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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Laropiprant
* Drug: Placebo for Laropiprant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laropiprant<br> | Drug: Laropiprant<br>* One 100-mg tablet orally once daily for 4 weeks<br>* Other names: MK-0524;|
| Placebo Comparator: Placebo<br> | Drug: Placebo for Laropiprant<br>* One tablet orally once daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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