---
title: A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155)
nct_id: NCT01451619
overall_status: COMPLETED
phase: PHASE1
sponsor: Merck Sharp & Dohme LLC
study_type: INTERVENTIONAL
primary_condition: Rosacea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01451619.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01451619"
ct_last_update_post_date: 2015-03-25
last_seen_at: "2026-05-12T06:30:37.913Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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)

**NCT ID:** [NCT01451619](https://clinicaltrials.gov/study/NCT01451619)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Rosacea
- **Start Date:** 2011-11
- **Completion Date:** 2012-04
- **CT.gov Last Update:** 2015-03-25

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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
```

## Arms

- **Laropiprant** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Laropiprant** (DRUG) — One 100-mg tablet orally once daily for 4 weeks
- **Placebo for Laropiprant** (DRUG) — One tablet orally once daily for 4 weeks

## Primary Outcomes

- **Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline** _(time frame: Baseline and Week 4)_

## Secondary Outcomes

- **Change in Patient Self Assessment (PSA) Score from Baseline** _(time frame: Baseline and Week 4)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01451619.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01451619*  
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