Clinical trial NCT00593177 (phase 2, status: completed)
Conditions: psoriasis vulgaris
ICD codes: L40.0
Drugs: pth (1-34) gel / placebo gel
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  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).

          -  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.

        Exclusion Criteria:

          -  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.

          -  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.