Comparative Safety and Efficacy of Two Rosacea Products in the Treatment of Facial Erythema of Rosacea

NCT02385240 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-14-022
• Study Type: interventional
• Target: 552
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare safety and efficacy of Perrigo's rosacea drug product compared to an FDA approved rosacea drug product in the treatment of facial erythema of rosacea.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Composite Success

  2-grade improvement on both the Clinician's Erythema Assessment (CEA) and the Patient Self Assessment (PSA) scales

  Day 15 at hour 6

Secondary Outcomes (2)

• Proportion of Subjects With Composite Success

  Day 15 at hour 3

• Proportion of Subjects With Composite Success

  Day 15 at hour 9

Study Arms (3)

Test product

EXPERIMENTAL

Brimonidine Topical Gel, 0.33 percent

Drug: Brimonidine Topical Gel, 0.33 percent (Perrigo)

Reference Product

ACTIVE COMPARATOR

Brimonidine Topical Gel, 0.33 percent (Reference)

Drug: Brimonidine Topical Gel, 0.33 percent (Reference)

Placebo gel

PLACEBO COMPARATOR

Placebo

Drug: Placebo gel

Interventions

Brimonidine Topical Gel, 0.33 percent (Perrigo) DRUG

Also known as: Perrigo product

Test product

Brimonidine Topical Gel, 0.33 percent (Reference) DRUG

Also known as: Reference Listed Drug Product

Reference Product

Placebo gel DRUG

Placebo gel

Eligibility Criteria

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

You may qualify if:

• Provide IRB approved written informed consent/assent.
• Male or non-pregnant female, ≥ 18 years of age.
• Diagnosis of rosacea with moderate to severe erythema on the face defined as: a score of ≥ 3 on the Clinician's Erythema Assessment (CEA) and a score of ≥ 3 on the Patient's Self-Assessment (PSA) on Visit 1/Day 1 (Baseline) prior to the first application of study medication at hour 0.
• Willing and able to understand and comply with the requirements of the study.
• Be in general good health and free from any clinically significant disease, other than rosacea, that might interfere with the study evaluations.
• Females of childbearing potential in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study

You may not qualify if:

• Females who are pregnant, breast feeding, or planning a pregnancy within the study participation period.
• Presence of three (3) or more facial inflammatory lesions of rosacea.
• Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome or depression.
• Other facial conditions that in the Investigator's opinion might interfere with a rosacea diagnosis and/or assessment including but not limited to: acne conglobata, acne fulminans, rhinophyma, facial pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, actinic keratosis, acne, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis .
• Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in the judgment of the Investigator, would put the subject at undue risk or might confound the study assessments (such as planned hospitalization during the study).
• Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
• Excessive facial hair (such as beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of rosacea.
• History of hypersensitivity or allergy to any ingredient in the study medication.
• Previous enrollment in this study.
• Non-responders to prior treatment with topical brimonidine.
• Currently using any product containing brimonidine tartrate or oxymetazoline.
• Start or change of dose of hormonal treatments.
• Start or change of dose of tricyclic or tetracyclic antidepressants, cardio glycosides, beta blockers or calcium channel blockers or other anti-hypertensive agents 3 months (90 days) prior to baseline or throughout the study. Use of such therapy must remain constant during the study.
• Current treatment with or start of any of the following class of drugs: monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics or alpha-agonists, medicines for psychosis, medicines for hyperactivity
• Use within 6 months (180 days) prior to baseline or during the study of oral retinoids or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).

Sponsors & Collaborators

• Padagis LLC: lead

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jonathan Schwartz
• Organization: Perrigo

jonathan.schwartz@perrigo.com

718-960-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 11, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 22, 2021
• Results First Posted: December 14, 2020

Record last verified: 2021-10