Trial Outcomes & Findings for Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis (NCT NCT01166646)

Last Updated: 2016-05-16

Results Overview

Hypothalamic Pituitary-Adrenal (HPA)-Axis responses to Cosyntropin Stimulation Testing (CST) were dichotomized to normal and abnormal. An abnormal HPA Axis response (HPA Suppression) was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at the end of treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

After 1-2 weeks dose

Results posted on

2016-05-16

Participant Flow

Recruitment period: August 2010 to May 2011 The location of clinical sites included private dermatology clinics and clinical research centers.

All subjects who met the entry criteria were randomized and enrolled into the study.

Participant milestones

Participant milestones
Measure	Halobetasol Proprionate Lotion 0.05% Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Overall Study STARTED	21	22
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Halobetasol Proprionate Lotion 0.05% Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Overall Study Protocol Violation	0	1
Overall Study Adverse Event	1	0

Baseline Characteristics

Blinded Study of Topical Investigational Lotion Vs. Approved Cream in Treatment of Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Halobetasol Proprionate Lotion 0.05% n=21 Participants Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% n=22 Participants Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Total n=43 Participants Total of all reporting groups
Age, Continuous	49.5 years STANDARD_DEVIATION 9.28 • n=5 Participants	47.7 years STANDARD_DEVIATION 12.57 • n=7 Participants	48.5 years STANDARD_DEVIATION 11.00 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	17 Participants n=7 Participants	36 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 1-2 weeks dose

Population: Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.

Outcome measures

Outcome measures
Measure	Halobetasol Proprionate Lotion 0.05% n=21 Participants Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% n=21 Participants Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Adrenal Suppression Potential Normal	16 participants	18 participants
Adrenal Suppression Potential Abnormal	5 participants	3 participants

PRIMARY outcome

Timeframe: Day 8

Population: Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.

Comparison of PK results (peak concentration in plasma \[Cmax\]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.

Outcome measures

Outcome measures
Measure	Halobetasol Proprionate Lotion 0.05% n=12 Participants Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% n=12 Participants Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Pharmacokinetic Properties (Cmax)	145.9 pg/mL Geometric Coefficient of Variation 106.9	136.2 pg/mL Geometric Coefficient of Variation 71.44

PRIMARY outcome

Timeframe: Day 8

Population: Pharmacokinetic properties were evaluated in a subgroup of 12 adult subjects per arm.

Comparison of PK results (time to peak concentration \[Tmax\]) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.

Outcome measures

Outcome measures
Measure	Halobetasol Proprionate Lotion 0.05% n=12 Participants Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% n=12 Participants Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Pharmacokinetic Properties (Tmax)	3 Hours Interval 0.0 to 6.0	3 Hours Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: Day 8

Population: Pharmacokinetics properties were evaluated in a subgroup of 12 adult subjects per arm.

Comparison of PK results (area under the curve \[AUC\] from time 0 to infinity) between the two Treatment Groups will be conducted following the last application of the medication on Day 8.

Outcome measures

Outcome measures
Measure	Halobetasol Proprionate Lotion 0.05% n=12 Participants Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% n=12 Participants Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Pharmacokinetic Properties (AUC)	1267.7 pg*h/mL Geometric Coefficient of Variation 89.84	1229.8 pg*h/mL Geometric Coefficient of Variation 67.19

SECONDARY outcome

Timeframe: Day 15

Population: Analysis shown is based on the ITT population at Day 15.

Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. ODS evaluations will be dichotomized to "success" and "failure" with success defined as a grade of 1 or 0 at the end of treatment (EOT).

Outcome measures

Outcome measures
Measure	Halobetasol Proprionate Lotion 0.05% n=21 Participants Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% n=22 Participants Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Changes in Disease Severity (Success)	1 participants	5 participants

SECONDARY outcome

Timeframe: Day 15

Population: Analysis shown is based on the number of subjects whose Signs of Psoriasis was designated "Success" (ITT population) at Day 15.

Signs of psoriasis including scaling, erythema, and plaque elevation will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. Each of the signs of psoriasis will be dichotomized to a) "success" and "failure" with success defined as a grade of 1 or 0 at the End of Treatment (EOT; i.e., the visit at which psoriasis has cleared \[Day 8 or Day 15\] or end of the assigned treatment period).

Outcome measures

Outcome measures
Measure	Halobetasol Proprionate Lotion 0.05% n=21 Participants Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks	Halobetasol Proprionate Cream 0.05% n=22 Participants Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks
Number of Subjects Whose Signs of Psoriasis Was Designated "Success" Scaling	6 participants	11 participants
Number of Subjects Whose Signs of Psoriasis Was Designated "Success" Erythema	2 participants	6 participants
Number of Subjects Whose Signs of Psoriasis Was Designated "Success" Plaque elevation	2 participants	7 participants

Adverse Events

Halobetasol Proprionate Lotion 0.05%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Halobetasol Proprionate Cream 0.05%

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Research, Therapeutics Inc.

Therapeutics, Inc.

Phone: 858-571-1800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public dissemination. The PI may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Halobetasol Proprionate Lotion 0.05% n=21 participants at risk Subjects randomized to receive lotion Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for 1-2 weeks	Halobetasol Proprionate Cream 0.05% n=22 participants at risk Subjects randomized to receive cream Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for 1-2 weeks
Endocrine disorders Type 2 diabetes mellitus	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Gastrointestinal disorders Nausea	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	4.5% 1/22 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
General disorders Application site pain	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	4.5% 1/22 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
General disorders Feeling hot	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
General disorders Pallor	0.00% 0/21 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	4.5% 1/22 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Infections and infestations Influenza	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Infections and infestations nasopharyngitis	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	4.5% 1/22 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Infections and infestations Throat infection	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Infections and infestations Tooth infection	0.00% 0/21 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	4.5% 1/22 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Infections and infestations Upper respiratory tract infection	0.00% 0/21 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	9.1% 2/22 • Number of events 2 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/21 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	4.5% 1/22 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Injury, poisoning and procedural complications Procedural nausea	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/21 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	4.5% 1/22 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Investigations ACTH stimulation test abnormal	23.8% 5/21 • Number of events 5 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	13.6% 3/22 • Number of events 3 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Renal and urinary disorders Nephrolithiasis	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Renal and urinary disorders Renal pain	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.
Skin and subcutaneous tissue disorders Pruritus	4.8% 1/21 • Number of events 1 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.	0.00% 0/22 • AEs were collected from study screening (performed 14 days prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization. The Safety population included all subjects enrolled in the study who were dispensed the test article at least once.