PsoriasisPhase 1NCT00358384
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
A Phase 1 study testing Pazopanib, Betamethasone valerate and Calcipotriol in people with Psoriasis, run by GlaxoSmithKline at 1 site in France.
Trial summary
This study is an exploratory study to evaluate the effectiveness, safety and tolerability of three concentrations of GW786034 ointment following treatment to small areas of stable psoriatic plaques. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Pazopanib, Betamethasone valerate and Calcipotriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2005to 24 Feb 2006
- Phase
- Phase 1
- 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
- Stable (2-3 months) chronic plaque psoriasis covering greater than 5% body surface area (as determined by PASI palm method).
- Other than having chronic plaque psoriasis, subject is health and ambulatory.
- Women will be eligible to enter the study if they are of non-child-bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile).
- Must have at least two clinically similar lesions with the following characteristics as deemed by the dermatologist: Moderate to severe in elevation (thickness), erythema, and scaling (with a total score of at least 6 for each target lesion, when assessed using a 0-4 PASI score). Located on the trunk, buttocks, thighs or upper arms. Are of a sufficient size that will allow the application of three occlusive patches.
Who cannot join
- Guttate, erythrodermic, or pustular psoriasis.
- Psoriasis is spontaneously improving.
- Have had psoriasis that was unresponsive to adequately dosed (> 10 weeks) cyclosporine.
- Any systemic disorder or active skin disease (other than psoriasis) or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area.
- History of congestive heart failure (NYHA Class 3 or 4), myocardial infarction, coronary artery bypass graft, percutaneous transluminal balloon angioplasty, cerebrovascular accident, chronic or intermittent oedema.
- Blood pressure of greater than 150mmHg systolic and /or 95mmHg diastolic following triplicate measurements taken 5 minutes apart.
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- Presence of unstable or severe angina or coronary insufficiency.
- Uncontrolled bacterial, viral, or fungal infection.
- Congenital or acquired immunodeficiency.
- History of malignancy within the last five years, except for surgically cured skin carcinoma or cervical dysplasia (CIN I-II).
- An unwillingness of male subjects to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant from the time of the first dose of study medication until 5 half-lives of the drug have elapsed following removal of the last dose of study medication.
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of first dose of study medication until five half-lives or 5 days (whichever is longer) following removal of the last dose of study medication.
- Prolonged exposure to the sun (or tanning beds) during the study.
- Systemic anti-psoriasis therapy, including but not limited to: acitretin, cyclosporine, isotretinoin, infliximab, entercept, alefacept, oral steroids and psoralen during the 4 weeks prior to the first dose of study medication and throughout the study.
- Concomitant use of phototherapy or photochemotherapy.
- Concomitant use of lithium, antimalarials, interferons.
- Systemic beta-blockers are permitted provided the dose is stable for four weeks before baseline and remains stable throughout the study.
- Concomitant use of anti-arthritis therapies with known propensity for hepatotoxicity (i.e. diclofenac, gold, D-penicillamine, leflunomide).
- Use of topical or intralesional treatments for psoriasis (e.g. mid- or high-potency topical corticosteroids) within 2 weeks prior to Day 1 and throughout the study, except for class VI or VII topical steroid treatments (Desonide, or 2.5% hydrocortisone) which will be allowed on the face.
- Concomitant use of non-drug therapies (i.e. herbal products or alternative therapies) for psoriasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Irritation Potential on Healthy Intact Skin and Effect on Psoriatic Skin of Topical Applications of GW786034
This study is an exploratory study to evaluate the effectiveness, safety and tolerability of three concentrations of GW786034 ointment following treatment to small areas of stable psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of ointment will be applied under full occlusion to representative psoriatic plaques. The effectiveness of topical GW786034 treatments and controls will be explored using visual intensity assessments in addition to dermal imaging and histological surrogates of disease activity.
- Conditions
- Psoriasis
- Being tested
- Pazopanib, Pazopanib vehicle, Betamethasone valerate, Calcipotriol
- Keywords
- tolerability, safety, angiogenesis, vascular endothelial growth factor, pharmacodynamics, pharmacokinetics, microplaque, VEGF, GW786034
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Pazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent.
Pazopanib vehicleDrug
Pazopanib vehicle will be given to subjects.
Betamethasone valerateDrug
Betamethasone valerate ointment with 0.1 percent concentration will be given to subjects.
