Rosacea
Conditions
Brief summary
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.
Interventions
DRUGOxymetazoline HCL 1.0% Cream
Oxymetazoline HCl cream 1.0% once daily application
DEVICEEnergy-Based Therapy
Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Documented clinical diagnosis of rosacea.
Exclusion criteria
* History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled cardiovascular disease, or any other current uncontrolled systemic disease * Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or chronic recurring facial acne * Current treatment with monoamine oxidase (MAO) inhibitors * Current treatment with niacin ≥ 500 mg/day * Greater than 3 inflammatory lesions on the face * History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Baseline (Day 1) to Day 56 | 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. |
| Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Baseline (Day 1) to Day 56 | 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. |
| Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point | Baseline (Day 1) to Day 56 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxymetazoline + Energy-Based Therapy 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%.
Oxymetazoline HCL 1.0% Cream: Oxymetazoline HCl cream 1.0% once daily application
Energy-Based Therapy: Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\]) | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
Baseline characteristics
| Characteristic | Oxymetazoline + Energy-Based Therapy |
|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 12.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 46 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 5 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
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
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | TEAES | 5 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Treatment Emergent Serious Adverse Events | 0 Participants |
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 1 -1 hour post dose | 8 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 3-Pre Dose | 21 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 3-1 hour post dose | 37 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 3-3 hour post dose | 42 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 3-6 hour post dose | 37 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 3 -post dose any hour | 43 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 29 Pre Dose | 18 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 29-1 hour post dose | 14 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 31 Pre Dose | 26 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 31 -1 hour post dose | 38 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 31-3 hour post dose | 39 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 31-6 hour post dose | 38 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 31 -any hour post dose | 42 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 56 -Pre Dose | 30 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 56-1 hour post dose | 30 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 56-3 hour post dose | 40 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 56 -6 hour post dose | 39 Participants |
| Oxymetazoline + Energy-Based Therapy | Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point | Day 56 -any hour post dose | 40 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_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 Participants |