peptide gel.
Subjects will be randomized to receive one of three treatment groups on a 1:1:1 basis. The three treatment groups are:
- Treatment Group 1: 0.05% PTH (1-34) Gel
- Treatment Group 2: 0.10% PTH (1-34) Gel
- Treatment Group 3: Placebo Gel
- Conditions
- Psoriasis Vulgaris
- Being tested
- PTH (1-34) Gel / Placebo Gel
- Keywords
- Plaque psoriasis, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTH (1-34) Gel / Placebo GelDrug
Topical dosing of gel twice daily for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | 0.05% PTH (1-34) Gel Receives: Drug: PTH (1-34) Gel / Placebo Gel |
| Treatment Group 2 | Experimental | 0.10% PTH (1-34) Gel Receives: Drug: PTH (1-34) Gel / Placebo Gel |
| Treatment Group 3 | Placebo comparator | Placebo (Vehicle) Gel Receives: Drug: PTH (1-34) Gel / Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
All efficacy variables graded will be evaluated. Individual parameters of psoriasis include Erythema (0-4 scale); Scaling (0-4 scale); Induration (0-4 scale); Pruritus (0-3 scale); and Overall Disease Severity Score (0-4 scale).
Measured: Weeks 1 to 8
Secondary outcomes (1)
As this is the early stage trial in psoriatic subjects using this novel topical therapy, no specific primary or secondary endpoints are designated.
Measured: Weeks 1 to 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Investigators
- Tatjana Lukic, M.D., M.Sc., Study chair, Manhattan Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593177
- Sponsor's protocol ID
- MAN-PTH (1-34)-USA-002
- Other IDs
- 095-3351-201
- Status last verified
- Jul 2008
- First submitted
- 2 Jan 2008
- Last updated
- 19 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Holick MF, Chimeh FN, Ray S. Topical PTH (1-34) is a novel, safe and effective treatment for psoriasis: a randomized self-controlled trial and an open trial. Br J Dermatol. 2003 Aug;149(2):370-6. doi: 10.1046/j.1365-2133.2003.05437.x.
PubMed 12932245
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of 0.10% or 0.05% PTH (1-34) Gel Versus Placebo Gel in the Treatment of Mild to Moderate Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT00593177
- Acronym / sponsor ID
- MAN-PTH (1-34)-USA-002
- Conditions
- Psoriasis Vulgaris
- Keywords
- Plaque psoriasis, Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Manhattan PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Jan 2008 (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.
The primary objective of the study is to assess the tolerability and efficacy of a 0.10% or 0.05% PTH (1-34) parathyroid hormone peptide gel in the treatment of mild to moderate plaque psoriasis in comparison to treatment with the placebo gel alone.
Detailed description
This pilot study aims to confirm the results of a previous proof of concept study performed by Dr. Michael Holick using a different dosage form. The secondary objective is to determine if there is a dose dependent difference or trend in response between the two concentrations of PTH (1-34) peptide gel.
Subjects will be randomized to receive one of three treatment groups on a 1:1:1 basis. The three treatment groups are:
- Treatment Group 1: 0.05% PTH (1-34) Gel
- Treatment Group 2: 0.10% PTH (1-34) Gel
- Treatment Group 3: Placebo Gel
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: PTH (1-34) Gel / Placebo Gel0.05% PTH (1-34) Gel |
| Treatment Group 2 | Experimental | Drug: PTH (1-34) Gel / Placebo Gel0.10% PTH (1-34) Gel |
| Treatment Group 3 | Placebo comparator | Drug: PTH (1-34) Gel / Placebo GelPlacebo (Vehicle) Gel |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Mentally competent and has completed an appropriately administered informed consent.
- Male or non-pregnant female outpatient between the ages of 18 to 65 years.
- If subject is a woman of childbearing potential, she must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline, and agree to use an effective, non-prohibited form of birth control for the duration of the study (stabilized on hormonal contraceptives for at least two months (e.g. oral, implant, injection, NuvaRing, patch), IUD, condom and spermicidal or diaphragm and spermicidal, abstinence, etc.).
- Willing and able to apply the assigned study medication as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- Clinical diagnosis of stable plaque psoriasis for at least 3 months.
Key exclusion criteria (16 listed)
- Female who is lactating, or is planning to become pregnant during the study.
- Has spontaneously improving or rapidly deteriorating plaque psoriasis.- Has guttate, pustular, erythrodermic, inverse or other non-plaque forms of psoriasis.
- Has used any psoriasis vaccine or has participated in an investigational study of any psoriasis vaccine.
- Has used any systemic immunomodulatory therapy known to affect psoriasis that DOES typically decrease immune cell populations (e.g. alefacept) within the 36 weeks prior to start of treatment.- Subject has used any systemic immunomodulatory therapy known to affect psoriasis that DOES NOT typically decrease immune cell populations (e.g. efalizumab, etanercept, infliximab, adalimumab, and any investigational anti-TNF or anti-IL-12/23 agents) within 12 weeks prior to start of treatment.
- Has used any photo-therapy (including laser), photo-chemotherapy or systemic psoriasis therapy (e.g. systemic corticosteroids, methotrexate, retinoids or cyclosporine) within 4 weeks prior to start of 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 |
|---|---|---|
| PTH (1-34) Gel / Placebo GelTopical dosing of gel twice daily for eight weeks. | Drug | Treatment Group 1, Treatment Group 2, Treatment Group 3 |
Primary outcome
All efficacy variables graded will be evaluated. Individual parameters of psoriasis include Erythema (0-4 scale); Scaling (0-4 scale); Induration (0-4 scale); Pruritus (0-3 scale); and Overall Disease Severity Score (0-4 scale).
Time frame: Weeks 1 to 8
1 secondary outcome
As this is the early stage trial in psoriatic subjects using this novel topical therapy, no specific primary or secondary endpoints are designated.
Time frame: Weeks 1 to 8
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 19 Aug 2008.
- Background: PubMed 12932245Holick MF, Chimeh FN, Ray S. Topical PTH (1-34) is a novel, safe and effective treatment for psoriasis: a randomized self-controlled trial and an open trial. Br J Dermatol. 2003 Aug;149(2):370-6. doi: 10.1046/j.1365-2133.2003.05437.x.
- AbstractLink provided by the sponsor.
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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.
Tatjana Lukic, M.D., M.Sc. study chair
Manhattan Pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Psoriasis Vulgaris, run by Manhattan Pharmaceuticals at 4 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 13 inclusion and 16 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 19 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 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?
All efficacy variables graded will be evaluated. Individual parameters of psoriasis include Erythema (0-4 scale); Scaling (0-4 scale); Induration (0-4 scale); Pruritus (0-3 scale); and Overall Disease Severity Score (0-4 scale). (time frame: Weeks 1 to 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00593177, which also lists 1 linked publication.
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 19 Aug 2008.