Back to resultsClobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clobetasol propionate 0.05% Topical Oil
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects in good general health confirmed by medical history.
- Subjects with a clinical diagnosis of AD (according to the criteria of Hanifin and Rajka) of moderate to severe intensity (ISGA score of 3 or 4) involving ≥25% to ≤50% of total BSA located within treatable areas (Cohort 1), or ≥35% to ≤50% of total BSA located within treatable areas (Cohorts 2 and 3), with treatable areas including all but the face, axillae, groin, and scalp.
- Subjects with a normally functioning HPA axis, defined as a prestimulation serum cortisol level >5 µg/100 mL, and a response to cosyntropin stimulation to >18 µg/100 mL (after approximately 30 minutes); both blood draws for this test should be performed in the morning, if possible
- Female subjects of childbearing potential must have a negative urine pregnancy test, must not be breastfeeding, and must agree to use an acceptable form of birth control for the duration of the study. Female subjects of childbearing potential are defined as all female subjects who have reached menarche and are not two years postmenopausal or who have reached menarche and have not had a hysterectomy, bilateral tubal ligation, and/or complete bilateral oophorectomy
Exclusion Criteria:
- Subjects who do not have a normally functioning HPA axis (as defined in the inclusion criteria).
- Subjects with an abnormal sleep schedule or who work at night.
- Subjects who have used topical dermal corticosteroids or topical immunomodulators (e.g., tacrolimus or pimecrolimus) within 3 weeks before Day 1, and subjects who are using any systemic medication known to affect cortisol levels or HPA axis integrity, systemic corticosteroids, an acute systemic course of corticosteroids, and/or any biological medication within 30 days before Day 1.
- Subjects with concomitant medical or dermatologic disorders (neurodermatitis, skin atrophy, striae, telangiectasia, etc.) that may interfere with study objectives and/or evaluations.
- Subjects with active skin infection.
- Subjects with any known significant endocrinological disorder that may require prohibited treatment, any known underlying disease that the investigator deems uncontrolled and poses a safety risk for the subject while participating in the study, known sensitivity to any ingredient of the study preparation, or a history of adverse responses to topical or systemic steroid therapy.
- Subjects who are pregnant or nursing.
- Subjects who have used bleach baths, phototherapy, and/or tanning beds, and/or who have had excessive sun exposure within 1 week before Day 1 and/or are planning to use any of these during the study.
- Subjects who have participated in a clinical drug or device research study and/or used any investigational treatment within the last 30 days before Day
Sites / Locations
- International Clinical Research - US, LLC
- AeroAllergy Research Laboratories of Savannah, Inc
- Paddington Testing Co., Inc.
- Spartanburg Medical Research
- Progressive Clinical Research
- Clinical Research Partners, LLC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
clobetasol propionate topical oil
Arm Description
clobetasol propionate 0.05% topical oil applied as thin film twice daily for 2 weeks
Outcomes
Primary Outcome Measures
Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test)
30-minute Post-stimulation cortisol level ≤18 µg/100 mL at Day 0 means subject is not enrolled; 30-minute Post-stimulation cortisol level ≤18 µg/100 mL at end of treatment (Day 15) means subject had suppression.
Adverse Events, Including Treatment Emergent Adverse Events (TEAEs)
number of events and percentage of subjects with AEs including TEAEs
Secondary Outcome Measures
Full Information
NCT ID
NCT03847389
First Posted
January 23, 2019
Last Updated
June 1, 2021
Sponsor
Hill Dermaceuticals, Inc.
Collaborators
Synteract, Inc., Covance
1. Study Identification
Unique Protocol Identification Number
NCT03847389
Brief Title
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Official Title
Open-Label Study of the Pharmacokinetics and Safety Including HPA Axis Suppression Potential of Clobetasol Topical Oil in Pediatric Subjects With Moderate to Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in enrollment and COVID-19 pandemic.
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
May 2, 2020 (Actual)
Study Completion Date
July 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill Dermaceuticals, Inc.
Collaborators
Synteract, Inc., Covance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with moderate to severe atopic dermatitis (AD) under maximal use conditions.
The study duration for each subject will be up to 54 days (up to 38 days for Screening assessments, followed by up to 16 days of treatment and follow-up). Additional time will be required for subjects requiring additional hypothalamic-pituitary-adrenal [HPA] axis function testing due to an abnormal result at End of Treatment.
