Clinical Evaluation of M22 ResurFX 1565nm Module

NCT01796626 | Completed

• 1 other identifier: LUM-ABU-M22-ResurFX-12-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects. Subjects should present visible wrinkles and/or striae requiring treatment. Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least 50% using VAS as compared to baseline, for at least 75% of the subjects.

Conditions

Wrinkles; Striae

Outcome Measures

Primary Outcomes (1)

• Improvement

  Investigator subjective evaluation of the extent of wrinkles improvement at the 3 month follow-up visit as assessed by Fitzpatrick-Goldman Wrinkle Class / Elastosis Score classification, striae improvement will be assessed using VAS.

  3 months following 3rd treatment

Secondary Outcomes (8)

• Improvement

  1 and 6 months following 3rd treatment

• Blinded improvement

  1 year following study initiation

• Skin response

  Following treatment #1, 2 and 3

• Downtime

  Following treatment #1, 2 and 3

• Improvement by subject

  1, 3 and 6 months follow up

Study Arms (2)

Wrinkle treatment

EXPERIMENTAL

Wrinkle treatment with ResurFX 1565nm module

Device: M22 ResurFX module

Striae treatment

EXPERIMENTAL

Striae treatment with the REsurFX 1565nm module

Device: M22 ResurFX module

Interventions

M22 ResurFX module DEVICE

The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.

Striae treatment; Wrinkle treatment

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to read, understand and provide written Informed Consent;
• Healthy adult, male or female, 25-55 years of age with Fitzpatrick-Goldman skin type I-IV;
• Having suitable areas of treatment of facial areas to be treated with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 or striae alba present for more than 1 year;
• Able and willing to comply with the treatment/follow-up schedule and requirements;
• Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to enrollment and throughout the course of the study.

You may not qualify if:

• Any of the following will exclude the subject from the study: skin type V-VI
• Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding;
• History of post inflammatory hyperpigmentation
• Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study;
• Use of photosensitive medication for which light exposure is contraindicated.
• Use of oral isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study. Note: skin must regain its normal degree of moisture prior to treatment;
• Prior treatment, such as chemical peel (especially phenol based) or dermabrasion, in treated area within 3 months of initial treatment or during the course of the study;
• Prior skin treatment with non-ablative laser or other devices in treated area within 6 months of initial treatment or during the course of the study;
• Prior use of collagen, fat injections or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 12 months of initial treatment or during the course of the study. Treatment may not be performed at all over permanent dermal implants;
• Prior use of Botox in treatment area within 6 months;
• Prior ablative resurfacing procedure or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study;
• Any other surgery in treated area within 9 months of initial treatment or during the course of the study;
• History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area;
• Showing symptoms of hormonal disorders, as per the Investigator's discretion (such as Melasma, Chloasma);
• Concurrent inflammatory skin conditions, including, but not limited to, rosacea of any severity;

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (2)

DCLA

San Diego, California, United States

Location

New York Laser & Skin Care

New York, New York, 10028, United States

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchel P Goldman, MD

  DCLA

  PRINCIPAL INVESTIGATOR

• Arielle NB Kauvar, MD

  New York Laser & Skin Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2013
• First Posted: February 22, 2013
• Study Start: December 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

US (2)