Rosacea
Conditions
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.
Interventions
DRUGLaropiprant
One 100-mg tablet orally once daily for 4 weeks
DRUGPlacebo for Laropiprant
One tablet orally once daily for 4 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline | Baseline and Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Patient Self Assessment (PSA) Score from Baseline | Baseline and Week 4 |
Outcome results
None listed