CompletedPhase 3

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

United States667 participantsStarted 2016-11

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change (Reduction) of Lesion Count From Day 1

Timeframe: Day 84

Trial details

NCT IDNCT02800148

SponsorPadagis LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-10

Results submitted2020-10-16

View on ClinicalTrials.gov More Rosacea trials