Trial Outcomes & Findings for Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 (NCT NCT03179605)

Last Updated: 2024-03-07

Results Overview

The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Day 15

Results posted on

2024-03-07

Participant Flow

Normal response to cosyntropin stimulation defined as a Screening Cosyntropin Stimulation Test (CST) with a 30-minute post-stimulation cortisol level of \> 18 ug/dL.

Participant milestones

Participant milestones
Measure	DFD-06 Cream This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DFD-06 Cream This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DFD-06 Cream n=22 Participants This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days
Age, Continuous	14.2 years STANDARD_DEVIATION 1.54 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
Investigator Global Assessment	3 units on a scale STANDARD_DEVIATION 0 • n=5 Participants
Percent Body Surface Area Affected	14.2 percent body surface area n=5 Participants

PRIMARY outcome

Timeframe: Day 15

Population: The Evaluable population included those subjects in the Safety population who had both Screening and Day 15 serum cortisol data (pre- and post-cosyntropin stimulation) and had a normal response to Screening Cosyntropin Stimulation Test with a 30-minute post-stimulation cortisol level of \> 18 μg/dL and applied at least 80% of expected (29) applications

The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable

Outcome measures

Outcome measures
Measure	DFD-06 Cream n=21 Participants This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days
Percentage of Subjects With HPA Axis Suppression at Day 15	3 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 15

Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics.

Outcome measures

Outcome measures
Measure	DFD-06 Cream n=21 Participants This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days
Number of Participants With Improvement in IGA Grade From Baseline Day 8 1-point improvement in IGA	15 participants
Number of Participants With Improvement in IGA Grade From Baseline Day 8 2-point improvement in IGA	2 participants
Number of Participants With Improvement in IGA Grade From Baseline Day 15 1 point improvement in IGA	8 participants
Number of Participants With Improvement in IGA Grade From Baseline Day 15 2-point improvement in IGA	10 participants
Number of Participants With Improvement in IGA Grade From Baseline Day 15 3-point improvement in IGA	2 participants

SECONDARY outcome

Timeframe: Day 15 0 hour, 1 hour, 3 hours, 6 hours after application

Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation.

Outcome measures

Outcome measures
Measure	DFD-06 Cream n=8 Participants This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days
Plasma Concentration of Clobetasol Propionate 0 hour clobetasol plasma level	51.486 pg/mL Standard Deviation 48.35
Plasma Concentration of Clobetasol Propionate 1 hour clobetasol plasma level	40.370 pg/mL Standard Deviation 32.55
Plasma Concentration of Clobetasol Propionate 3 hour clobetasol plasma level	64.250 pg/mL Standard Deviation 41.93
Plasma Concentration of Clobetasol Propionate 6 hour clobetasol plasma level	42.143 pg/mL Standard Deviation 27.32
Plasma Concentration of Clobetasol Propionate Average of 1, 3 and 6 hour	45.47 pg/mL Standard Deviation 32.49

Adverse Events

DFD-06 Cream

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DFD-06 Cream n=22 participants at risk This is a single arm, open label study and there will be no reference or control product used in this study DFD06: Apply twice per day for 15 days
Endocrine disorders HPA Axis Suppression	13.6% 3/22 • Number of events 3 • 1 month Adverse events were collected at every visit (except Screening) by spontaneous reports from subjects and legal guardian, either verbal or recorded in the subject diary, by directed questioning of subjects and legal guardian, and by observation.
Skin and subcutaneous tissue disorders Application Site Pruritus	13.6% 3/22 • Number of events 3 • 1 month Adverse events were collected at every visit (except Screening) by spontaneous reports from subjects and legal guardian, either verbal or recorded in the subject diary, by directed questioning of subjects and legal guardian, and by observation.
Skin and subcutaneous tissue disorders Application Site Pain	4.5% 1/22 • Number of events 1 • 1 month Adverse events were collected at every visit (except Screening) by spontaneous reports from subjects and legal guardian, either verbal or recorded in the subject diary, by directed questioning of subjects and legal guardian, and by observation.
Vascular disorders Vein collapse	4.5% 1/22 • Number of events 1 • 1 month Adverse events were collected at every visit (except Screening) by spontaneous reports from subjects and legal guardian, either verbal or recorded in the subject diary, by directed questioning of subjects and legal guardian, and by observation.

Additional Information

Robert Babilon President

Prosoft Clinical

Phone: 4843202068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place