BioequivalencePhase 1NCT05148689
A Study Comparing Oxymetazoline 1% Cream to RHOFADE
A Phase 1 study testing Oxymetazoline hydrochloride Cream, 1% and Rhofade™ (oxymetazoline) cream, 1% in people with Bioequivalence, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
randomized, double-blind, placebo controlled Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Oxymetazoline hydrochloride Cream, 1% and Rhofade™ (oxymetazoline) cream, 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 31 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;
- Provided IRB approved written informed consent;
- A CEA score of ≥3 prior to study drug application
- A PSA score of ≥3 prior to study drug application
Who cannot join
- Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;
- History of hypersensitivity to the study product;
- Presence of ≥3 facial inflammatory lesions of rosacea;
- Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);
- Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;
- Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments;
- Presence of significant hypertension or circulatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo Controlled Study, Comparing Oxymetazoline 1% Cream TO RHOFADE in the Treatment of Moderate to Severe Persistent Facial Erythema Assocoated With Rosacea
randomized, double-blind, placebo controlled
Read the detailed description
Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.
- Conditions
- Bioequivalence
- Being tested
- Oxymetazoline hydrochloride Cream, 1%, Rhofade™ (oxymetazoline) cream, 1%, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline hydrochloride Cream, 1%Drug
Also called Oxymetazoline
Cream
Rhofade™ (oxymetazoline) cream, 1%Drug
cream
PlaceboDrug
cream
| Study group | Role | What they receive |
|---|---|---|
| test product | Experimental | Oxymetazoline Cream, 1% Receives: Drug: Oxymetazoline hydrochloride Cream, 1% |
| reference | Active comparator | Rhofade™ (oxymetazoline) cream, 1% Receives: Drug: Rhofade™ (oxymetazoline) cream, 1% |
| placebo | Placebo comparator | Vehicle of Test product Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
erythema response success
at least a 2-grade improvement in both CEA and PSA
Measured: 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start23 Feb 2018
- Primary completion21 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kelly Walker, Study chair, WayCro / Trial Clinsultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148689
- Sponsor's protocol ID
- XMTC-1810
- Status last verified
- Dec 2021
- First submitted
- 23 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo Controlled Study, Comparing Oxymetazoline 1% Cream TO RHOFADE in the Treatment of Moderate to Severe Persistent Facial Erythema Assocoated With Rosacea
- ClinicalTrials.gov ID
- NCT05148689
- Acronym / sponsor ID
- XMTC-1810
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
randomized, double-blind, placebo controlled
Detailed description
Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test product | Experimental | Drug: Oxymetazoline hydrochloride Cream, 1%Oxymetazoline Cream, 1% |
| reference | Active comparator | Drug: Rhofade™ (oxymetazoline) cream, 1%Rhofade™ (oxymetazoline) cream, 1% |
| placebo | Placebo comparator | Drug: PlaceboVehicle of Test product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;
- Provided IRB approved written informed consent;
- A CEA score of ≥3 prior to study drug application
- A PSA score of ≥3 prior to study drug application
Key exclusion criteria (7 listed)
- Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;
- History of hypersensitivity to the study product;
- Presence of ≥3 facial inflammatory lesions of rosacea;
- Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);
- Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;
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 hydrochloride Cream, 1%Also: OxymetazolineCream | Drug | test product |
| Rhofade™ (oxymetazoline) cream, 1%cream | Drug | reference |
| Placebocream | Drug | placebo |
Primary outcome
erythema response success
Time frame: 21 day
at least a 2-grade improvement in both CEA and PSA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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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.
Kelly Walker study chair
WayCro / Trial Clinsultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxymetazoline hydrochloride Cream, 1% and Rhofade™ (oxymetazoline) cream, 1% in people with Bioequivalence, run by Sun Pharmaceutical Industries, 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 4 inclusion and 7 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 Dec 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
erythema response success (time frame: 21 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2021.