Evaluation of Non-ablative and Fractional Combination Treatment for Improvement in Skin's Appearance
This study has been completed.
Information provided by (Responsible Party):
First received: July 20, 2011
Last updated: November 28, 2014
Last verified: November 2014
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.
|Laser Therapy Rejuvenation||Device: Refirme ST Applicator and Matrix RF Applicator|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
Further study details as provided by Syneron Medical:
Primary Outcome Measures:
- Safety of treatment [ Time Frame: 11 months ]The treatment will be considered safe if no cutaneous reactions (including excessive erythema and edema, blister formation, erosion, ulcer, scarring, infection, pruritis or allergic reactions) except of mild pigment can be detected at the site of treatment at the final follow up.
- Efficacy of Treatment [ Time Frame: 11 months ]The treatment will be considered efficacious if a result greater than ≥3 moderate to significant on GAI scale) of overall skin improvement will be marked at the final follow up
Secondary Outcome Measures:
- Patient Satisfaction [ Time Frame: 11 months ]The treatment will be considered satisfactory by the patient if a result ≥ 3 in the patient satisfaction scale will marked at the final follow up.
- Patient Comfort [ Time Frame: 11 months ]The treatment will be considered comfortable if a result ≥ 2 in the patient comfort assessment scale will marked at the end of at least 3/5 or 2/4 treatments.
|Study Start Date:||January 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
The defined areas for treatment are the entire face or at least two facial sub areas (e.g., peri-orbital and peri oral) with the combination of two devices where a total of 5 treatments every 4 weeks will be administered
Device: Refirme ST Applicator and Matrix RF Applicator
5 treatments with combination of devices every 4 weeks to the facial (or sub facial regions).
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.
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