RosaceaPhase 3NCT03954444

A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream"

A Phase 3 study testing Oxymetazoline Hydrochloride and Rhofade Cream, 1% in people with Rosacea, run by Actavis Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

A Randomized, Double-blind, Parallel-group, Three-arm, Placebo-controlled, Multi-Site Therapeutic Equivalence Study with Clinical End-points Comparing Test Product "Oxymetazoline hydrochloride Cream, 1%" to Reference Product "RHOFADE™ Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Rosacea
What is being tested?: Oxymetazoline Hydrochloride and Rhofade Cream, 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,105 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2019to 27 Feb 2020
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

(1) Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form, (or assent in applicable states/countries). In addition, study subjects must sign a HIPAA authorization, if applicable.
(2) Healthy male or non-pregnant females, ≥18 years-of-age with a clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
(3) Ability to follow study instructions and complete subject diary without assistance.
(4) Females of child bearing potential must not be pregnant or lactating at screening visit and at baseline visit, as documented by a negative urine pregnancy test.
(5) Female subjects of childbearing potential must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of Investigational Product (IP). A sterile sexual partner is NOT considered an adequate form of birth control.
(6) Moderate to severe persistent facial erythema associated with rosacea, defined as a grade of ≥3 on the CEA scale as assessed by the Investigator at Screening and on Baseline (Day 1) visit prior to study drug application.

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(7) Moderate to severe persistent facial erythema associated with rosacea, defined as a grade of ≥3 on the SSA scale as assessed by the subject at Screening and on Baseline (Day 1) visit prior to study drug application.
(8) Stable erythema (for at least 3 months prior to screening) associated with rosacea, with minimal variation from day to day and within each day, in the opinion of the subject.
(9) Willingness to complete the required visits including short stay for at least 12 hours at the investigational site for 2 separate visits.
(10) Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or sunscreens must have used the same product brands/types for a minimum period of 4 weeks prior to Baseline, must agree not to change brand/type or frequency of use throughout the study and must agree not to use make-up, facial moisturizers, creams, lotions and/or sunscreens on the scheduled clinic visit day before the visit.
(11) Subject must be willing to avoid the use of abrasive cleansers or washes (e.g., exfoliating facial scrubs), adhesive cleansing strips (e.g., Bioré® Pore Strips) and wax epilation on the face, during the entire duration of their study participation.
(12) Subject's willingness to minimize external factors that might trigger rosacea flare-ups (e.g., spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds, alcoholic beverages).
(13) Subject must be in good health and free from any systemic or dermatological disorder (other than rosacea) that, in the opinion of the Investigator, will interfere with the study evaluations or increase the risk of AEs.
(14) Any skin type or race, providing the skin pigmentation will allow discernment of erythema.

Who cannot join

(1) Any of the following conditions: severe or unstable or uncontrolled cardiovascular disease, clinically unstable hypertension, orthostatic hypotension, and uncontrolled hypertension or hypotension, cerebral or coronary insufficiency, Raynaud's Syndrome, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, renal or hepatic impairment.
(2) Subjects with narrow angle glaucoma.
(3) Females who are pregnant, breast feeding, or planning a pregnancy during the study.
(4) Females of childbearing potential who do not agree to utilize an adequate form of contraception during their participation in the study.
(5) Clinical signs of particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) on the face or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia that may interfere with the study evaluations, in the opinion of the Investigator.
(6) Presence of ≥3 facial inflammatory lesions of rosacea at screening and baseline.

