A Phase 4 (Phase 2 in European Union), Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis

Prior treatment

• Is currently using lithium or Plaquenil
• Is unable to be compliant with study procedures, study drug administration requirements, study visit schedules, and prohibitions regarding the use of concomitant medications/therapies
• Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator
• Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline, or is concurrently participating in another clinical study with an investigational drug or device.
• Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit, and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.
• Has used any phototherapy (including laser), photochemotherapy, or systemic non-biologic psoriasis therapy (such as newer oral psoriasis medications [eg, Otezla], methotrexate, retinoids or cyclosporine) within 4 weeks prior to the Baseline visit, or systemic corticosteroids within 28 days prior to the screening HPA axis stimulation test.
• Has used immunomodulatory therapy (e.g., biologics) known to affect psoriasis within 3 months of baseline.
• Has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 4 weeks prior to screening or is intending to have exposure during the study thought likely by the investigator to modify the subject’s psoriasis

Other illness

• Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
• Has any underlying disease deemed uncontrolled by the investigator that poses a concern for the subject’s safety while participating in the study.
• Has a history of drug or alcohol abuse as determined by the investigator.
• Has a history of an adverse reaction to cosyntropin injection or similar test reagents
• Has a history of adrenal disease

Other

• Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator
• Is unable to communicate or cooperate with the investigator.
• Is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
• Has an abnormal sleep schedule or works at night.
• Is pregnant, nursing an infant, or planning a pregnancy during the study period

• Male or female, of any race, 6 to 16 years 11 months of age at the time of informed consent/assent obtained.
• Subject is willing to comply with study instructions and return to the clinic for required visits.
• Verbal and written informed consent/assent obtained from the subject and/or parent or legal guardian
• Has a clinical diagnosis of psoriasis at the Screening and Baseline visit with an Investigator’s Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.
• Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation
• Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study
• Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is > 18 μg/dL at screening.
• Is in good general health based on the subject’s medical history and a physical examination, with screening hematology and serum chemistry laboratory values within normal ranges or not clinically significant, as determined by the investigator
• Pre-menses females (9 and older) and females of childbearing potential, must have a negative urine and serum pregnancy test at Screening and a negative urine pregnancy test at the Baseline visit prior to study drug application.
• Females of childbearing potential and females who are pre-menses (9 and older) must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.). Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study