RosaceaPhase 3NCT02800148

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

A Phase 3 study testing Azelaic acid foam in people with Rosacea, run by Padagis LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Rosacea
What is being tested?: Azelaic acid foam
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 667 participants
Where: 1 siteUnited States
Study dates: Nov 2016to Oct 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 20Show fewer

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.
Use of antipruritics (including antihistamines), spa treatments or chlorine exposure (swimming etc.) within 24 hours of all study visits.
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.
Previous enrollment in this study or current enrollment in this study at another participating site.
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.
Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dermatology Consultants
High Point, North Carolina, 27262

Other trials in United States

About this study

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

Conditions: Rosacea
Being tested: Azelaic acid foam, Azelaic acid foam - Placebo
Medical subject headings: Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Azelaic acid foamDrug
Azelaic acid foamDrug
Also called Finacea Foam
Azelaic acid foam - PlaceboDrug

Study groups in NCT02800148
Study group	Role	What they receive
Azelaic acid foam	Experimental	Not described Receives: Drug: Azelaic acid foam
Finacea Foam	Active comparator	Not described Receives: Drug: Azelaic acid foam
Placebo Foam	Placebo comparator	Not described Receives: Drug: Azelaic acid foam - Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change (Reduction) of Lesion Count From Day 1
Measured: Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Oct 2017

First posted15 Jun 2016 (estimated)
Study startNov 2016
Primary completionOct 2017
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RosaceaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 667 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02800148
Sponsor's protocol ID: PRG-NY-16-009
Status last verified: Nov 2021
First submitted: 10 Jun 2016
Last updated: 8 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
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RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence Study of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea on the Face
ClinicalTrials.gov ID: NCT02800148
Acronym / sponsor ID: PRG-NY-16-009
Conditions: Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 667 participants (actual)
Lead sponsor: Padagis LLCIndustry (pharma, biotech, devices)
Collaborators: DPT Laboratories, Ltd.
Study start: Nov 2016 (actual)
Primary completion: Oct 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 15 Jun 2016 (estimated)
Results: Posted 9 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (20 listed)

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%.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Azelaic acid foam	Drug	Azelaic acid foam
Azelaic acid foamAlso: Finacea Foam	Drug	Finacea Foam
Azelaic acid foam - Placebo	Drug	Placebo Foam

Primary outcome

Percent Change (Reduction) of Lesion Count From Day 1
Time frame: Day 84

Results and safety

Results posted to the registry on 9 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azelaic Acid Foam	224	199
Finacea Foam	224	204
Placebo Foam	219	194

Primary outcome: Percent Change (Reduction) of Lesion Count From Day 1

Time frame: Day 84. Mean (Standard Deviation). Unit: percentage of lesion reduction

Measure	Azelaic Acid Foam n = 178	Finacea Foam n = 181	Placebo Foam n = 178
Value	61.14 (33.623)	57.27 (34.513)	49.43 (44.437)

Azelaic Acid Foam vs Finacea Foam: equivalence ratio: 107 (90% CI 96.1 to 115.5), Fieller's method

Adverse events

Time frame: 84 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azelaic Acid Foam	1 of 224 (0.4%)	0 of 224 (0%)	0 of 224
Finacea Foam	0 of 224 (0%)	0 of 224 (0%)	0 of 224
Placebo Foam	2 of 219 (0.9%)	0 of 219 (0%)	0 of 219

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Rosacea

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
Rosacea, Vascular Diseases
RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
Determinants of Chronic Inflammatory Skin Disease Trajectories
Atopic Dermatitis, Psoriasis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azelaic acid foam in people with Rosacea, run by Padagis LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change (Reduction) of Lesion Count From Day 1 (time frame: Day 84). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02800148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.