Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Hal… (NCT03298581) | Clinical Trial Compass
WithdrawnPhase 2
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis
Stopped: Sponsor decision
0Started 2017-01-01
Plain-language summary
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis. At least 40 eligible patients with plaque psoriasis that satisfy all eligibility criteria will be enrolled into the study
Who can participate
Age range12 Years – 70 Years
SexALL
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Inclusion criteria
✓. Males or non-pregnant, non-lactating females:
✓. If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
✓. Signed informed consent form that meets all criteria of current FDA regulations. For a patient considered to be a minor in the state he/she lives and is enrolled, the parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form. Approved informed consent and assent forms specific to each cohort will be required.
✓. Patients with a definite clinical diagnosis of stable plaque psoriasis with:
✓. Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe).
✓. Patients in Cohort 2 must weigh a minimum of 24 kg.
✓. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response. Patients must fulfill all of the following stipulations:
✕. Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of childbearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.