A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01451619
First received: October 11, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Rosacea
Drug: Laropiprant
Drug: Placebo for Laropiprant
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Patient Self Assessment (PSA) Score from Baseline [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01451619     History of Changes
Other Study ID Numbers: MK-0524-155
Study First Received: October 11, 2011
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014