NCT04519723

Laser 360iQ: Optimal Light-laser Combination Therapy

Laser 360iQ: Optimal Light-laser Combination Therapy for the Improvement of Skin Color, Tone, Texture and Laxity.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Alma Lasers Inc. · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To assess the safety and efficacy of light-laser combination therapy for the improvement of skin color, tone, texture and laxity

Detailed description

This is a prospective study to test the safety and efficacy of a three different light and laser handpieces for the improvement of skin color, tone, texture and laxity. All subjects will receive up to four treatments, administered in intervals of 28 +/- 2 days. Each full face treatment duration will be approximately 60 minutes. The initial power and number of passes parameters shall be set according to the clinical indication and skin type of the subject treated. The treatment area will be cleaned and photographed before each treatment. Photographs will be taken at baseline, prior to each treatment and during each follow-up visit. Before the initiation of the first treatment each subject will undergo clinical evaluation. Clinical improvement will be assessed by the investigator from the visual appearance of the treated area and from the fixed magnification clinical photographs according to the following scale: -1 for exacerbation, 0 no change, 1 for 1%-25% improvement, 2 for 25%-50% improvement, 3 for 50%-75% improvement, and 4 for 75%-99% improvement. Adverse side effects will be scored by clinical evaluation of erythema, edema, and burns. Treatments and results will be documented in a Case Report Form at each treatment session and follow-up session (1 month and 3 months after the last treatment). In case of adverse side effects and symptoms other than erythema or edema appear during or following a treatment, the next treatment may be skipped by two weeks or treatment parameters reduced until symptoms resolve. If adverse side effects are observed, the investigator should provide the subject with the proper care and remedy and will document it in the Case Report Form.

Conditions

• Photodamage

Interventions

Type	Name	Description
DEVICE	Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2020-08-20
• Last updated: 2020-08-20

Locations

1 site across 1 country: United States