Last updated: 11/04/2018 10:23:28
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to investigate the irritation potential on healthy intact skin and effect on psoriatic skin of topical applications of GW786034
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Up to 8 weeks
Secondary outcomes:
Laser doppler imaging,epidermal thickness by histology skin biopsies Primary pharmacokinetic endpoints AUC(0-t) and Cmax of GW786034 in plasma following repeat dosing
Timeframe: Up to 8 weeks
Interventions:
Drug: Pazopanib
Drug: Pazopanib vehicle
Drug: Betamethasone valerate
Drug: Calcipotriol
Enrollment:
10
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Psoriasis
Product
pazopanib
Collaborators
Not applicable
Study date(s)
September 2005 to February 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- 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.
- Guttate, erythrodermic, or pustular psoriasis.
- Psoriasis is spontaneously improving.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- 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 location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-24-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study RES104031 can be found on the GSK Clinical Study Register.
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