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

NCT01451619 | Completed Phase 1

• 1 other identifier: 0524-155
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline

  Baseline and Week 4

Secondary Outcomes (1)

• Change in Patient Self Assessment (PSA) Score from Baseline

  Baseline and Week 4

Study Arms (2)

Laropiprant

EXPERIMENTAL

Drug: Laropiprant

Placebo

PLACEBO COMPARATOR

Drug: Placebo for Laropiprant

Interventions

Laropiprant DRUG

One 100-mg tablet orally once daily for 4 weeks

Also known as: MK-0524

Laropiprant

Placebo for Laropiprant DRUG

One tablet orally once daily for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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. J Clin Pharmacol. 2015 Feb;55(2):137-43. doi: 10.1002/jcph.383. Epub 2014 Sep 4.

  PMID: 25142778 RESULT

MeSH Terms

Conditions

Rosacea

Interventions

MK-0524

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 13, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 25, 2015

Record last verified: 2015-03