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

NCT03245385 | Terminated Phase 2 FDA Drug

• 1 other identifier: 71542613
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 13

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 atopic dermatitis. At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria will be enrolled into the study

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the IGA score at Days 4, 5, 7 and 14.

  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 (almost clear).

  14 days

Secondary Outcomes (1)

• Hypothalamic Pituitary Adrenal (HPA) Axis suppression

  14 days

Study Arms (1)

Treatment with topical halobetasol 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: Treatment with Halobetasol propionate 0.05% topical spray

Interventions

Treatment with Halobetasol propionate 0.05% topical spray DRUG

Patients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g

Treatment with topical halobetasol 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 moderate to severe atopic dermatitis with ≥ 25% BSA affected (excluding 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 26 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.
• Mild atopic dermatitis.
• IGA score \< 3.
• Atopic dermatitis with a BSA involvement \< 25%.
• 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.
• Recurrent or active cutaneous bacterial or viral infection in any treatment area at baseline (i.e., clinically infected atopic dermatitis).
• Patient has a history of atopic dermatitis that has been unresponsive to topical corticosteroid therapy.
• Any condition (i.e., sunburn, psoriasis etc.) that, in the Investigator's opinion, may interfere with the clinical assessments of the signs and symptoms of atopic dermatitis.
• 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

Study Sites (13)

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Havana Research Institute

Pasadena, California, 91105, United States

Location

Vital Pharma Research

Hialeah, Florida, 33016, United States

Location

Solutions Through Advanced Research

Jacksonville, Florida, 32256, United States

Location

Integrity Research Center

Miami, Florida, 33015, United States

Location

Millennium Clinical Research, INC

Miami, Florida, 33125, United States

Location

Regenerate Clinical Trials, LLC

Miami, Florida, 33155, United States

Location

Life Medical Center and Research, INC

Miami, Florida, 33166, United States

Location

Vista Health Research

Miami, Florida, 33176, United States

Location

Elias Research

Troy, Michigan, 48085, United States

Location

Montana Medical Research/Elias Research Assoc.

Missoula, Montana, 49808, United States

Location

L&C Professional Medical Research Institute

Hazleton, Pennsylvania, 18201, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Therapeutics; halobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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: August 5, 2017
• First Posted: August 10, 2017
• Study Start: July 24, 2017
• Primary Completion: February 5, 2018
• Study Completion: February 5, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (13)