Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis

• Sponsor: Hill Dermaceuticals, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03847389
• Collaborator: Synteract, Inc. (Industry), Covance (Industry)
• Enrollment: 8
• Locations: 6
• Arm: 1
• Actual Duration (Months): 10.6
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: open-label, maximal use, in 3 successive age cohortsopen-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: Sep 9, 2019
• Actual Primary Completion Date: May 2, 2020
• Actual Study Completion Date: Jul 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
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; thin film application of the oil twice daily; Other Names: clobetasol propionate topical solution

Outcome Measures

Primary Outcome Measures

1. Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test) [day 0 and day 15.]

   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.

2. Adverse Events, Including Treatment Emergent Adverse Events (TEAEs) [Days 0, 1, 8 and 15]

   number of events and percentage of subjects with AEs including TEAEs

Other Outcome Measures

1. ISGA Category [Days 0, 1, 8 and 15 Efficacy assessment, including ISGA, was not performed due to premature termination of the study.]

   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

2. Assessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters). [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 18 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Clinical Research - US, LLC	Sanford	Florida	United States	32771
2	AeroAllergy Research Laboratories of Savannah, Inc	Savannah	Georgia	United States	31406
3	Paddington Testing Co., Inc.	Philadelphia	Pennsylvania	United States	19103
4	Spartanburg Medical Research	Spartanburg	South Carolina	United States	29303
5	Progressive Clinical Research	San Antonio	Texas	United States	78213
6	Clinical Research Partners, LLC	Richmond	Virginia	United States	23220

Sponsors and Collaborators

• Hill Dermaceuticals, Inc.
• Synteract, Inc.
• Covance

Investigators

• Study Director: Rosario G Ramirez, MD, Hill Dermaceuticals, Inc.

Study Documents (Full-Text)

• Study Protocol - Jan 28, 2019
• Statistical Analysis Plan - Aug 4, 2020

More Information

Publications

None provided.

• Responsible Party: Hill Dermaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03847389
• Other Study ID Numbers: CP0418 SS-P2 051
• First Posted: Feb 20, 2019
• Last Update Posted: Jun 23, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Clobetasol

Study Results

Participant Flow

Pre-assignment Detail	Enrollment into each successively younger pediatric cohort was to proceed only after the preceding cohort had been completed, and safety and exploratory data reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 proceeded only if the subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%.

Arm/Group Title	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
Arm/Group Description	Cohort 1: ≥12 to <18 years; Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had 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) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Cohort 2: ≥6 to <12 years; Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had 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) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Cohort 3: ≥2 to <6 years Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had 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) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.
Period Title: Overall Study
STARTED	8	0	0
COMPLETED	8	0	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3	Total
Arm/Group Description	Cohort 1: ≥12 to <18 years; At the Baseline/Start of Treatment for Cohort 1, subjects underwent assessments of their AD, baseline (pretreatment) assessments of tolerability criteria, a review of eligibility criteria, a urine pregnancy test and baseline (pretreatment) assessments of AEs. For subjects who remained eligible for the study, the investigator designated the areas to be treated with study drug, and subjects and/or their caregivers applied the first dose of study drug at the site. AEs and tolerability were assessed.	Cohort 2: ≥6 to <12 years; Enrollment from Cohort 1 into Cohort 2 will proceed only after cohort 1 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Cohort 3: ≥2 to <6 years Enrollment from Cohort 2 into Cohort 3 will proceed only after cohort 2 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Total of all reporting groups
Overall Participants	8	0	0	8
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	17	17
Sex: Female, Male (Count of Participants)
Female	6 75%	6 Infinity
Male	2 25%	2 Infinity
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	4 50%	4 Infinity
Not Hispanic or Latino	4 50%	4 Infinity
Region of Enrollment (Count of Participants)
United States	8 100%	8 Infinity
prestimulation serum cortisol level >5 µg/100 mL, (Count of Participants)
Count of Participants [Participants]	8 100%	8 Infinity
post-stimulation cortisol level >18 µg/100 mL (Count of Participants)
Count of Participants [Participants]	8 100%	8 Infinity

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

Subjects met all eligibility criteria and were enrolled. Safety population.

