safety, pharmacokinetics and efficacy of arq-151 cream in adults with mild to moderate chronic plaque psoriasis

Conditions: Psoriasis

Summary: this study assessed the safety and pharmacokinetics (pk) of a single dose application of arq-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s) (cohort 1). the study also assessed the safety, pk and efficacy of arq-151 cream 0.5% vs vehicle and arq-151 cream 0.15% vs vehicle applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (bsa) of chronic plaque psoriasis (cohort 2).

there were 2 cohorts of participants. cohort 1 was a single dose study of arq-151 0.5% cream applied to 25 cm\^2 of psoriatic plaque(s) in 8 psoriasis participants. cohort 2 was a parallel group, double blind, vehicle controlled study in which arq-151 cream 0.5%, arq-151 cream 0.15% or vehicle cream was applied once a day for 28 days to participants with between 0.5% to 5.0% bsa of chronic plaque psoriasis. participants were adult (≥18 years old) males or females with chronic plaque psoriasis.

Eligibility criteria:
inclusion criteria: * adult male and female participants aged ≥18 years. * in cohort 1, participants must have at least 25 cm\^2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles). * in cohort 2, participants must have 0.5% to 5.0% of total bsa of chronic plaque psoriasis and at least one target plaque, of at least 9 cm\^2 in size with a tpss ≥4 (excluding the face, scalp, intertriginous areas, palms and soles). * women of childbearing potential must have a negative urine pregnancy test at screening and agree to use birth control throughout the trial. * in good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ecg), serum chemistry labs, hematology values, and urinalysis. * participants agree not to have prolonged sun exposure during the course of the study. tanning bed use is not allowed. * participants are competent to sign and give informed consent and considered reliable and capable of adhering to the protocol and visit schedule. exclusion criteria: * participants with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis. * evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication. * pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication. * known allergies to excipients in arq-151 cream. * participants who cannot discontinue the use of strong p-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period. * participants who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study. * participants who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis. * participants with a history of chronic alcohol or drug abuse in past 6 months. * history of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (pde-4) inhibitors. * current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix. * participants with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents. * participants who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.

Keywords: psoriasis plaque psoriasis