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

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ClinicalTrials.gov Identifier: NCT01451619
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Rosacea Drug: Laropiprant Drug: Placebo for Laropiprant Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Laropiprant Drug: Laropiprant
One 100-mg tablet orally once daily for 4 weeks
Other Name: MK-0524

Placebo Comparator: Placebo Drug: Placebo for Laropiprant
One tablet orally once daily for 4 weeks




Primary Outcome Measures :
  1. Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline [ Time Frame: Baseline and Week 4 ]

Secondary Outcome Measures :
  1. Change in Patient Self Assessment (PSA) Score from Baseline [ Time Frame: Baseline and Week 4 ]


Information from the National Library of Medicine

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

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