Status:
COMPLETED
A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01451619
Start Date
November 1 2011
End Date
April 1 2012
Last Update
March 25 2015
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