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

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT01451619

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:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

Further study details as provided by Merck:

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
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 May 23, 2012