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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Rosacea

Treatments

Drug: Placebo for Laropiprant

Drug: Laropiprant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01451619

0524-155

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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