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Clobetasol Topical Oil for Children With Moderate to Severe 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03847389
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : December 6, 2019
Synteract, Inc.
Information provided by (Responsible Party):
Hill Dermaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Clobetasol propionate 0.05% Topical Oil Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, maximal use, in 3 successive age cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
clobetasol propionate topical oil
clobetasol propionate 0.05% topical oil applied as thin film twice daily for 2 weeks
Drug: Clobetasol propionate 0.05% Topical Oil
thin film application of the oil twice daily
Other Name: clobetasol propionate topical solution

Primary Outcome Measures :
  1. Serum Cortisol concentration (Cortrosyn stimulation test) [ Time Frame: day 0 and day 14. ]
    Measure of serum cortisol concentration in µg/100 mL prior to cortrosyn stimulation, and at 30 minutes post-stimulation.

  2. HPA axis suppression [ Time Frame: day 0 and day 14. ]
    HPA axis suppression assessment is the number and percentage of subjects with post-stimulation cortisol concentration ≤18 µg/100 mL

  3. Maximum observed plasma concentration (Cmax) [ Time Frame: 0, 1, 3 and 6 hours after 2 weeks use. ]
    recorded measure of the maximum clobetasol concentration in the plasma measured in ng/mL

  4. Time of maximum observed plasma concentration (Tmax) [ Time Frame: 0, 1, 3 and 6 hours after 2 weeks use ]
    recorded time (hours and minutes) of maximum clobetasol concentration in the plasma

  5. Area under the curve from time 0 to 6 hours [AUC(0-6)] [ Time Frame: 0, 1, 3 and 6 hours after 2 weeks use ]
    the area under plasma concentration versus time curve, including Confidence Interval using descriptive statistics

  6. Adverse Events, including treatment emergent adverse events (TEAEs) [ Time Frame: Days 0, 1, 8 and 15 ]
    number of events and percentage of subjects with AEs including TEAEs

Other Outcome Measures:
  1. ISGA category [ Time Frame: Days 0, 1, 8 and 15 ]

    ISGA results will be summarized at each visit as:

    1. number and percentage of subjects in each ISGA category
    2. number and percentage of subjects with an ISGA score of either 0 or 1 (clear or almost clear)
    3. number and percentage of subjects with an ISGA improvement of at least 2 grades from Baseline to each post-baseline evaluation
    4. 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

  2. Assessment of burning/stinging, skin atrophy, striae, folliculitis, and telangiectasias (Tolerability parameters). [ Time Frame: Days 1, 8 and 15 ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03847389

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Contact: Rosario G Ramirez, MD 407-323-1887
Contact: Elizabeth M Cantrill 407-323-1887

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United States, Florida
International Clinical Research - US, LLC Recruiting
Sanford, Florida, United States, 32771
Contact: Andrea N Ragan, CCRP    407-878-5830   
Contact: David Casteel    407-878-5830   
Principal Investigator: Rion J Forconi, MD         
Sub-Investigator: Gary W Snell, MD         
United States, Georgia
AeroAllergy Research Laboratories of Savannah, Inc Recruiting
Savannah, Georgia, United States, 31406
Contact: Susie Gault, RN    912-356-3619   
Contact: Servon Jackson, RRT    912-356-3619   
Principal Investigator: Brad H Goodman, MD         
Sub-Investigator: Bruce D Finkel, MD         
Sub-Investigator: Elizabeth A Bonin, PA-C         
United States, Maryland
Mount Washington Pediatric Hospial Active, not recruiting
Baltimore, Maryland, United States, 21209
United States, Pennsylvania
Paddington Testing Co., Inc. Recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Hirak B Routh, MBBS    215-563-7330   
Contact: Kazal R Routh, MBBS    215-563-7330   
Principal Investigator: Lawrence C Parish, MD         
Sub-Investigator: Jennifer L Parish, MD         
United States, South Carolina
Spartanburg Medical Research Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Nicole L Crockford, PA-C    864-583-1556   
Contact: Jodi Sanders    864-583-1556   
Principal Investigator: Charles M Fogarty, MD         
Sub-Investigator: Nicole L Crockford, PA         
United States, Texas
Progressive Clinical Research Recruiting
San Antonio, Texas, United States, 78213
Contact: Tamara Oranday    210-614-5557   
Principal Investigator: Mark S Lee, MD         
Sub-Investigator: Theresia L Lee, MD         
United States, Virginia
Clinical Research Partners, LLC Recruiting
Richmond, Virginia, United States, 23220
Contact: Nikisha Edwards, MA    804-477-3045   
Contact: Jaleesa Timberlake, MS    804-477-3045   
Principal Investigator: Robert S Call, MD         
Sub-Investigator: Banks S Turner, MD         
Sub-Investigator: Nancy Pahle, MD         
Sub-Investigator: Patrick A Oliver, MD         
Sponsors and Collaborators
Hill Dermaceuticals, Inc.
Synteract, Inc.
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Study Director: Rosario G Ramirez, MD Hill Dermaceuticals, Inc.

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Responsible Party: Hill Dermaceuticals, Inc. Identifier: NCT03847389    
Other Study ID Numbers: CP0418 SS-P2 051
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs