safety and efficacy of arq-154 foam in adolescent and adult subjects with scalp and body psoriasis

Conditions: Plaque Psoriasis

Summary: this study will assess the safety and efficacy of arq-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis

this is a parallel group, double blind, vehicle-controlled study in which arq-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis

Eligibility criteria:
inclusion criteria: * participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws. * males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents). * scalp psoriasis with an investigator global assessment of scalp disease severity (s-iga) of at least mild ('2') at baseline. * a psoriasis scalp severity index (pssi) score of at least 6 at baseline. * a pasi score of at least 2 (excluding the palms and soles) at baseline. * clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the investigator. stable disease for the past 4 weeks. * females of childbearing potential (focbp) must have a negative serum pregnancy test at screening (visit 1) and a negative urine pregnancy test at baseline (visit 2). * females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. * subjects in good health as judged by the investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis. * subjects are considered reliable and capable of adhering to the protocol and visit schedule according to the investigator judgment. exclusion criteria: * subjects who cannot discontinue medications and treatments prior to the baseline visit and during the study according to excluded medications and treatments. * planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other led. * subjects currently taking lithium or antimalarial drugs. * planned initiation or changes to concomitant medication that could, in the opinion of the investigator, affect psoriasis vulgaris (e.g. beta blockers, ace inhibitors). * current diagnosis of non-plaque forms of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). current diagnosis of drug-induced psoriasis. * subjects with any condition on the treatment area which, in the opinion of the investigator, could confound efficacy measurements. * known allergies to excipients in arq-154. * subjects who cannot discontinue the use of strong p-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the baseline visit (visit 2) and during the study. * subjects who cannot discontinue the use of strong p-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the baseline visit (visit 2) and during the study. * subjects with phq-8 \>/= 10 or modified phq-a \>/= 10 at screening or baseline. * females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. * subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the investigator. * subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of the investigational product. * subjects with a history of a major surgery within 4 weeks prior to baseline (visit 2) or has a major surgery planned during the study. * subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the investigator's opinion, makes them unsuitable for clinical study participation. * current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. * subjects with active infection that required oral or intravenous administration of antibiotics, antifungal, or antiviral agents within 7 days of baseline/day 0. * subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.