RosaceaPhase 1NCT01451619
A Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155)
A Phase 1 study testing Laropiprant in people with Rosacea, run by Merck Sharp & Dohme LLC.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea
- What is being tested?
- Laropiprant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
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)
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
- Being tested
- Laropiprant, Placebo for Laropiprant
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaropiprantDrug
Also called MK-0524
One 100-mg tablet orally once daily for 4 weeks
Placebo for LaropiprantDrug
One tablet orally once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Laropiprant | Experimental | Not described Receives: Drug: Laropiprant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo for Laropiprant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline
Measured: Baseline and Week 4
Secondary outcomes (1)
Change in Patient Self Assessment (PSA) Score from Baseline
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451619
- Sponsor's protocol ID
- 0524-155
- Status last verified
- Mar 2015
- First submitted
- 11 Oct 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25142778
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01451619
- Acronym / sponsor ID
- 0524-155
- Conditions
- Rosacea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laropiprant | Experimental | Drug: Laropiprant |
| Placebo | Placebo comparator | Drug: Placebo for Laropiprant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaropiprantAlso: MK-0524One 100-mg tablet orally once daily for 4 weeks | Drug | Laropiprant |
| Placebo for LaropiprantOne tablet orally once daily for 4 weeks | Drug | Placebo |
Primary outcome
Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline
Time frame: Baseline and Week 4
1 secondary outcome
Change in Patient Self Assessment (PSA) Score from Baseline
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Results publication: PubMed 25142778Krishna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laropiprant in people with Rosacea, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01451619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.