EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA

Rosacea Clinical Trial

Official title:

EVALUATION OF THE EFFECT OF THE PERFECTA V-BEAM LASER ON ROSACEA (FACIAL REDNESS, TELANGIECTASIAS AND PHOTODAMAGE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03211585
• Other study ID #: 2016-01
• Status: Active, not recruiting
• Phase: N/A
• First received: July 5, 2017
• Last updated: July 9, 2017
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to further quantify the safety and effectiveness of the Syneron-Candela long pulse-duration, extended sub-pulse, larger spot-size prototype Perfecta V-Beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. The Perfecta laser system is expected to provide effective treatment of rosacea with less bruising or purpura and greater effectiveness than previous generation systems. This study should enable optimization of treatment parameters for using the Perfecta 595nm laser for treating rosacea.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects must have a Fitzpatrick skin type of I-IV and have Rosacea as evaluated by the treating physician.

• Subjects must have visible telangiectasia on the side of the face.

• Subjects must be willing and able to comply with all follow-up requirements.

• Subjects must be willing and able to apply sunblock SPF of 30 while exposed to the sun.

• Subject willing to have photographs taken and used in presentations or publications.

Exclusion Criteria:

• Subjects must not have had a previous laser treatment, deep chemical peel in the intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6 months of their inclusion into this study or have ever taken gold therapy.

• Subjects must not have a history of keloid formation.

• Subjects with Fitzpatrick Classification of V or VI (to reduce the risk of hyper-pigmentation).

• Subjects must be willing and able to comply with all follow-up requirements.

• Subjects cannot have vitiligo, a condition where pigment is lost in the skin and white patches appear).

• Subjects not willing to avoid sun exposure or not will to apply sunblock SPF of 30 while exposed to the sun.

• Subject not willing to have photographs taken and used in presentations, publications and marketing material

Related Conditions & MeSH terms

• Rosacea

Intervention

Device:
• Perfecta V-Beam laser
This s a single study and a prototype of the FDA-cleared, flashlamp-pumped pulsed-dye laser, that is currently on the market, that has evolved over almost 25 years of continuous development. The broad-spectrum flashlamp pumps energy into a cavity containing liquid dye. The dye is excited resulting in the emission of 595 nm orange light.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage reduction in the facial redness and telangiectasias of rosacea	The percentage reduction in the facial redness and telangiectasias of rosacea will be determined by the investigators using polarized photography for each subject	two months following the final treatment