Arm/Group Title	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
Arm/Group Description	Cohort 1: ≥12 to <18 years; Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had 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) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Cohort 2: ≥6 to <12 years; Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had 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) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Cohort 3: ≥2 to <6 years Enrollment into each successively younger pediatric cohort was to have proceeded only after the preceding cohort had 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) had been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 were to have proceeded only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.
Measure Participants	8	0	0
Subjects with post-stimulation cortisol level ≤18 µg/100 mL at Day 0 (before treatment)	0 0%	0 NaN	0 NaN
Subjects with post-stimulation cortisol level ≤18 µg/100 mL at any time during treatment	3 37.5%	0 NaN	0 NaN
Subjects with post-stimulation cortisol level greater than18 µg/100 mL at end of treatment (Day 15)	5 62.5%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects who met eligibility criteria for enrollment

Arm/Group Title	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
Arm/Group Description	Cohort 1: ≥12 to <18 years; At the Baseline/Start of Treatment for Cohort 1, subjects underwent assessments of their AD, baseline (pretreatment) assessments of tolerability criteria, a review of eligibility criteria, a urine pregnancy test and baseline (pretreatment) assessments of AEs. For subjects who remained eligible for the study, the investigator designated the areas to be treated with study drug, and subjects and/or their caregivers applied the first dose of study drug at the site. AEs and tolerability were assessed.	Cohort 2: ≥6 to <12 years; Enrollment from Cohort 1 into Cohort 2 will proceed only after cohort 1 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Cohort 3: ≥2 to <6 years Enrollment from Cohort 2 into Cohort 3 will proceed only after cohort 2 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.
Measure Participants	8	0	0
Subjects without AEs, including treatment emergent adverse events	8 100%	0 NaN	0 NaN
Subjects with AEs	0 0%	0 NaN	0 NaN

3. Other Pre-specified Outcome

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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects that met eligibility criteria for enrollment. Safety population.

Arm/Group Title	Clobetasol Propionate Topical Oil in Cohort 1	Clobetasol Propionate Topical Oil in Cohort 2	Clobetasol Propionate Topical Oil in Cohort 3
Arm/Group Description	Cohort 1: ≥12 to <18 years; At the Baseline/Start of Treatment for Cohort 1, subjects underwent assessments of their AD, baseline (pretreatment) assessments of tolerability criteria, a review of eligibility criteria, a urine pregnancy test and baseline (pretreatment) assessments of AEs. For subjects who remained eligible for the study, the investigator designated the areas to be treated with study drug, and subjects and/or their caregivers applied the first dose of study drug at the site. AEs and tolerability were assessed.	Cohort 2: ≥6 to <12 years; Enrollment from Cohort 1 into Cohort 2 will proceed only after cohort 1 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.	Cohort 3: ≥2 to <6 years Enrollment from Cohort 2 into Cohort 3 will proceed only after cohort 2 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.
Measure Participants	8	0	0
No AEs	8 100%
With AEs	0 0%

Adverse Events

Time Frame	AEs were collected at start of study to termination of the study, approximately 6 months.
Adverse Event Reporting Description	All adverse events (AEs) which started after the start of study drug or which increased from baseline in severity were considered treatment emergent AEs (TEAEs).
Arm/Group Title	Clobetasol Propionate Topical Oil in Cohort 1		Clobetasol Propionate Topical Oil in Cohort 2		Clobetasol Propionate Topical Oil in Cohort 3
Arm/Group Description	Cohort 1: ≥12 to <18 years; At the Baseline/Start of Treatment for Cohort 1, subjects underwent assessments of their AD, baseline (pretreatment) assessments of tolerability criteria, a review of eligibility criteria, a urine pregnancy test and baseline (pretreatment) assessments of AEs. For subjects who remained eligible for the study, the investigator designated the areas to be treated with study drug, and subjects and/or their caregivers applied the first dose of study drug at the site. AEs and tolerability were assessed.		Cohort 2: ≥6 to <12 years; Enrollment from Cohort 1 into Cohort 2 will proceed only after cohort 1 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.		Cohort 3: ≥2 to <6 years Enrollment from Cohort 2 into Cohort 3 will proceed only after cohort 2 had 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) had been reviewed and agreed to be acceptable, and only if the percentage of subjects with HPA axis suppression in Cohort 1 was ≤40%. HPA axis suppression was defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.
All Cause Mortality
	Clobetasol Propionate Topical Oil in Cohort 1		Clobetasol Propionate Topical Oil in Cohort 2		Clobetasol Propionate Topical Oil in Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Clobetasol Propionate Topical Oil in Cohort 1		Clobetasol Propionate Topical Oil in Cohort 2		Clobetasol Propionate Topical Oil in Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Clobetasol Propionate Topical Oil in Cohort 1		Clobetasol Propionate Topical Oil in Cohort 2		Clobetasol Propionate Topical Oil in Cohort 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/0 (NaN)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.