A Phase 4 interventional study of Oxymetazoline HCL 1.0% Cream and Energy-Based Therapy in Rosacea, sponsored by Aclaris Therapeutics, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.
Sponsored by Aclaris Therapeutics, Inc. · Phase 4, 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 80th largest by enrollment of the 137 interventional ones that give a count, is one of 17 that started in 2017, is one of 20 in phase 4, and was the 98th 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 46 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.
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98 of 145 have an industry lead sponsor. The 10 most frequent:
Aclaris Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.
Aclaris Therapeutics, Inc. has 1 study 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:
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This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with rosacea.
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.
-Documented clinical diagnosis of rosacea.
Exclusion Criteria:
Participants will receive energy-based therapy (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) plus once daily application of oxymetazoline hydrochloride (HCl) cream 1.0%.
Drug: Oxymetazoline HCL 1.0% Cream · Device: Energy-Based Therapy
Oxymetazoline HCl cream 1.0% once daily application
Also known as: Rhofade
Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect.
Time frame: Baseline (Day 1) to Day 56
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point
The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported.
Time frame: Baseline (Day 1) to Day 56
Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point
The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported.
Time frame: Baseline (Day 1) to Day 56
| Milestone | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Started | 46 |
| Completed | 43 |
| Not completed | 3 |
| Withdrew: Adverse event | 3 |
An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect.
| Participants | Oxymetazoline + Energy-Based Therapy |
|---|---|
| TEAES | 5 |
| Treatment Emergent Serious Adverse Events | 0 |
The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported.
| Participants | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Day 1 -1 hour post dose | 8 |
| Day 3-Pre Dose | 21 |
| Day 3-1 hour post dose | 37 |
| Day 3-3 hour post dose | 42 |
| Day 3-6 hour post dose | 37 |
| Day 3 -post dose any hour | 43 |
| Day 29 Pre Dose | 18 |
| Day 29-1 hour post dose | 14 |
| Day 31 Pre Dose | 26 |
| Day 31 -1 hour post dose | 38 |
| Day 31-3 hour post dose | 39 |
| Day 31-6 hour post dose | 38 |
| Day 31 -any hour post dose | 42 |
| Day 56 -Pre Dose | 30 |
| Day 56-1 hour post dose | 30 |
| Day 56-3 hour post dose | 40 |
| Day 56 -6 hour post dose | 39 |
| Day 56 -any hour post dose | 40 |
The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported.
| Participants | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point | 3 |
Collected over Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxymetazoline + Energy-Based Therapy | 0/46 (0%) | 0/46 (0%) | 5/46 (10.9%) |
| Event | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Dermatitis ContactSkin and subcutaneous tissue disorders | 2/46 |
| Rash PustularInfections and infestations | 2/46 |
| Rash PapularSkin and subcutaneous tissue disorders | 1/46 |
| TachycardiaCardiac disorders | 1/46 |
| Face OedemaGeneral disorders | 1/46 |
| Age, Continuous(years) | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Mean | 51.1 ± 12.38 |
| Sex: Female, Male(Participants) | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Female | 36 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 43 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Oxymetazoline + Energy-Based Therapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 46 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Oxymetazoline + Energy-Based Therapy |
|---|---|
| United States | 46 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Jun 2018, 6 months.
Results were first posted in Jun 2019, 1 year after primary completion.
Of 12 phase 4 interventional studies under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxymetazoline