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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxymetazoline + Energy-Based Therapy | Experimental | 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%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxymetazoline HCL 1.0% Cream | Drug | Oxymetazoline HCl cream 1.0% once daily application |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline (Day 1) to Day 56 |
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Inclusion Criteria:
-Documented clinical diagnosis of rosacea.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Alvandi | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | United States | ||
| SkinCare Physicians |
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| Label | URL |
|---|---|
| More Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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]) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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]) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Population | Posted | Count of Participants | Participants | Baseline (Day 1) to Day 56 |
|
Adverse events were collected from the time the subject signed the informed consent through Day 56 (Exit Visit)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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]) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Gordon | Aclaris Therapeutics | 484-540-6273 | dgordon@aclaristx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2018 | May 28, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 6, 2018 | May 31, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Energy-Based Therapy | Device | Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL]) |
|
| Chestnut Hill |
| Massachusetts |
| 02467 |
| United States |
| Skin Laser and Surgery Specialists of NY/NJ | Hackensack | New Jersey | 07601 | United States |
| Laser & Skin Surgery Center of New York Professional Corporation | New York | New York | 10016 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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]) |
|
|
| 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. | Posted | Count of Participants | Participants | Baseline (Day 1) to Day 56 |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline (Day 1) to Day 56 |
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| 0 |
| 46 |
| 0 |
| 46 |
| 5 |
| 46 |
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Rash Pustular | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Face Oedema | General disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Title | Measurements |
|---|---|
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| Day 3-3 hour post dose |
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| Day 3-6 hour post dose |
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| Day 3 -post dose any hour |
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| Day 29 Pre Dose |
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| Day 29-1 hour post dose |
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| Day 31 Pre Dose |
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| Day 31 -1 hour post dose |
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| Day 31-3 hour post dose |
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| Day 31-6 hour post dose |
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| Day 31 -any hour post dose |
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| Day 56 -Pre Dose |
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| Day 56-1 hour post dose |
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| Day 56-3 hour post dose |
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| Day 56 -6 hour post dose |
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| Day 56 -any hour post dose |
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