A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155)

A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Pharmacodynamics of MK-0524 in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea. (Protocol No. 155)

This study will assess the effect of MK-0524 relative to placebo, on signs and symptoms of rosacea and to determine the safety and tolerability profile of MK-0524 in participants with rosacea.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Laropiprant; Drug: Placebo for Laropiprant

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Moderate to severe erythematotelangiectatic rosacea with moderate to severe erythema of facial lesion
• Generally healthy excluding rosacea
• Presence of telangiectasia
• Five or less facial inflammatory lesions
• Able to restrict diet in order to avoid foods/drinks (including alcohol) that are known to exacerbate the signs/symptoms of rosacea
• Females of childbearing potential must have negative serum pregnancy test and agree to use one form of contraception

Exclusion Criteria:

• Diagnosis of skin disorders, including psoriasis, acne vulgaris, perioral dermatitis or atopic dermatitis that would interfere with the clinical evaluations of rosacea
• Using and unable to discontinue use of phosphodiesterase (PDE) 4 inhibitors, theophylline, niacin greater than 500 mg/day
• Known or suspected excessive alcohol intake
• Sensitivity to tetracyclines
• Ocular rosacea and/or blepharitis/meibomianitis
• Pregnant or breastfeeding
• Perimenopausal and has symptoms that cause flushing that may affect rosacea
• Initiated hormonal method of birth contraception within 4 months of baseline, discontinues use during the course of the study, or changes hormonal method within 4 months
• Active mycobacterial infection of any species within 3 years
• History of mycobacterium tuberculosis infection
• History of recurrent bacterial infection
• Congenital or acquired immunodeficiency common variable immunodeficiency (CVID), Hepatitis B surface antigen positive or Hepatitis B core antibody positive
• Human immunodeficiency virus (HIV) infection
• Positive for hepatitis C antibodies
• Malignancy or has had a history of malignancy greater than 3 years prior
• Will continue to use any of the following treatments during the study: Systemic retinoids, therapeutic vitamin A supplements of greater than 10,000 units/day, systemic steroids, systemic antibiotics known to have an impact on the severity of facial rosacea, systemic treatment for acne, topical steroids, topical retinoids, topical acne treatments including prescription and over-the-counter (OTC) preparations, topical anti-inflammatory agents, topical antibiotics, topical imidazole antimycotics, cryodestruction or chemodestruction, dermabrasion, photodynamic therapy, acne surgery, intralesional steroids, X-ray therapy, pulse-dye laser, intense pulse light, astringents, abrasives, benzoyl peroxide products, sulfur containing washes, eye washes, Beta blockers, vasodilators, vasoconstrictors and/or chronic use (>14 days) of topical or systemic anti-inflammatory agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo for Laropiprant; One tablet orally once daily for 4 weeks
Experimental: Laropiprant	Drug: Laropiprant; One 100-mg tablet orally once daily for 4 weeks; Other Names: MK-0524

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Patient Self Assessment (PSA) Score from Baseline	Baseline and Week 4

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Krishna R, Guo Y, Schulz V, Cord-Cruz E, Smith S, Hair S, Nahm WK, Draelos ZD. Non-obligatory role of prostaglandin D2 receptor subtype 1 in rosacea: laropiprant in comparison to a placebo did not alleviate the symptoms of erythematoelangiectaic rosacea. J Clin Pharmacol. 2015 Feb;55(2):137-43. doi: 10.1002/jcph.383. Epub 2014 Sep 4.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: October 11, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 13, 2011

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 0524-155