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

Rosacea Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451619
• Other study ID #: 0524-155
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2011
• Last updated: March 24, 2015
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Laropiprant
One 100-mg tablet orally once daily for 4 weeks
• Placebo for Laropiprant
One tablet orally once daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline		Baseline and Week 4	No
Secondary	Change in Patient Self Assessment (PSA) Score from Baseline		Baseline and Week 4	No