Trial Outcomes & Findings for Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05% (NCT NCT03212963)

Results Overview

The IGA score (5-point scale of 0 to 4: 0\[clear\]; 1\[almost clear\]; 2\[mild\]; 3\[moderate\]; 4\[severe\]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

Day 15

Results posted on

2021-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	Halobetasol Lotion Treatment Arm All subjects will receive Halobetasol Topical Lotion, 0.05%. Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Halobetasol Lotion Treatment Arm n=16 Participants All subjects will receive Halobetasol Topical Lotion, 0.05%. Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Age, Continuous	14.1 years STANDARD_DEVIATION 1.51 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 15

The IGA score (5-point scale of 0 to 4: 0\[clear\]; 1\[almost clear\]; 2\[mild\]; 3\[moderate\]; 4\[severe\]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).

Outcome measures

Outcome measures
Measure	Halobetasol Lotion Treatment Arm n=14 Participants All subjects will receive Halobetasol Topical Lotion, 0.05%. Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Investigator's Global Assessment IGA Grade 0	5 number of subjects
Investigator's Global Assessment IGA Grade 1	3 number of subjects
Investigator's Global Assessment IGA Grade 2	4 number of subjects
Investigator's Global Assessment IGA Grade 3	2 number of subjects
Investigator's Global Assessment IGA Grade 4	0 number of subjects

PRIMARY outcome

Timeframe: Day 15

Population: Evaluable Population

The Percent Body Surface Area (BSA) Affected with Disease was defined as the BSA which was affected with psoriasis within the Treatment Area.

Outcome measures

Outcome measures
Measure	Halobetasol Lotion Treatment Arm n=14 Participants All subjects will receive Halobetasol Topical Lotion, 0.05%. Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Percent BSA Affected With Disease	2.8 percentage of body surface area Standard Deviation 3.04

PRIMARY outcome

Timeframe: Day 8

Population: Evaluable Population

The Percent Body Surface Area Treated with Test Article was defined as the BSA which was affected with psoriasis within the Treatment Area that was treated.

Outcome measures

Outcome measures
Measure	Halobetasol Lotion Treatment Arm n=14 Participants All subjects will receive Halobetasol Topical Lotion, 0.05%. Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Percent Body Surface Area Treated With Test Article	7.1 percentage of body surface area Standard Deviation 1.98

PRIMARY outcome

Timeframe: Day 15

Population: Evaluable Population

An abnormal Hypothalamus-Pituitary-Adrenal (HPA) axis was response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS)

Outcome measures

Outcome measures
Measure	Halobetasol Lotion Treatment Arm n=14 Participants All subjects will receive Halobetasol Topical Lotion, 0.05%. Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response	1 number of subjects Interval 0.2 to 33.9

Adverse Events

Halobetasol Lotion Treatment Arm

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	Halobetasol Lotion Treatment Arm n=16 participants at risk All subjects will receive Halobetasol Topical Lotion, 0.05%. Halobetasol Topical Lotion: Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
Investigations ACTH stimulation test abnormal	6.2% 1/16 • Number of events 1 • Day 15

Additional Information

Head, Clinical Development

Sun Pharma Advanced Research Company Ltd.

Phone: 912266455645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place