Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis

• ClinicalTrials.gov Identifier: NCT01111123
• Recruitment Status: Completed
• First Posted: April 27, 2010
• Results First Posted: June 24, 2016
• Last Update Posted: June 24, 2016
• Sponsor: Icahn School of Medicine at Mount Sinai
• Information provided by (Responsible Party): Icahn School of Medicine at Mount Sinai

Study Description

Brief Summary:

The purpose of this study is to determine whether the combinational use of ammonium lactate lotion 12% (Lac-Hydrin) and halobetasol propionate ointment 0.05% (Ultravate) is safe and effective in the initial treatment and long-term maintenance of psoriasis. Patients will use both medications continuously for two weeks and those who obtain a good improvement based on investigator clinical assessments will be randomized to Lac-Hydrin lotion twice daily every day with placebo ointment or Ultravate ointment twice daily on weekends only for up to 24 more weeks.

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%); Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment	Phase 4

Detailed Description:

This is a randomized, double-blind, placebo-controlled, clinical trial assessing the efficacy of Ultravate ointment in combination with Lac-Hydrin lotion in the treatment of plaque psoriasis. In the first phase, patients will be treated for two weeks with combination therapy using Ultravate ointment twice daily along with Lac-Hydrin lotion twice daily. After two weeks, psoriasis plaques will be evaluated to test treatment efficacy. Those patients with a significant clinical improvement per investigator clinical assessments, will be randomized in a 1:1 fashion into a maintenance phase and receive Lac-Hydrin lotion twice daily everyday with placebo ointment or Ultravate ointment twice daily on weekends only. Continuous use of Ultravate ointment will be discontinued following two weeks of treatment in compliance with its FDA indication. Patients will be evaluated every 4 weeks (monthly) through the maintenance phase. The purpose of this second phase of the study is to investigate whether use of Ultravate on weekends only can minimize risk of plaque recurrence, maximize duration of therapeutic effect, while limiting the need for the use of long-term continuous topical corticosteroid treatment. As well, the second phase of the study is to investigate whether twice daily Lac-Hydrin lotion has an impact in maximizing the duration of therapeutic effect as well as minimizing local cutaneous side effects such as skin atrophy and telangiectasia. Part of this clinical study consists of the use of patient and self-assessment questionnaires and the use of non-identifying digital photography of target lesions. The hypothesis is that Ultravate ointment on weekends only will be statistically more efficacious at maintaining an excellent initial clinical response and its combination with Lac-Hydrin lotion will help to minimize any local cutaneous side effects as well as enhance its therapeutic effect.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind Study to Evaluate the Efficacy of Ammonium Lactate Lotion 12% (Lac-hydrin®) and Halobetasol Propionate Ointment 0.05% (Ultravate®) in the Treatment and Maintenance of Psoriasis.
• Study Start Date: January 2009
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only	Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%); Steroid on weekends only group
Placebo Comparator: 2; Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only	Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment; Placebo on weekends only group

Outcome Measures

Primary Outcome Measures :

1. Physical Global Assessment [ Time Frame: During the maintenance phase, from 2 weeks up to 26 weeks ]
   Physician global assessment (PGA) score - the physician's impression of the disease at a single time point rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe.

Secondary Outcome Measures :

1. Signs of Psoriasis, Atrophy or Telangiectasis [ Time Frame: During the maintenance phase, from 2 weeks up to 26 weeks ]
   Signs of psoriasis (erythema, induration, and scale) - physician's assessment of the severity of each of the three key characteristics of psoriatic lesions rated as: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, and 5=very severe, combined into one score.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subjects must be at least 18 years of age and in good general health as confirmed by a medical history.
• Females of childbearing potential must have a negative urine pregnancy test on Day 1 and must agree to use adequate birth control methods during the entire study.
• A clear diagnosis of plaque psoriasis must have been previously established and the disease must have been present at least 6 months.
• Subjects must have lesions suitable for evaluating response to test agents. The severity of the disease at Day 1 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation).
• Subjects must be able to understand the requirements of the study, abide by the restrictions, and return for the required examinations. All subject must sign the statement of informed consent approved for the study.

Exclusion Criteria:

• Subjects who are pregnant (determined from a urine pregnancy test on Day 1).
• Subjects who are nursing.
• Subjects with known hypersensitivity to any components of the test medication.
• Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines).
• Subjects using biologics or any other systemic treatment for psoriasis within 12 weeks of entering the study.
• Subjects using systemic corticosteroids within 28 days of entering the study; subjects using topical corticosteroids or other topical therapies (other than emollients) at any location on the body within 1 week of entering the study.
• Subjects with overt pre-existing telangiectasia or skin atrophy at intended treatment sites.
• Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.

Contacts and Locations

Locations

United States, New York

Icahn School of Medicine at Mount Sinai, Department of Dermatology

New York, New York, United States, 10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Jason J Emer, MD; Icahn School of Medicine at Mount Sinai

More Information

Publications of Results:

Emer JJ, Frankel A, Sohn A, Lebwohl M. A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Ammonium Lactate Lotion 12% and Halobetasol Propionate Ointment 0.05% in the Treatment and Maintenance of Psoriasis. J Clin Aesthet Dermatol. 2011 Feb;4(2):28-39.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT01111123 History of Changes
• Other Study ID Numbers: GCO 08-1061 0001 01 DE
• First Posted: April 27, 2010
• Results First Posted: June 24, 2016
• Last Update Posted: June 24, 2016
• Last Verified: May 2016

Keywords provided by Icahn School of Medicine at Mount Sinai:

plaque psoriasis; lac-hydrin; ammonium lactate; Ultravate; halobetasol propionate; weekend only application; topical therapy; topical corticosteroid; class I steroid

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Clobetasol; Halobetasol; Vasoconstrictor Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs