A Phase 3 interventional study of Oxymetazoline in Rosacea and Erythema, sponsored by Padagis LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-08.
Sponsored by Padagis LLC · Phase 3, Interventional, and Treatment
Among 145 studies in Rosacea with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Rosacea · United States.
Among the 145 studies in Rosacea with a site in United States, this one is the 77th largest by enrollment of the 137 interventional ones that give a count, is one of 17 that started in 2017, is one of 32 in phase 3, and was the 95th registered.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
Browse Rosacea studies →8 of the 145 studies in Rosacea with a site in United States are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Bulgaria, Canada and 6 more countries
Ages 18+
Brigham and Women's Hospital · Sites in United States
Ages 18+
Narrows Institute for Biomedical Research · Sites in United States
Ages 18+ · Healthy volunteers
University of Miami · Sites in United States
Ages 18+
Wright State University · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 17 Rosacea studies recruiting now, 9 (53%) set no upper age limit and 7 (41%) stop at 75 or younger; 1 takes children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
145 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 44 · Phase 3 34 · Phase 4 20
First in 2002; this study’s year is marked. 17 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 50 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Median enrollment 78 across the 137 interventional studies, 236 across the 8 observational. Of the 127 that completed or were terminated, 76 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
98 of 145 have an industry lead sponsor. The 10 most frequent:
Padagis LLC is the lead sponsor of 37 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Padagis LLC has 4 studies filed under Rosacea — fewer than ten, so there is no comparison to draw.
3 of the studies in Rosacea with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07443202Tarsus Pharmaceuticals, Inc.Study of Lotilaner Ophthalmic Gel in Patients With Ocular Rosacea (KORE) | 2026-12-31 |
| NCT06801717University of MiamiRosacea Radiofrequency Microneedling | 2027-07-01 |
| NCT04108897Johns Hopkins UniversityAnalysis of the Microbiome in Rosacea | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 145 studies in Rosacea with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
the study will measure the decrease in redness on the face of rosacea subjects
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Oxymetazoline
RLD
Responder
Responder is defined as a 2-grade improvement from pre-dose on Day 1 on both the Clinician Erythema Assessment and Patient Self Assessment scales
Time frame: Day 15
| Milestone | Oxymetazoline Cream |
|---|---|
| Started | 50 |
| Completed | 49 |
| Not completed | 1 |
Responder is defined as a 2-grade improvement from pre-dose on Day 1 on both the Clinician Erythema Assessment and Patient Self Assessment scales
| percentage of responders | Oxymetazoline Cream |
|---|---|
| Responder | 16.7 |
Collected over 15 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxymetazoline Cream | 0/50 (0%) | 0/50 (0%) | 3/50 (6%) |
| Event | Oxymetazoline Cream |
|---|---|
| HeadacheNervous system disorders | 3/50 |
| Age, Categorical(Participants) | Oxymetazoline Cream |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 36 |
| >=65 years | 14 |
| Age, Continuous(years) | Oxymetazoline Cream |
|---|---|
| Mean | 51.5 ± 15.36 |
| Sex: Female, Male(Participants) | Oxymetazoline Cream |
|---|---|
| Female | 42 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Oxymetazoline Cream |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 45 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Oxymetazoline Cream |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 50 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Dec 2017, 1 month.
Results were first posted in Jan 2021, 3 years after primary completion. A results delay was requested in Jan 2019.
Of 17 phase 3 interventional studies under Rosacea, half reached primary completion within 11 months of starting (the median); a quarter within 9 and three quarters within 15. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Oxymetazoline