Trial Outcomes & Findings for Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis (NCT NCT00990561)

Results Overview

PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

2 weeks

Results posted on

2019-01-04

Participant Flow

Patients were recruited from our medical clinic as well as through flyers posted at other University of California at San Francisco sites.

Patients were required to have a 2 week washout from topicals, 1 month washout from any systemic agents.

Participant milestones

Participant milestones
Measure	Twice Daily Topical Ultravate Ointment + LacHyrin Twice Daily	Once Daily Topical Ultravate Ointment + LacHydrin Lotion	Lac-Hydrin Topically Twice a Day	No Treatment
Period 1 STARTED	20	20	0	0
Period 1 COMPLETED	20	19	0	0
Period 1 NOT COMPLETED	0	1	0	0
Period 2 STARTED	0	0	20	19
Period 2 COMPLETED	0	0	20	17
Period 2 NOT COMPLETED	0	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing the Efficacy of Ultravate Ointment in Combination With Lac-Hydrin Lotion in the Treatment of Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultravate Twice a Day n=20 Participants	Ultravate Once a Day n=20 Participants Ultravate ointment applied once daily	Total n=40 Participants Total of all reporting groups
Age, Continuous	NA Years n=5 Participants	NA Years n=7 Participants	44.2 Years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: This was a pilot study and the number was based on the available budget to perform the study.

PASI is a scale that measures psoriasis severity based on erythema, induration, scaling, and body surface area covered. It ranges from 0 (no disease) to 72 (most extensive).

Outcome measures

Outcome measures
Measure	Ultravate 0.05% Ointment Twice Daily n=20 Participants Ultravate twice daily to affected area.	Ultravate 0.05% Ointment Once Daily n=20 Participants Ultravate one daily to affected area.
Change in Modified Psoriasis Area Severity Index (PASI) Score	2.6 units on a scale Interval 2.6 to 3.1	3 units on a scale Interval 2.4 to 3.5

Adverse Events

Ultravate Twice a Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultravate Once a Day

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

John Koo, Principle Investigator

UCSF

Phone: 415-476-4701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place