Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT03298581|
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : October 2, 2017
Last Update Posted : June 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: Halobetasol Propionate||Phase 2|
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. Patients must be overall in good health and should have a current diagnosis of moderate to severe plaque psoriasis with Investigator Global Assessment (IGA) score of at least 3 or 4. Patients will be stratified by age with:
Cohort 1: At least 20 patients 18 years of age and older with ≥ 20% body surface area (BSA) affected Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 10% BSA affected Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the study and a safety analysis has been reviewed by the Medical Monitor and approved by the Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort 1 has been reviewed and approved. Confirmation of email receipt will be required from each Investigator before enrollment of Cohort 2 can begin. Each cohort will be enrolled based on the availability of patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1 experience HPA axis suppression or 30% or more of the final enrolled number of patients in Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at any time, patients currently enrolled will be contacted via phone and instructed to discontinue study product immediately. Patients will be instructed to return for their next scheduled visit for cortisol response testing. Sites will follow up with patients and monitor for HPA axis suppression. All patients will be followed until cortisol levels are normal.
Patients will be instructed to apply topical spray twice daily onto the affected skin areas for 28 days. Patients will be instructed not to rub over the affected area after application of spray Patients will apply the morning dose of the study product in the clinic at each clinic visit and at home during non-clinic visits. A phone call will be made approximately 14 days after the patient has completed dosing to follow-up on any new adverse events that may have occurred
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label, single treatment arm study|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Safety Study to Assess the Multiple-dose Pharmacokinetics and Potential for Adrenal Suppression Following Topical Treatment With Halobetasol Propionate 0.05% Topical Spray Applied Twice Daily for 28 Days in Patients With Moderate to Severe Plaque Psoriasis|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
Experimental: Halobetasol propionate spray 0.05%
Patients will instructed o apply halobetasol spray twice daily for 14 days and not to rub over the affected area after application of spray.
Drug: Halobetasol Propionate
Experimental: Treatment with topical halobetasol spray 0.05% Patients will instructed o apply halobetasol spray twice daily for 28 days and not to rub over the affected area after application of spray.
Other Name: Topical treatment with Halobetasol spray
- Change from baseline in the IGA score at Day 28 [ Time Frame: 28 days ]Patients will be considered to have shown improvement in disease severity if the IGA score decreases by at least one unit from the baseline score, and will be considered a treatment success if the IGA score is either 0 (clear) or 1 (minimal).
- Hypothalamic Pituitary Adrenal (HPA) Axis suppression [ Time Frame: 28 days ]Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence, defined by 30 minute post- CortrosynTM injection level cortisol level of ≤18 mcg/100 mL, at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298581
|Study Director:||Rajinder k Jalali, MD||Sun Pharmaceutical Industries Limited|