Trial Outcomes & Findings for DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis (NCT NCT02527421)

Last Updated: 2024-03-07

Results Overview

Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

End of Treatment (day 15 or day 28) with recovery 29 days later

Results posted on

2024-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	DFD01 Spray Group 1 DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%	DFD01 Spray Group 2 DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Overall Study STARTED	2	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	DFD01 Spray Group 1 DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%	DFD01 Spray Group 2 DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DFD01 Spray Group 1 n=2 Participants DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%	DFD01 Spray Group 2 n=1 Participants DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: End of Treatment (day 15 or day 28) with recovery 29 days later

Population: Subjects who completed the treatment period

Number of participants with HPA axis suppression at End of Treatment (day 15 or day 28) with recovery 29 days later, by measuring the level of cortisol in the blood after ACTH stimulation test

Outcome measures

Outcome measures
Measure	DFD01 Spray Group 1 n=1 Participants DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%	DFD01 Spray Group 2 n=1 Participants DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Participants With HPA Axis Suppression at End of Treatment (Day 15 or Day 28) With Recovery 29 Days Later	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 29

Number of participants with HPA axis suppression at Day 29, by measuring the level of cortisol in the blood after ACTH stimulation test

Outcome measures

Outcome measures
Measure	DFD01 Spray Group 1 n=1 Participants DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%	DFD01 Spray Group 2 n=1 Participants DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Participants With HPA Axis Suppression at Day 29	0 Participants	1 Participants

Adverse Events

DFD01 Spray Group 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

DFD01 Spray Group 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DFD01 Spray Group 1 n=2 participants at risk DFD01 spray, twice daily, 15 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%	DFD01 Spray Group 2 n=1 participants at risk DFD01 spray, twice daily, 29 days DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Endocrine disorders HPA Axis suppression	50.0% 1/2 • Number of events 1 • 43 days (14-day treatment group) or 57 days (29-day treatment group)	100.0% 1/1 • Number of events 1 • 43 days (14-day treatment group) or 57 days (29-day treatment group)

Additional Information

Robert Babilon President

Prosoft Clinical

Phone: 484 320 2068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No report, abstract, oral presentation, or publication of the results of the Study proposed by Institution shall be presented or published without the prior written consent of the Sponsor or as otherwise permitted for regulatory agency inspections.
Publication restrictions are in place

Restriction type: OTHER