TerminatedNCT03847389Updated Jun 23, 2021Results posted

Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis

A Phase 1/2 interventional study of Clobetasol propionate 0.05% Topical Oil in Atopic Dermatitis, sponsored by Hill Dermaceuticals, Inc.. Terminated at 6 sites in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-06-23.

Sponsored by Hill Dermaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated

Difficulty in enrollment and COVID-19 pandemic.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 2 Years to 18 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Atopic Dermatitis

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In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 8 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

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Lead sponsor

Hill Dermaceuticals, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 18 Years
Sexes eligible: 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

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

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Other
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

Interventions

DrugClobetasol propionate 0.05% Topical Oil
thin film application of the oil twice daily
Also known as: clobetasol propionate topical solution

What researchers measure

Primary outcomes

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.
Time frame: day 0 and day 15.
Adverse Events, Including Treatment Emergent Adverse Events (TEAEs)
number of events and percentage of subjects with AEs including TEAEs
Time frame: Days 0, 1, 8 and 15

Other outcomes

ISGA Category
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
Time frame: Days 0, 1, 8 and 15 Efficacy assessment, including ISGA, was not performed due to premature termination of the study.
Assessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters).
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

Results

Posted Jun 23, 2021

Limitations and caveats

The study was terminated early due to the COVID pandemic with very low subject enrollment. Due to the small number of subjects that completed when the study was prematurely terminated, pharmacokinetic, exploratory, sensitivity, as well as some safety analyses was not completed under the SAP.

Participant flow

Participant flow — Overall Study
Milestone	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
Started	8	0	0
Completed	8	0	0
Not completed	0	0	0

Outcome measures

PrimaryNumber 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.

Time frame:: day 0 and day 15.
Reported as:: Count of participants · Participants

Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test)
Participants	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
Subjects with post-stimulation cortisol level ≤18 µg/100 mL at Day 0 (before treatment)	0	0	0
Subjects with post-stimulation cortisol level ≤18 µg/100 mL at any time during treatment	3	0	0
Subjects with post-stimulation cortisol level greater than18 µg/100 mL at end of treatment (Day 15)	5	—	—

PrimaryAdverse Events, Including Treatment Emergent Adverse Events (TEAEs)

number of events and percentage of subjects with AEs including TEAEs

Time frame:: Days 0, 1, 8 and 15
Reported as:: Count of participants · Participants

Adverse Events, Including Treatment Emergent Adverse Events (TEAEs)
Participants	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
Subjects without AEs, including treatment emergent adverse events	8	0	0
Subjects with AEs	0	0	0

Other pre-specifiedISGA Category

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

Time frame:: Days 0, 1, 8 and 15 Efficacy assessment, including ISGA, was not performed due to premature termination of the study.

Results for this outcome have not been posted.

Other pre-specifiedAssessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters).

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
Reported as:: Count of participants · Participants

Assessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters).
Participants	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
No AEs	8	—	—
With AEs	0	—	—

Adverse events

Collected over AEs were collected at start of study to termination of the study, approximately 6 months.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Clobetasol Propionate Topical Oil in Cohort 1	0/8 (0%)	0/8 (0%)	0/8 (0%)
Clobetasol Propionate Topical Oil in Cohort 2	—	—	—
Clobetasol Propionate Topical Oil in Cohort 3	—	—	—

Baseline characteristics

Study was terminated prior to enrolling participants in cohort 2 or cohort 3.

Age, Continuous
Age, Continuous(years)	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3	Total
Median	17 (12 to 18)	—	—	17 (12 to 18)

Sex: Female, Male
Sex: Female, Male(Participants)	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3	Total
Female	6	—	—	6
Male	2	—	—	2

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3	Total
Hispanic or Latino	4	—	—	4
Not Hispanic or Latino	4	—	—	4

Region of Enrollment
Region of Enrollment(Participants)	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3	Total
United States	8	—	—	8

prestimulation serum cortisol level >5 µg/100 mL,
prestimulation serum cortisol level >5 µg/100 mL,(Participants)	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3	Total
Count of participants	8	—	—	8

post-stimulation cortisol level >18 µg/100 mL
post-stimulation cortisol level >18 µg/100 mL(Participants)	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3	Total
Count of participants	8	—	—	8

Study locations

6 sites

International Clinical Research - US, LLC
Sanford, Florida 32771, United States
AeroAllergy Research Laboratories of Savannah, Inc
Savannah, Georgia 31406, United States
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania 19103, United States
Spartanburg Medical Research
Spartanburg, South Carolina 29303, United States
Progressive Clinical Research
San Antonio, Texas 78213, United States
Clinical Research Partners, LLC
Richmond, Virginia 23220, United States

References and documents

Study documents

Study protocol · Jan 28, 2019
Statistical analysis plan · Aug 4, 2020

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03847389
Lead sponsor: Hill Dermaceuticals, Inc.
Collaborators: Synteract, Inc., Covance
Responsible party: Sponsor
First posted: Feb 20, 2019
Start date: Sep 9, 2019
Primary completion: May 2, 2020
Completion: Jul 28, 2020
Results posted: Jun 23, 2021
Last update: Jun 23, 2021

Study contacts

Rosario G Ramirez, MD

study director · Hill Dermaceuticals, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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