COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02795117
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Perrigo Company

Brief Summary:
The purpose of this study is to compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of inflammatory lesions rosacea

Condition or disease Intervention/treatment Phase
Rosacea Drug: Ivermectin Drug: Ivermectin (reference) Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Test product Drug: Ivermectin
Active Comparator: Reference product Drug: Ivermectin (reference)
Placebo Comparator: Placebo product Drug: Placebo

Primary Outcome Measures :
  1. Mean percent change from baseline in the inflammatory (papules and pustules) lesion count [ Time Frame: Day 84 ]

Secondary Outcome Measures :
  1. Subjects with clinical success on the Investigator Global Assessment (IGA) [ Time Frame: Day 84 ]
    Clinical success is defined as a score of clear or almost clear (score of 0 or 1)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Must sign an Institutional Review Board (IRB) approved written informed consent for this study.
  2. Must be at least 18 years of age
  3. Must have a definite clinical diagnosis of moderate to severe facial papulopustular rosacea
  4. Subjects must be willing and able to understand and comply with the requirements of the study and apply the medication as instructed.
  5. Subjects must be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
  6. Females of childbearing potential (excluding women who are surgically sterilized (verified tubal ligation or bilateral oophorectomy or hysterectomy) or post- menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1 (Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

  1. Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
  2. Current or past ocular rosacea.
  3. Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment.
  4. History of hypersensitivity or allergy to the study medication and/or any ingredient in the study medication.
  5. Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
  6. Current use of anticoagulation therapy and use throughout the study.
  7. Use of medicated make-up (including anti-aging make-up) throughout the study
  8. Use during the study of 1) systemic steroids, 2) topical retinoids to the face 3) antibiotics known to impact rosacea 4) immunosuppressive agents, or immunomodulators).
  9. Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.
  10. Use of medicated cleansers on the face (throughout the study.
  11. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
  12. Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.
  13. Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.
  14. Participation in any clinical study involving an investigational product, agent or device that might influence the intended effects or mask the side effects of study medication in the 1 month (30 days) prior Visit 1/Day 1 (Baseline) or throughout the study.
  15. Previous enrollment in this study or current enrollment in this study at another participating site.
  16. Use of tanning booths, sun lamps (excessive UV radiation e.g., phototherapy, daily extended exposure or occupational exposure to the sun), sunbathing or excessive exposure to the sun 1 week prior to baseline and throughout the study.
  17. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
Layout table for additonal information
Responsible Party: Perrigo Company Identifier: NCT02795117    
Other Study ID Numbers: PRG-NY-15-013
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Diseases
Antiparasitic Agents
Anti-Infective Agents