Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face

NCT02800148 | Completed Phase 3 Results

• 1 other identifier: PRG-NY-16-009
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the bioequivalence of Perrigo's azelaic acid foam product to Finacea Foam for the treatment of Inflammatory Lesions of Rosacea

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• Percent Change (Reduction) of Lesion Count From Day 1

  Day 84

Study Arms (3)

Azelaic acid foam

EXPERIMENTAL

Drug: Azelaic acid foam

Finacea Foam

ACTIVE COMPARATOR

Drug: Azelaic acid foam

Placebo Foam

PLACEBO COMPARATOR

Drug: Azelaic acid foam - Placebo

Interventions

Azelaic acid foam DRUG

Azelaic acid foam

Azelaic acid foam - Placebo DRUG

Placebo Foam

Eligibility Criteria

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

You may qualify if:

• Subject must sign an Institutional Review Board (IRB) approved written informed consent for this study.
• Subjects must be at least 18 years of age.
• Subjects must have a definite clinical diagnosis of moderate to facial papulopustular rosacea,
• Subjects must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, refrain from use of all other
• Subjects must 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 (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.

You may not qualify if:

• Subjects, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation.
• Current or past ocular rosacea
• Presence of any other facial skin condition that might interfere with rosacea diagnosis and/or assessment
• Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial or, in judgment of the Investigator, would put the subject at undue risk or might confound the study assessments
• Currently using any product containing Azelaic Acid/or belonging to the same family as Azelaic Acid foam, 15%.
• Any use of Azelaic Acid Foam, 15%, 1 month (30 days) prior to baseline or throughout the study.
• History of hypersensitivity or allergy to Finacea® (Azelaic Acid) Foam, 15%, and/or any ingredient in the study medication.
• Use of radiation therapy and/or anti-neoplastic agents within 90 days prior to Visit 1/Day 1 (Baseline).
• Current use of anticoagulation therapy and use throughout the study.
• Use of medicated make-up (including anti-aging make-up) throughout the study
• 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).
• Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics.
• Use of medicated cleansers on the face throughout the study.
• Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements
• Use of topical astringents or abrasives, medicated topical preparations (prescription and OTC products) within 2 days prior to Visit 1 and throughout the study.

Sponsors & Collaborators

• Padagis LLC: lead
• DPT Laboratories, Ltd.: collaborator

Study Sites (1)

Dermatology Consultants

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Associate Director
• 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: June 10, 2016
• First Posted: June 15, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 8, 2021
• Results First Posted: December 9, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)