In-vivo Analysis and Clinical Evaluation of the Performance of a Fractional CO2 Laser System (eMatrixCO2)

NCT00992277 | Completed Phase 2

• 1 other identifier: DC75061
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

This study will: Evaluate the in vivo histological and molecular effects of treatment with eMatrixCO2 and to determine the dynamics of their development over time following treatment. Determine the safety and efficacy of treatment with eMatrixCO2 for use in Aesthetic dermatological procedures requiring the ablation, vaporization, excision, incision, or coagulation of soft tissue.

Conditions

Aesthetic Dermatology

Outcome Measures

Primary Outcomes (2)

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

  over time following treatment.

• Record number and type of any AE during the study

  study duration

Study Arms (1)

Facial

EXPERIMENTAL

Skin rejuvenation treatments

Procedure: Ablation and skin resurfacing

Interventions

Ablation and skin resurfacing PROCEDURE

Facial

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent agreement signed by the subject.
• Healthy males or females older than 21 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 permanent implant in the facial skin area, such as an injected chemical substance - Not relevant for the abdominoplasty group.
• 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 within 2 months of treatment or during the study and oral retinoids within 6 months of the study.
• Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study- Not relevant for the abdominoplasty group.
• Having received treatment with light, RF or other devices in the treated area within 6 months of treatment or during the study.
• Having received Botox/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 undergone a resurfacing procedure, face lift or eyelid surgery within a year of treatment or during the study- Not relevant for the abdominoplasty group.
• 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.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (3)

Scripps Health

San Diego, California, 92130, United States

Location

South Dermatology Institute

Tustin, California, 92780, United States

Location

Zel Skin & Laser Specialists

Saint Edina, Minnesota, 55424, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

US (3)