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(7) Presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea, as determined by the Investigator.
(8) Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with the study treatments or study assessments.
(9) History of drug or alcohol abuse within 12 months prior to the Screening visit.
(10 Known hypersensitivity or allergies to any component of the study treatment.
(11) Use within 12 hours prior to baseline of any topical products including, but not limited to, lotions, creams, ointments, and cosmetics applied to the face (facial cleanser is acceptable).
(12) Use 1 week prior to baseline of niacin ≥500 mg/day.
(13) Use within 2 weeks prior to baseline of products containing topical corticosteroids, topical retinoids, topical antibiotics, topical anti-inflammatory, topical treatment for rosacea, or topical treatment for acne.
(14) Use within 4 weeks prior to baseline of topical immunomodulators, systemic antibiotics, systemic corticosteroids, systemic anti-inflammatory agents, systemic treatment for rosacea, or systemic treatment for acne (other than oral retinoids, which require a 6-month washout).
(15) Undergone 4 weeks prior to baseline any dermatologic or surgical procedure on the face.
(16) Use within 3 months prior to baseline of any systemic immunomodulators known to have an effect on rosacea.
(17) Use within 6 months prior to baseline of any oral retinoids (e.g., isotretinoin) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
(18) Undergone 6 months prior to baseline any laser, light-source (e.g. intense pulsed light, photodynamic therapy) or other energy-based therapy to the face.
(19) Exposed to excessive UV radiation within 1 week before Screening visit and/or subject is unwilling to refrain from excessive exposure to UV radiation during the course of the study.
(20) Current use of monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, cardiac glycosides, beta blockers, other antihypertensive agents, or oxymetazoline (e.g., eye drops, nasal sprays).
(21) Subject has participated in a clinical trial within 30 days or in a biologics study within 6 months preceding admission of this study.
(22) Previous participation in this study.
(23) Inability to communicate well (i.e., language problem, poor mental development, psychiatric illness or poor cerebral function), that may impair the ability to provide written informed consent.
(24) Subject has any evidence of organ dysfunction, chronic infectious disease, system disorder or has a condition or is in a situation that, in the Investigator's opinion, that may put the subject at significant risk, may confound the study results, or may significantly interferes with the subject's participation in the study.
(25) Employees or family members of the research center or Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Site 1
Lynchburg, Virginia, 24501

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Parallel Group, Three Arm, Placebo Controlled, Multi-Site Therapeutic Equivalence Study With Clinical End-points Comparing Test Product "Oxymetazoline Hydrochloride Cream, 1%" to Reference Product "RHOFADETM Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea

Conditions: Rosacea
Being tested: Oxymetazoline Hydrochloride, Rhofade Cream, 1%, Placebo
Medical subject headings: Rosacea

What participants receive

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

Oxymetazoline HydrochlorideDrug
Test Comparator
Rhofade Cream, 1%Drug
Also called Oxymetazoline hydrochloride
Reference Comparator
PlaceboDrug
Also called Oxymetazoline hydrochloride
Placebo Comparator

Study groups in NCT03954444
Study group	Role	What they receive
Oxymetazoline hydrochloride Cream, 1%	Active comparator	Oxymetazoline hydrochloride cream, 1% Receives: Drug: Oxymetazoline Hydrochloride
RHOFADE Cream, 1%	Active comparator	RHOFADE Cream, 1% Receives: Drug: Rhofade Cream, 1%
Vehicle Cream	Placebo comparator	Vehicle cream Receives: Drug: Placebo

What is being measured

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

Percentage of Subjects With Treatment Success at All Time Points 3, 6, 9 and 12 Hours Post-application on Day 29. Treatment Success Was Defined as Having a Clinician Erythema Assessment Score at Least 2 Grades Lower Than the Baseline (Day 1 Predose) Value
The primary efficacy endpoint was the proportion of subjects with treatment success at all time points 3, 6, 9, and 12 hours post-application on Day 29. Treatment success was defined as having CEA score at least 2 grades lower than the baseline (Day 1 pre-dose) value. Clinician Erythema Assessment was measured as (0-clear, 1-almost clear, 2-mild, 3-moderate, 4- severe).
Measured: 29 days

Timeline

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

15 Apr 201927 Feb 2020

First posted17 May 2019
Study start15 Apr 2019
Primary completion7 Jan 2020
Study completion27 Feb 2020

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03954444
Sponsor's protocol ID: OXY2018-01
Status last verified: Jun 2021
First submitted: 10 Apr 2019
Last updated: 23 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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
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All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Parallel Group, Three Arm, Placebo Controlled, Multi-Site Therapeutic Equivalence Study With Clinical End-points Comparing Test Product "Oxymetazoline Hydrochloride Cream, 1%" to Reference Product "RHOFADETM Cream, 1%" in the Treatment of Moderate to Severe Persistent Facial Erythema of Rosacea
ClinicalTrials.gov ID: NCT03954444
Acronym / sponsor ID: OXY2018-01
Conditions: Rosacea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,105 participants (actual)
Lead sponsor: Actavis Inc.Industry (pharma, biotech, devices)
Collaborators: Teva Pharmaceuticals USA
Study start: 15 Apr 2019 (actual)
Primary completion: 7 Jan 2020 (actual)
Study completion: 27 Feb 2020 (actual)
First posted: 17 May 2019 (actual)
Results: Posted 23 Jun 2021

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Oxymetazoline hydrochloride Cream, 1%	Active comparator	Drug: Oxymetazoline HydrochlorideOxymetazoline hydrochloride cream, 1%
RHOFADE Cream, 1%	Active comparator	Drug: Rhofade Cream, 1%RHOFADE Cream, 1%
Vehicle Cream	Placebo comparator	Drug: PlaceboVehicle cream

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

(1) Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form, (or assent in applicable states/countries). In addition, study subjects must sign a HIPAA authorization, if applicable.
(2) Healthy male or non-pregnant females, ≥18 years-of-age with a clinical diagnosis of rosacea with persistent (non-transient) facial erythema.
(3) Ability to follow study instructions and complete subject diary without assistance.
(4) Females of child bearing potential must not be pregnant or lactating at screening visit and at baseline visit, as documented by a negative urine pregnancy test.
(5) Female subjects of childbearing potential must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of Investigational Product (IP). A sterile sexual partner is NOT considered an adequate form of birth control.

