In-vivo Analysis of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue

NCT01026662 | Unknown

• 1 other identifier: eMatrixCO2 Preab
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will: Evaluate the in vivo effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment.

Conditions

Abdominoplasty

Keywords

Aesthetic dermatology

Outcome Measures

Primary Outcomes (2)

• Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points

  Immediate, 1, 3, 10, 30 days

• Record number and type of any AE during the study

  Throughout study

Study Arms (1)

Abdominoplasty

Subjects scheduled for abdominoplasty surgery

Procedure: Ablation and skin resurfacing; Device: eMatrixCO2

Interventions

Ablation and skin resurfacing PROCEDURE

Subjects will receive treatment on the abdomen at different timepoints prior to a scheduled abdominoplasty. Following tissues excision samples of the treated tissue will be taken for analysis.

Abdominoplasty

eMatrixCO2 DEVICE

Abdominoplasty

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Subjects scheduled for an abdominoplasty surgery

You may qualify if:

• Informed consent agreement signed by the subject.
• Healthy males or females older than 21 to 60 years of age.
• Fitzpatrick skin type I-V (Although the systems are cleared for all skin types I-VI, it is recommended to use the Matrix applicators on skin types I - V).
• Willingness to follow the treatment and follow-up schedule and the post-treatment care.
• 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).

You may not qualify if:

• Pregnant and/or breastfeeding.
• 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.
• Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session.
• Use of retinoids, antioxidants or therapeutic skin nourishing supplements at medicinal concentration within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
• Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
• Having received collagen/fat injections or other methods of augmentation with injected or implanted material in the treated area within 9 months of treatment or during the study.
• Having received Botox in the treated area within 6 months of treatment or during the study.
• Having undergone any other surgery in the treated area within 6 months of treatment (or more if skin has not healed completely) or during the study.
• 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: active acne, excessive skin dryness, psoriasis, eczema, rash, rosacea (particularly severe open wound stage), 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 immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
• History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• Suffering from hormonal imbalance, as per the Investigator's discretion.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

SouthWestern Medical Center

Dallas, Texas, 75390-8843, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Abdominal Skin tissue

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2010
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

US (1)