Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis

NCT03298581 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 71542610
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the IGA score at Day 28

  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).

  28 days

Secondary Outcomes (1)

• Hypothalamic Pituitary Adrenal (HPA) Axis suppression

  28 days

Study Arms (1)

Halobetasol propionate spray 0.05%

EXPERIMENTAL

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

Interventions

Halobetasol Propionate DRUG

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.

Also known as: Topical treatment with Halobetasol spray

Halobetasol propionate spray 0.05%

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or non-pregnant, non-lactating females:
• Cohort 1: 18 years of age and older
• Cohort 2: 12-16 years and 11 months of age (Cohort 2 will not begin enrollment until review and approval of safety information from Cohort 1.)
• 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:
• Cohort 1: 18 years of age and older with ≥ 20% BSA affected (excluding the face, scalp, groin, axillae and other intertriginous areas)
• Cohort 2: 12-16 years and 11 months of age with ≥ 10% BSA affected (excluding the face, scalp, groin, axillae and other intertriginous areas)
• 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:
• Basal (pre-Cortrosyn™ injection) cortisol concentration ≥ 5 mcg/100 mL.
• minute post-injection cortisol level is at least 7 mcg/100 mL greater than the basal level (≥ basal value + 7).
• Post-stimulation level \> 18 mcg/100 mL.

You may not qualify if:

• 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.
• Lacks stable diagnosis of plaque psoriasis or has been diagnosed with mild plaque psoriasis.
• IGA score \< 3.
• Plaque psoriasis with a BSA involvement \< 20% for Cohort 1 or \< 10% for Cohort 2.
• Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfolative or pustular psoriasis).
• Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response:
• Basal (pre-CortrosynTM injection) cortisol concentration \< 5 mcg/100 mL.
• minute post-injection cortisol level is less than 7 mcg/100 mL greater than the basal level (\< basal value + 7).
• Post-stimulation level ≤ 18 mcg/100 mL.
• Patient has a history of plaque psoriasis that has been unresponsive to topical corticosteroid therapy.
• Any condition (i.e., sunburn, atopic or contact dermatitis, etc.) that, in the Investigator's opinion, may interfere with the clinical assessments of the signs and symptoms of plaque psoriasis.
• History of prolonged bleeding or a past diagnosis of bleeding disorders and/or history of blood loss exceeding 450 mL (including blood donations) within 1 month before the study.
• Patient with poor peripheral venous access.
• History of mastectomy or lymphatic insufficiency of the upper limb (patient is eligible if blood can be taken from the arm opposite the site of surgery or condition).
• History of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead
• Novum Pharmaceutical Research Services: collaborator

MeSH Terms

Interventions

halobetasol; Therapeutics

Study Officials

• Rajinder k Jalali, MD

  Sun Pharmaceutical Industries Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single treatment arm study

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 2, 2017
• Study Start: January 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: June 14, 2021

Record last verified: 2021-06