Key exclusion criteria (25 listed)

(1) Any of the following conditions: severe or unstable or uncontrolled cardiovascular disease, clinically unstable hypertension, orthostatic hypotension, and uncontrolled hypertension or hypotension, cerebral or coronary insufficiency, Raynaud's Syndrome, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, renal or hepatic impairment.
(2) Subjects with narrow angle glaucoma.
(3) Females who are pregnant, breast feeding, or planning a pregnancy during the study.
(4) Females of childbearing potential who do not agree to utilize an adequate form of contraception during their participation in the study.
(5) Clinical signs of particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) on the face or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia that may interfere with the study evaluations, in the opinion of the Investigator.

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
Oxymetazoline HydrochlorideTest Comparator	Drug	Oxymetazoline hydrochloride Cream, 1%
Rhofade Cream, 1%Also: Oxymetazoline hydrochlorideReference Comparator	Drug	RHOFADE Cream, 1%
PlaceboAlso: Oxymetazoline hydrochloridePlacebo Comparator	Drug	Vehicle Cream

Primary outcome

Percentage of Subjects With Treatment Success at All Time Points 3, 6, 9 and 12 Hours Post-application on Day 29. Treatment Success Was Defined as Having a Clinician Erythema Assessment Score at Least 2 Grades Lower Than the Baseline (Day 1 Predose) Value
Time frame: 29 days
The primary efficacy endpoint was the proportion of subjects with treatment success at all time points 3, 6, 9, and 12 hours post-application on Day 29. Treatment success was defined as having CEA score at least 2 grades lower than the baseline (Day 1 pre-dose) value. Clinician Erythema Assessment was measured as (0-clear, 1-almost clear, 2-mild, 3-moderate, 4- severe).

Results and safety

Results posted to the registry on 23 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxymetazoline Hydrochloride Cream, 1%	379	366
RHOFADE Cream, 1%	382	366
Vehicle Cream	344	327

Primary outcome: Percentage of Subjects With Treatment Success at All Time Points 3, 6, 9 and 12 Hours Post-application on Day 29. Treatment Success Was Defined as Having a Clinician Erythema Assessment Score at Least 2 Grades Lower Than the Baseline (Day 1 Predose) Value

Time frame: 29 days. Count of participants. Unit: Participants

Measure	Oxymetazoline Hydrochloride Cream, 1% n = 349	RHOFADE Cream, 1% n = 356	Vehicle Cream n = 316
Success	78	70	51
Failure	271	286	265

Oxymetazoline Hydrochloride Cream, 1% vs RHOFADE Cream, 1%: Mean Difference (Net): 2.7 (90% CI -2.6 to 8.0)
Oxymetazoline Hydrochloride Cream, 1% vs Vehicle Cream: p = 0.04, Cochran-Mantel-Haenszel
RHOFADE Cream, 1% vs Vehicle Cream: p = 0.1126, Cochran-Mantel-Haenszel

Population analysed: Equivalence Analysis of the Primary Endpoint (Per Protocol Population)

Adverse events

Time frame: 2 month adverse event data collection. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxymetazoline Hydrochloride Cream, 1%	0 of 379 (0%)	61 of 379 (16.1%)	0 of 379
RHOFADE Cream, 1%	1 of 382 (0.3%)	60 of 382 (15.7%)	0 of 382
Vehicle Cream	1 of 344 (0.3%)	48 of 344 (14%)	0 of 344

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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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)
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Recruiting
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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 Oxymetazoline Hydrochloride and Rhofade Cream, 1% in people with Rosacea, run by Actavis Inc. 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 14 inclusion and 25 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 23 Jun 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 23 Jun 2021). 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?

Percentage of Subjects With Treatment Success at All Time Points 3, 6, 9 and 12 Hours Post-application on Day 29. Treatment Success Was Defined as Having a Clinician Erythema Assessment Score at Least 2 Grades Lower Than the Baseline (Day 1 Predose) Value (time frame: 29 days). 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 NCT03954444.

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 23 Jun 2021.