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

Phase 1

Completed

• Conditions: Rosacea
• Interventions: Drug: Placebo for Laropiprant; Drug: Laropiprant

• Registration Number: NCT01451619
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-13
• Study Start: 2011-11
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo for Laropiprant	-
Laropiprant	Laropiprant	-

Primary Outcome Measures

Name	Time	Method
Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline	Baseline and Week 4

Secondary Outcome Measures

Name	Time	Method
Change in Patient Self Assessment (PSA) Score from Baseline	Baseline and Week 4