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

October 11, 2011
May 8, 2012
November 2011
April 2012   (final data collection date for primary outcome measure)
Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01451619 on ClinicalTrials.gov Archive Site
Change in Patient Self Assessment (PSA) Score from Baseline [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155 AM1)
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rosacea
  • Drug: Laropiprant
    One 100-mg tablet orally once daily for 4 weeks
    Other Name: MK-0524
  • Drug: Placebo for Laropiprant
    One tablet orally once daily for 4 weeks
  • Experimental: Laropiprant
    Intervention: Drug: Laropiprant
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo for Laropiprant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01451619
MK-0524-155
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP