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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Syneron Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Syneron Medical
ClinicalTrials.gov Identifier:
NCT01026662
First received: December 3, 2009
Last updated: April 7, 2010
Last verified: April 2010
  Purpose

This study will:

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


Condition Intervention Phase
Abdominoplasty
Procedure: Ablation and skin resurfacing
Device: eMatrixCO2
Phase 2
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: In-vivo Analysis of a Fractional CO2 Laser System (eMatrixCO2) Intended for Treatment of Soft Tissue

Further study details as provided by Syneron Medical:

Primary Outcome Measures:
  • Histological and molecular assessment of tissue taken following treatment with different parameters and at various time points [ Time Frame: Immediate, 1, 3, 10, 30 days ] [ Designated as safety issue: No ]
  • Record number and type of any AE during the study [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Abdominal Skin tissue


Estimated Enrollment: 5
Study Start Date: November 2009
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Abdominoplasty
Subjects scheduled for abdominoplasty surgery
Procedure: Ablation and skin resurfacing
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.
Device: eMatrixCO2

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Subjects scheduled for an abdominoplasty surgery

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
  • 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 actinic keratosis, 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.

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.
  • Participation in a study of another device or drug within three month prior to enrollment or during the study.
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01026662

Locations
United States, Texas
SouthWestern Medical Center
Dallas, Texas, United States, 75390-8843
Sponsors and Collaborators
Syneron Medical
  More Information

No publications provided

Responsible Party: VP Research and Development, Syneron
ClinicalTrials.gov Identifier: NCT01026662     History of Changes
Other Study ID Numbers: eMatrixCO2 Preab
Study First Received: December 3, 2009
Last Updated: April 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Syneron Medical:
Aesthetic dermatology

ClinicalTrials.gov processed this record on July 29, 2014