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

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

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Placebo; Drug: Ivermectin; Drug: Ivermectin (reference)

• Study Type: Interventional
• Enrollment (Actual): 486
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count	Day 1 to Day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With Clinical Success on the Investigator Global Assessment	Clinical success is defined as a score of clear or almost clear	Day 1 to Day 84

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: PRG-NY-15-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No