Detailed Description
This study is a multicenter, open-label study designed to evaluate the HPA axis suppression potential and systemic exposure to clobetasol, when administered as Clobetasol Topical Oil in pediatric subjects, under conditions consistent with anticipated clinical use and under conditions designed to maximize the potential for drug absorption in subjects with moderate to severe AD. The study will consist of three successively younger pediatric cohorts, as safety data allow:
Cohort 1: ≥12 to <18 years;
Cohort 2: ≥6 to <12 years; and
Cohort 3: ≥2 to <6 years. Enrollment into each successively younger pediatric cohort will proceed only after the preceding cohort has been completed and safety and exploratory data (including adverse events [AEs], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) have been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 will proceed only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, is ≤40%. HPA axis suppression is defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open-label, maximal use, in 3 successive age cohorts
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clobetasol propionate topical oil
Arm Type
Other
Arm Description
clobetasol propionate 0.05% topical oil applied as thin film twice daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Clobetasol propionate 0.05% Topical Oil
Other Intervention Name(s)
clobetasol propionate topical solution
Intervention Description
thin film application of the oil twice daily
Primary Outcome Measure Information:
Title
Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test)
Description
30-minute Post-stimulation cortisol level ≤18 µg/100 mL at Day 0 means subject is not enrolled; 30-minute Post-stimulation cortisol level ≤18 µg/100 mL at end of treatment (Day 15) means subject had suppression.
Time Frame
day 0 and day 15.
Title
Adverse Events, Including Treatment Emergent Adverse Events (TEAEs)
Description
number of events and percentage of subjects with AEs including TEAEs
Time Frame
Days 0, 1, 8 and 15
Other Pre-specified Outcome Measures:
Title
ISGA Category
Description
ISGA results will be summarized at each visit as:
number and percentage of subjects in each ISGA category
number and percentage of subjects with an ISGA score of either 0 or 1 (clear or almost clear)
number and percentage of subjects with an ISGA improvement of at least 2 grades from Baseline to each post-baseline evaluation
number and percentage of subjects with an ISGA score of either 0 or 1 (clear or almost clear) and an improvement of at least 2 grades from Baseline to each post-Baseline evaluation
Time Frame
Days 0, 1, 8 and 15 Efficacy assessment, including ISGA, was not performed due to premature termination of the study.
Title
Assessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters).
Description
The subject will rate the sensation of burning/stinging within the past 24 hours as none (0), mild (1), moderate (2) or severe (3), and the Investigator will assess skin atrophy, striae, folliculitis, and telangiectasias, as absent (0) or present (1).
Time Frame
Days 1, 8 and 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects in good general health confirmed by medical history.
Subjects with a clinical diagnosis of AD (according to the criteria of Hanifin and Rajka) of moderate to severe intensity (ISGA score of 3 or 4) involving ≥25% to ≤50% of total BSA located within treatable areas (Cohort 1), or ≥35% to ≤50% of total BSA located within treatable areas (Cohorts 2 and 3), with treatable areas including all but the face, axillae, groin, and scalp.
Subjects with a normally functioning HPA axis, defined as a prestimulation serum cortisol level >5 µg/100 mL, and a response to cosyntropin stimulation to >18 µg/100 mL (after approximately 30 minutes); both blood draws for this test should be performed in the morning, if possible
Female subjects of childbearing potential must have a negative urine pregnancy test, must not be breastfeeding, and must agree to use an acceptable form of birth control for the duration of the study. Female subjects of childbearing potential are defined as all female subjects who have reached menarche and are not two years postmenopausal or who have reached menarche and have not had a hysterectomy, bilateral tubal ligation, and/or complete bilateral oophorectomy
Exclusion Criteria:
Subjects who do not have a normally functioning HPA axis (as defined in the inclusion criteria).
Subjects with an abnormal sleep schedule or who work at night.
Subjects who have used topical dermal corticosteroids or topical immunomodulators (e.g., tacrolimus or pimecrolimus) within 3 weeks before Day 1, and subjects who are using any systemic medication known to affect cortisol levels or HPA axis integrity, systemic corticosteroids, an acute systemic course of corticosteroids, and/or any biological medication within 30 days before Day 1.
Subjects with concomitant medical or dermatologic disorders (neurodermatitis, skin atrophy, striae, telangiectasia, etc.) that may interfere with study objectives and/or evaluations.
Subjects with active skin infection.
Subjects with any known significant endocrinological disorder that may require prohibited treatment, any known underlying disease that the investigator deems uncontrolled and poses a safety risk for the subject while participating in the study, known sensitivity to any ingredient of the study preparation, or a history of adverse responses to topical or systemic steroid therapy.
Subjects who are pregnant or nursing.
Subjects who have used bleach baths, phototherapy, and/or tanning beds, and/or who have had excessive sun exposure within 1 week before Day 1 and/or are planning to use any of these during the study.
Subjects who have participated in a clinical drug or device research study and/or used any investigational treatment within the last 30 days before Day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosario G Ramirez, MD
Organizational Affiliation
Hill Dermaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
International Clinical Research - US, LLC
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
AeroAllergy Research Laboratories of Savannah, Inc
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Paddington Testing Co., Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
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