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

NCT01403597 | Completed

• 1 other identifier: SCP-1
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Laser Therapy; Rejuvenation

Keywords

Skin wrinkling; Skin aging; Skin pigmentation

Outcome Measures

Primary Outcomes (2)

• Safety of treatment

  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.

  11 months

• Efficacy of Treatment

  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

  11 months

Secondary Outcomes (2)

• Patient Satisfaction

  11 months

• Patient Comfort

  11 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Refirme ST Applicator and Matrix RF Applicator DEVICE

5 treatments with combination of devices every 4 weeks to the facial (or sub facial regions).

Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have skin condition that requires ablation and resurfacing such as visible lines, pores, pigmentation, and elastosis that correlate to a score of 2 6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis
• Age: At least 21 years of age and not older than 65 years of age
• Sex male or female
• For female candidates - post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).
• Agrees to sign the Informed Consent
• Desire to improve their facial skin appearance
• Willingness to have photographs of the treated area taken that may be used for marketing and educational presentation and/or publications
• Willingness to follow the treatment and follow-up schedule and the post-treatment care
• Not planning to improve their skin appearance in a different procedure during the complete experimental period.

You may not qualify if:

• History of keloid scarring or of abnormal wound healing
• Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions, including, but not limited to: excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), indurate acne, varicella scars, open lacerations or abrasions and active cold sores or herpes sores prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course.
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation
• Vascular lesion, tattoo or permanent make-up in the treated area
• Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breastfeeding.
• Suffering from hormonal imbalance, as per the Investigator's discretion.
• Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
• Having a permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
• Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
• Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), or pertinent neurological disorders.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Sponsors & Collaborators

• Syneron Medical: lead

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 27, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-11