A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (Ivermectin) Cream 1% (Galderma) in the Treatment of Moderate to Severe Papulopustular Rosacea

Actavis Inc.1 site in 1 country630 target enrollmentJune 2016

ConditionsModerate to Severe Papulopustular Rosacea

InterventionsIvermectin Cream, 1%Placebo/Vehicle cream

DrugsIvermectin Cream, 1%Placebo/Vehicle cream

Overview

Phase: Phase 3
Intervention: Ivermectin Cream, 1%
Conditions: Moderate to Severe Papulopustular Rosacea
Sponsor: Actavis Inc.
Enrollment: 630
Locations: 1
Primary Endpoint: Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of moderate to severe papulopustular rosacea.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

December 2016

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Actavis Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed Informed Consent that meets all criteria of current FDA regulations.
•Healthy male or non-pregnant, non-lactating female greater than or equal to 8 years of age with a clinical diagnosis of moderate to severe papulopustular rosacea, defined as the presence of:
•A total of 8 to 50 combined papules/pustules on the face, AND At least moderate erythema, AND Telangiectasia
•Patient has a baseline Investigator's Global Evaluation (IGE) score of 3 (moderate) or 4 (severe) for rosacea severity (See Appendix A).
•Females of child bearing potential must not be pregnant or lactating at Screening (as confirmed by a negative urine pregnancy test with a sensitivity of less than 25 mlU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception (e.g., total abstinence, IUD, a double-barrier method \[such as condom plus diaphragm with spermicide\], oral, transdermal, injected or implanted non- or hormonal contraceptive), throughout the study. If the female is using a hormonal contraceptive, the same product must be taken for 3 months prior to Visit 1 and must agree not to replace with some other hormonal contraceptives during the study. A sterile sexual partner is not considered an adequate form of birth control.
•All females will be considered to be of childbearing potential unless they: Are post-menopausal, defined as women who have been amenorrheic for at least 12 consecutive months, without other known or suspected primary cause.
•Have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy) with surgery at least 4 weeks before Screening. Tubal ligation will not be considered a surgically sterile method.
•Female patients of childbearing potential are defined as Women without prior hysterectomy of at least 4 weeks, or who have had any evidence of menses in the past 12 months.
•Females who have been amenorrhea for more than or equal to 12 months, but the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.
•Free from any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events.

Exclusion Criteria

•Females who are pregnant, lactating or planning to become pregnant during the study period.
•Patient has mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions).
•Patient has mild erythema.
•Patient has a baseline IGE score of 0, 1 or
•Patient has a skin condition on the face that would interfere with the diagnosis or assessment of rosacea (e.g., dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis).
•Patients with excessive facial hair, such as beards, sideburns, moustaches, etc., that would interfere with diagnosis or assessment of rosacea.
•Patients with tattoos or excessive facial scarring that, in the Investigator's opinion, may interfere with the evaluation of the patient's rosacea.
•Patients with active facial sunburn, peeling from sunburn, or patients that will be exposed to excessive sunlight during the study.
•Patient has significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participation.
•Any patient (male or female) who has started, or changed hormonal therapy within 3 months of the baseline visit (this includes hormonal contraceptives). Patients who have been on stable hormone therapy for at least 3 months and whose therapy is considered unlikely to be changed for the duration of the study will be eligible.

Arms & Interventions

Ivermectin Cream, 1%

test product, manufactured by Actavis Laboratories UT, Inc.

Intervention: Ivermectin Cream, 1%

SoolantraTM (ivermectin) Cream, 1%

reference product, manufactured by Galderma Laboratories, L.P.

Intervention: Ivermectin Cream, 1%

Placebo/Vehicle cream

Placebo, manufactured by Actavis Laboratories UT, Inc.

Intervention: Placebo/Vehicle cream

Outcomes

Primary Outcomes

Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea.

Time Frame: Baseline and 12 Weeks

Bioequivalence of the test to reference was considered to have been demonstrated if the 90% confidence interval for the test to reference ratio for the percent change from baseline to Week 12 in the number of inflamed lesion counts was within \[80%, 125%\].