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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lipidome and Microbiome Profile of the Eye in Rosacea

NCT03655197

Rosacea Ocular Rosacea Cutaneous Rosacea

COMPLETED EARLY_PHASE1

Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

NCT01250457

Benign Vascular Periocular Lesions

WITHDRAWN PHASE4

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

NCT01107405

Allergic Conjunctivitis

COMPLETED PHASE2

Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability

NCT03063489

Eye Pain

COMPLETED PHASE1

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

NCT03100942

Sjogren's Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rosacea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laropiprant

Group Type EXPERIMENTAL

Laropiprant

Intervention Type DRUG

One 100-mg tablet orally once daily for 4 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo for Laropiprant

Intervention Type DRUG

One tablet orally once daily for 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laropiprant

One 100-mg tablet orally once daily for 4 weeks

Intervention Type DRUG

Placebo for Laropiprant

One tablet orally once daily for 4 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MK-0524

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No