Trial Outcomes & Findings for Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis (NCT NCT03847389)
NCT ID: NCT03847389
Last Updated: 2021-06-23
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
day 0 and day 15.
Results posted on
2021-06-23
Participant Flow
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%.
Participant milestones
| Measure |
Clobetasol Propionate Topical Oil in Cohort 1
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.
|
Clobetasol Propionate Topical Oil in Cohort 2
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.
|
Clobetasol Propionate Topical Oil in Cohort 3
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
0
|
|
Overall Study
COMPLETED
|
8
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Clobetasol Propionate Topical Oil in Cohort 1
n=8 Participants
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.
|
Clobetasol Propionate Topical Oil in Cohort 2
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.
|
Clobetasol Propionate Topical Oil in Cohort 3
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
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
17 years
n=99 Participants
|
—
|
—
|
17 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
—
|
—
|
6 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
—
|
—
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=99 Participants
|
—
|
—
|
4 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
—
|
—
|
4 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=99 Participants
|
—
|
—
|
8 Participants
n=7 Participants
|
|
prestimulation serum cortisol level >5 µg/100 mL,
|
8 Participants
n=99 Participants
|
—
|
—
|
8 Participants
n=7 Participants
|
|
post-stimulation cortisol level >18 µg/100 mL
|
8 Participants
n=99 Participants
|
—
|
—
|
8 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: day 0 and day 15.Population: Subjects met all eligibility criteria and were enrolled. Safety population.
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.
Outcome measures
| Measure |
Clobetasol Propionate Topical Oil in Cohort 1
n=8 Participants
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.
|
Clobetasol Propionate Topical Oil in Cohort 2
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.
|
Clobetasol Propionate Topical Oil in Cohort 3
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.
|
|---|---|---|---|
|
Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test)
Subjects with post-stimulation cortisol level ≤18 µg/100 mL at Day 0 (before treatment)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test)
Subjects with post-stimulation cortisol level ≤18 µg/100 mL at any time during treatment
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With HPA Axis Suppression - Serum Cortisol Concentration (Cortrosyn Stimulation Test)
Subjects with post-stimulation cortisol level greater than18 µg/100 mL at end of treatment (Day 15)
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 0, 1, 8 and 15Population: All subjects who met eligibility criteria for enrollment
number of events and percentage of subjects with AEs including TEAEs
Outcome measures
| Measure |
Clobetasol Propionate Topical Oil in Cohort 1
n=8 Participants
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.
|
Clobetasol Propionate Topical Oil in Cohort 2
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.
|
Clobetasol Propionate Topical Oil in Cohort 3
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.
|
|---|---|---|---|
|
Adverse Events, Including Treatment Emergent Adverse Events (TEAEs)
Subjects without AEs, including treatment emergent adverse events
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events, Including Treatment Emergent Adverse Events (TEAEs)
Subjects with AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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: 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 8 and 15Population: All subjects that met eligibility criteria for enrollment. Safety population.
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).
Outcome measures
| Measure |
Clobetasol Propionate Topical Oil in Cohort 1
n=8 Participants
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.
|
Clobetasol Propionate Topical Oil in Cohort 2
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.
|
Clobetasol Propionate Topical Oil in Cohort 3
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.
|
|---|---|---|---|
|
Assessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters).
No AEs
|
8 Participants
|
—
|
—
|
|
Assessment of Burning/Stinging, Skin Atrophy, Striae, Folliculitis, and Telangiectasias (Tolerability Parameters).
With AEs
|
0 Participants
|
—
|
—
|
Adverse Events
Clobetasol Propionate Topical Oil in Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clobetasol Propionate Topical Oil in Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clobetasol Propionate Topical Oil in Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place