Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03245385|
Recruitment Status : Terminated (Sponsors decision)
First Posted : August 10, 2017
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Treatment with Halobetasol propionate 0.05% topical spray||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 atopic dermatitis. At least 40 eligible patients with atopic dermatitis 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 atopic dermatitis 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 ≥ 25% BSA affected.
Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% 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. 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, as defined in study protocol. Patients enrolled in the study will apply the study product twice daily onto the affected skin areas for 14 days (Days 1-14), according to provided instructions. .Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses of study product. All patients will attend the clinic for the following 8 scheduled visits. Patients will apply the morning dose of the study product in the clinic at each clinic visit (and evening dose on Day 4) 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. All patients will have a cortisol response test performed at screening and on Day 17 (at least 48 hours after last dose of study product).
The safety profile of the test product will be evaluated by analysis of reported adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 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 (Sun Pharmaceuticals Industries Limited) in Patients With Moderate to Severe Atopic Dermatitis|
|Actual Study Start Date :||July 24, 2017|
|Actual Primary Completion Date :||February 5, 2018|
|Actual Study Completion Date :||February 5, 2018|
Experimental: Treatment with topical halobetasol 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: Treatment with Halobetasol propionate 0.05% topical spray
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
- Change from baseline in the IGA score at Days 4, 5, 7 and 14. [ Time Frame: 14 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 (almost clear).
- Hypothalamic Pituitary Adrenal (HPA) Axis suppression [ Time Frame: 14 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): NCT03245385
|United States, California|
|Providence Clinical Research|
|North Hollywood, California, United States, 91606|
|Havana Research Institute|
|Pasadena, California, United States, 91105|
|United States, Florida|
|Vital Pharma Research|
|Hialeah, Florida, United States, 33016|
|Solutions Through Advanced Research|
|Jacksonville, Florida, United States, 32256|
|Integrity Research Center|
|Miami, Florida, United States, 33015|
|Millennium Clinical Research, INC|
|Miami, Florida, United States, 33125|
|Regenerate Clinical Trials, LLC|
|Miami, Florida, United States, 33155|
|Life Medical Center and Research, INC|
|Miami, Florida, United States, 33166|
|Vista Health Research|
|Miami, Florida, United States, 33176|
|United States, Michigan|
|Troy, Michigan, United States, 48085|
|United States, Montana|
|Montana Medical Research/Elias Research Assoc.|
|Missoula, Montana, United States, 49808|
|United States, Pennsylvania|
|L&C Professional Medical Research Institute|
|Hazleton, Pennsylvania, United States, 18201|
|United States, Texas|
|Sun Research Institute|
|San Antonio, Texas, United States, 78215|
|Study Director:||Rajinder K Jalali, MD||Sun Pharmaceutical Industries Limited|