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Completed Phase 4 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT00990561

Public ClinicalTrials.gov record NCT00990561. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 11:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Clinical Study Comparing the Efficacy of Ultravate Ointment Once Daily vs. Twice Daily in Combination With Lac-Hydrin Lotion in the Treatment of Stable Plaque Psoriasis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an investigator-masked, randomized, parallel, clinical study comparing the efficacy of once daily versus twice daily application of Ultravate® ointment (halobetasol propionate 0.05% ointment) in combination with Lac-Hydrin lotion (ammonium lactate topical) in the treatment of stable plaque psoriasis. 1) Phase 1: Patients will be treated for two weeks with combination therapy using Ultravate® ointment with Lac-Hydrin lotion and their psoriasis plaques will be evaluated to test efficacy of the medication. Half the subjects will be randomized to receive treatment with once a day Ultravate® ointment and twice daily Lac-Hydrin lotion; the other half of subjects will receive twice daily Ultravate® ointment with twice daily Lac-Hydrin lotion. Ultravate® ointment will be discontinued following two weeks of treatment, in compliance with its FDA indication. Phase 2: The second treatment phase will consist of a four-week observation period. Subjects will be re-randomized to either continue using twice daily Lac-Hydrin lotion, versus no treatment. The purpose of this second phase of the study is to investigate whether use of Lac-Hydrin monotherapy twice daily can minimize risk of recurrence and maximize duration of therapeutic effect. Part of this clinical study consists of the use of patient and physician satisfaction questionnaires. These questionnaires will include questions about the satisfaction with the formulation of each agent, questions about compliance with treatment, etc. Such questions could be used to demonstrate patient and physician satisfaction with each agent, with combination therapy, and to compare patient satisfaction rates among those randomized to once daily versus twice daily application of Ultravate® ointment. The hypothesis is that Ultravate ointment once daily in combination with Lac-Hydrin twice daily is equal in efficacy to Ultravate ointment twice daily in combination with Lac-Hydrin twice daily.

Study identification

NCT ID
NCT00990561
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2009
Primary completion
May 31, 2010
Completion
May 31, 2010
Last update posted
Jan 3, 2019

2009 – 2010

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UCSF Psoriasis and Skin Treatment Center San Francisco California 94118

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00990561, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 3, 2019 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00990561 live on ClinicalTrials.gov.

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