Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea

NCT03380390 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: CMO-MA-MED-0530
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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%.

Drug: Oxymetazoline HCL 1.0% Cream; Device: Energy-Based Therapy

Interventions

Oxymetazoline HCL 1.0% Cream DRUG

Oxymetazoline HCl cream 1.0% once daily application

Also known as: Rhofade

Oxymetazoline + Energy-Based Therapy

Energy-Based Therapy DEVICE

Energy-based therapies (Potassium Titanyl Phosphate \[KTP\], Pulsed Dye Laser \[PDL\], or Intense Pulsed Light \[IPL\])

Oxymetazoline + Energy-Based Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented clinical diagnosis of rosacea.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (4)

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Skin Laser and Surgery Specialists of NY/NJ

Hackensack, New Jersey, 07601, United States

Location

Laser & Skin Surgery Center of New York Professional Corporation

New York, New York, 10016, United States

Location

Related Links

• More Information

MeSH Terms

Conditions

Rosacea

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David Gordon
• Organization: Aclaris Therapeutics

dgordon@aclaristx.com

484-540-6273

Study Officials

• Nancy Alvandi

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: December 4, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: September 4, 2019
• Results First Posted: June 28, 2019

Record last verified: 2018-06

Locations

US (4)