Clinical Trials Logo
  1. Home
  2. Laser Therapy
  3. NCT01403597

Evaluation of Non-ablative and Fractional Combination Treatment for Improvement in Skin's Appearance

Laser Therapy Clinical Trial

Official title:
Clinical Evaluation of the Impact of Non-ablative and Fractional Ablative Combination Treatment: a Prospective, Open Label, Single Group With Before-after Study Design

Clinical Trial Summary

The study is designed to determine the safety, efficacy, patient comfort and patient satisfaction of the combined treatment of Refirme ST and Matrix RF both devices approved under 510k clearances. The evaluations will include skin condition, physician/subject improvement assessment, and subject comfort and satisfaction score by questionnaires.

Clinical Trial Description

The Refirme ST and the Matrix RF applicators are both FDA approved devices indicated for improvement of skin appearance. The Matrix RF applicator has FDA clearance for ablation, resurfacing of the skin, and for wrinkles treatment, whereas the Refirme-ST applicator has FDA clearance for non-invasive wrinkles treatment. The combined treatment of Refirme ST and Matrix RF is intended to improve skin appearance both by enhancement of collagen production as the result of the Refirme ST primary heating of the treated area and by causing ablation and resurfacing of the skin with the Matrix RF. In the current clinical setting, each applicator is used in a separate session although there is no contra-indication preventing the usage of these applicators in the same treatment session. A combined treatment in one session is believed to be more efficient and will be more time effective for the patient and therefore will have a commercial benefit for the manufacturer. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01403597
Study type Interventional
Source Syneron Medical
Contact
Status Completed
Phase N/A
Start date January 2011
Completion date July 2012
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A
Completed NCT00970671 - Treatment of Surgical Scars Using the Pulsed Dye Laser N/A
Completed NCT05096936 - Pilates Method and/or Photobiomodulation in Women With Stress Urinary Incontinence N/A
Completed NCT03888703 - The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation N/A
Completed NCT03086265 - Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Laser Laryngeal Surgery N/A
Withdrawn NCT00623909 - Laser Therapy in the Treatment of Post Thoracotomy Pain; A Pilot Study N/A
Recruiting NCT05270187 - Multiwave Locked System Laser for Patients With Bell's Palsy. N/A
Active, not recruiting NCT06185426 - Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury Early Phase 1
Completed NCT04070170 - Laser Therapy on Orthodontic Tooth Movement N/A
Completed NCT04811144 - Clinical Application of Er:YAG Dental Laser System N/A
Recruiting NCT05723094 - Effect of Low-Level Laser Therapy on Stability During Retention Phase. N/A
Recruiting NCT04292704 - A Protocol for the Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis N/A