Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
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|ClinicalTrials.gov Identifier: NCT03212963|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: Halobetasol Topical Lotion||Phase 4|
This is an open label, multicenter study of an investigational formulation of HBP Lotion, 0.05% in male and female subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Approximately 25 subjects with stable plaque psoriasis on at least 10% of their BSA (excluding the face, scalp, groin, axillae and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites. All subjects will have a screening CST to assess their HPA axis response at Visit 1 (Screening Visit).
Enrollment into the treatment phase of the study should be timed such that the screening CST will be performed a minimum of 20 days before Baseline Visit. At Visit 2 (Baseline), eligible subjects with normal adrenal function will be eligible to participate in the study.
Subjects will apply HBP Lotion, 0.05% to all psoriasis plaques identified at Visit 2 twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verifies the subject's psoriasis has cleared. The study is designed to determine the adrenal suppression potential and pharmacokinetic properties of the test article after the subject applies a maximum of approximately 50 grams per week for up to a two week treatment period. All subjects will have a CST to reassess their HPA axis response at EOS (or earlier if the investigator verifies the subject's psoriasis has cleared). In this study, an abnormal Hypothalamujs Pituitary Adrenal axis response to 0.25 milligram dose of cosyntropin is defined as a post-CST serum total cortisol level of less than equal to18 μg/dL.
Eligible subjects will have blood drawn at Screening for baseline drug concentration in plasma. On Day 8, all subjects, regardless of lesion clearance, will have blood drawn for assessment of trough drug concentration in plasma. At the Day 15 visit, subjects who have continued to treat lesions will have a final PK blood sample collected approximately 12 hours after their Day 14 evening application and just prior to the initiation of the CST.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label study to evaluate adrenal suppression potential and pharmacokinetics of halobetasol lotion 0.05%|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Lotion, 0.05% in Subjects 12 to 16 Years 11 Months of Age With Plaque Psoriasis Receiving Two Weeks of Treatment|
|Actual Study Start Date :||March 21, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Halobetasol lotion treatment arm
All subjects will receive Halobetasol Topical Lotion, 0.05%.
Drug: Halobetasol Topical Lotion
Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Other Name: Halobetasol topical lotion 0.05%
- Hypothalamus pituitary adrenal axis suppression [ Time Frame: 2 weeks ]HPA axis responses to stimulation by cosyntropin will be dichotomized to "normal" and "abnormal". An abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤18 μg/dL at the end of study.
- Safety endpoint assessed by Adverse events [ Time Frame: 2 weeks ]Adverse events
- Plasma Levels of halobetasol lotion [ Time Frame: Day 8 and Day 15 ]Trough HBP concentrations in plasma will be assessed at Screening, Day 8 and Day 15/EOS approximately 12 hour posttreatment.
- Safety Endpoint assessed by Local Skin Reactions [ Time Frame: 2 weeks ]Local Skin Reactions
- Extent of exposure to halobetasol lotion 0.05% [ Time Frame: 2 weeks ]The total amount of test article applied (grams) will be calculated from the weights of the returned test articles. Mean, median, standard deviation, minimum and maximum will be determined for the total amount of test article used by each subject.
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): NCT03212963
|Contact: Syed Qadryemail@example.com|
|United States, Florida|
|Olympian Clinical Research||Recruiting|
|Clearwater, Florida, United States, 33756|
|Contact: Matthew Brent Zook, MD, PhD 813-849-5566|
|Contact: Dustin SIegert 813-849-5566 firstname.lastname@example.org|
|Wisdom Clinical Research Institute, Corp.||Recruiting|
|Coral Gables, Florida, United States, 33134|
|Contact: Maria Carballosa, MD 305-443-3480|
|Contact: Dalila Diaz 305-443-3480 email@example.com|
|ASCLEPES Research Center||Recruiting|
|Spring Hill, Florida, United States, 34609|
|Contact: Imad Jandali, MD firstname.lastname@example.org|
|Contact: Katie Leonard 352-364-9427 email@example.com|
|Study Chair:||Stephanie Magajna, MS||Therapeutics, Inc.|