CalcipotriolDrug
Calcipotriol ointment with 0.005 percent concentration will be given to subjects.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment A | Experimental | Eligible subjects will receive 0.1 percent pazopanib ointment. Receives: Drug: Pazopanib |
| Subjects receiving treatment B | Experimental | Eligible subjects will receive 0.5 percent pazopanib ointment. Receives: Drug: Pazopanib |
| Subjects receiving treatment C | Experimental | Eligible subjects will receive 1 percent pazopanib ointment. Receives: Drug: Pazopanib |
| Subjects receiving treatment D | Placebo comparator | Eligible subjects will receive pazopanib vehicle as negative control. Receives: Drug: Pazopanib vehicle |
| Subjects receiving treatment E | Placebo comparator | Eligible subjects will receive 0.1 percent betamethasone valerate ointment as steroid positive control. Receives: Drug: Betamethasone valerate |
| Subjects receiving treatment F | Placebo comparator | Eligible subjects will receive 0.005 percent calcipotriol ointment as vitamin D agonist positive control. Receives: Drug: Calcipotriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual assessment and clinical scoring of lesion treatment areas using modified Psoriasis Area Scoring Index (PASI) target lesion assessment scale Clinical lab tests vital signs adverse events clinical monitoring/observation
Measured: Up to 8 weeks
Secondary outcomes (1)
Laser doppler imaging,epidermal thickness by histology skin biopsies Primary pharmacokinetic endpoints AUC(0-t) and Cmax of GW786034 in plasma following repeat dosing
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2006 (estimated)
- Study start26 Sep 2005
- Primary completion24 Feb 2006
- Study completion24 Feb 2006
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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358384
- Sponsor's protocol ID
- RES104031
- Status last verified
- Nov 2017
- First submitted
- 27 Jul 2006
- Last updated
- 13 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Irritation Potential on Healthy Intact Skin and Effect on Psoriatic Skin of Topical Applications of GW786034
- ClinicalTrials.gov ID
- NCT00358384
- Acronym / sponsor ID
- RES104031
- Conditions
- Psoriasis
- Keywords
- tolerability, safety, angiogenesis, vascular endothelial growth factor, pharmacodynamics, pharmacokinetics, microplaque, VEGF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2005 (actual)
- Primary completion
- 24 Feb 2006 (actual)
- Study completion
- 24 Feb 2006 (actual)
- First posted
- 31 Jul 2006 (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 study is an exploratory study to evaluate the effectiveness, safety and tolerability of three concentrations of GW786034 ointment following treatment to small areas of stable psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of ointment will be applied under full occlusion to representative psoriatic plaques. The effectiveness of topical GW786034 treatments and controls will be explored using visual intensity assessments in addition to dermal imaging and histological surrogates of disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment A | Experimental | Drug: PazopanibEligible subjects will receive 0.1 percent pazopanib ointment. |
| Subjects receiving treatment B | Experimental | Drug: PazopanibEligible subjects will receive 0.5 percent pazopanib ointment. |
| Subjects receiving treatment C | Experimental | Drug: PazopanibEligible subjects will receive 1 percent pazopanib ointment. |
| Subjects receiving treatment D | Placebo comparator | Drug: Pazopanib vehicleEligible subjects will receive pazopanib vehicle as negative control. |
| Subjects receiving treatment E | Placebo comparator | Drug: Betamethasone valerateEligible subjects will receive 0.1 percent betamethasone valerate ointment as steroid positive control. |
| Subjects receiving treatment F | Placebo comparator | Drug: CalcipotriolEligible subjects will receive 0.005 percent calcipotriol ointment as vitamin D agonist positive control. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable (2-3 months) chronic plaque psoriasis covering greater than 5% body surface area (as determined by PASI palm method).
- Other than having chronic plaque psoriasis, subject is health and ambulatory.
- Women will be eligible to enter the study if they are of non-child-bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile).
- Must have at least two clinically similar lesions with the following characteristics as deemed by the dermatologist: Moderate to severe in elevation (thickness), erythema, and scaling (with a total score of at least 6 for each target lesion, when assessed using a 0-4 PASI score). Located on the trunk, buttocks, thighs or upper arms. Are of a sufficient size that will allow the application of three occlusive patches.
Key exclusion criteria (20 listed)
- Guttate, erythrodermic, or pustular psoriasis.
- Psoriasis is spontaneously improving.
- Have had psoriasis that was unresponsive to adequately dosed (> 10 weeks) cyclosporine.
- Any systemic disorder or active skin disease (other than psoriasis) or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area.
- History of congestive heart failure (NYHA Class 3 or 4), myocardial infarction, coronary artery bypass graft, percutaneous transluminal balloon angioplasty, cerebrovascular accident, chronic or intermittent oedema.
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 |
|---|---|---|
| PazopanibPazopanib will be available in dosing strengths of 0.1, 0.5 and 1 percent. | Drug | Subjects receiving treatment A, Subjects receiving treatment B, Subjects receiving treatment C |
| Pazopanib vehiclePazopanib vehicle will be given to subjects. | Drug | Subjects receiving treatment D |
| Betamethasone valerateBetamethasone valerate ointment with 0.1 percent concentration will be given to subjects. | Drug | Subjects receiving treatment E |
| CalcipotriolCalcipotriol ointment with 0.005 percent concentration will be given to subjects. | Drug | Subjects receiving treatment F |
Primary outcome
Visual assessment and clinical scoring of lesion treatment areas using modified Psoriasis Area Scoring Index (PASI) target lesion assessment scale Clinical lab tests vital signs adverse events clinical monitoring/observation
Time frame: Up to 8 weeks
1 secondary outcome
Laser doppler imaging,epidermal thickness by histology skin biopsies Primary pharmacokinetic endpoints AUC(0-t) and Cmax of GW786034 in plasma following repeat dosing
Time frame: Up to 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 13 Nov 2017.
- Results for study RES104031 can be found on the GSK Clinical Study Register.Link 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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pazopanib, Betamethasone valerate and Calcipotriol in people with Psoriasis, run by GlaxoSmithKline at 1 site in France.
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 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 13 Nov 2017. 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 France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Visual assessment and clinical scoring of lesion treatment areas using modified Psoriasis Area Scoring Index (PASI) target lesion assessment scale Clinical lab tests vital signs adverse events clinical monitoring/observation (time frame: Up to 8 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 13 Nov 2017.