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

NCT01111123 | Completed Phase 4 Results DMC

• 1 other identifier: GCO 08-1061 0001 01 DE
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Physical Global Assessment

  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.

  During the maintenance phase, from 2 weeks up to 26 weeks

Secondary Outcomes (1)

• Signs of Psoriasis, Atrophy or Telangiectasis

  During the maintenance phase, from 2 weeks up to 26 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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%)

2

PLACEBO COMPARATOR

Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only

Drug: Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment

Interventions

Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%) DRUG

Steroid on weekends only group

1

Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment DRUG

Placebo on weekends only group

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai, Department of Dermatology

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 21386955 RESULT

Limitations and Caveats

The maintenance phase did not have a long enough study duration to capture clinically significant changes in disease status in the steroid group since \>50 percent of the patients at the end of the 24 weeks still remained in the study.

Results Point of Contact

• Title: Jason Emer, MD
• Organization: Mount Siani School of Medicine Department of Dermatology

jason.emer@mssm.edu

2122413288

Study Officials

• Jason J Emer, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 27, 2010
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 24, 2016
• Results First Posted: June 24, 2016

Record last verified: 2016-05

Locations

US (1)