Clinical trial NCT01451619: A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rosacea
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change in Patient Self Assessment (PSA) Score from Baseline
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
Study officials:
References:
citation: Krishna R, Guo Y, Schulz V, Cord-Cruz E, Smith S, Hair S, Nahm WK, Draelos ZD. Non-obligatory role of prostaglandin D2 receptor subtype 1 in rosacea: laropiprant in comparison to a placebo did not alleviate the symptoms of erythematoelangiectaic rosacea. J Clin Pharmacol. 2015 Feb;55(2):137-43. doi: 10.1002/jcph.383. Epub 2014 Sep 4.