Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03380390|
Recruitment Status : Completed
First Posted : December 21, 2017
Results First Posted : June 28, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rosacea||Drug: Oxymetazoline HCL 1.0% Cream Device: Energy-Based Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-Label, Interventional Study on the Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Subjects With Rosacea|
|Actual Study Start Date :||December 4, 2017|
|Actual Primary Completion Date :||June 15, 2018|
|Actual Study Completion Date :||June 15, 2018|
Experimental: 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%.
Drug: Oxymetazoline HCL 1.0% Cream
Oxymetazoline HCl cream 1.0% once daily application
Other Name: Rhofade
Device: Energy-Based Therapy
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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380390
|United States, California|
|Center for Dermatology and Laser Surgery|
|Sacramento, California, United States, 95819|
|United States, Massachusetts|
|Chestnut Hill, Massachusetts, United States, 02467|
|United States, New Jersey|
|Skin Laser and Surgery Specialists of NY/NJ|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|Laser & Skin Surgery Center of New York Professional Corporation|
|New York, New York, United States, 10016|
|Study Director:||Nancy Alvandi||Allergan|