Impact of M22 Synergistic Sequential Treatment (SST)

Lumenis

Status

Completed

Conditions

Improvement of Wrinkles/Elastosis and/or Pigmentation

Treatments

Device: M22 IPL and ResurFX

Study type

Interventional

Funder types

Industry

Identifiers

NCT02032771

LUM-ABU-M22-IPL&ResurFX-13-02

Details and patient eligibility

About

Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of 3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their facial skin appearance.

Hypothesis: The SST will improve the appearance of the wrinkles/elastosis and/or pigmentation by at least 1 on the FES scale or ≥50% in category scale at 3 months follow-ups in at least 50% of the study population.

Enrollment

33 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Able to read, understand and provide written Informed Consent;
Healthy adult, male or female, 30-65 years of age with Fitzpatrick-Goldman skin type I-V;
Having suitable facial areas with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 to be treated;
Having suitable facial areas with mild to moderate age/sun-related facial pigmentation
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 (such as an intrauterine device, birth control pills, condom with spermicidal, Nova ring, partner with vasectomy or abstinence) at least 3 months prior to enrollment and throughout the course of the study.

Exclusion criteria

Skin type 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
Heavy smoker (>1 pack of cigarettes a day)
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 3 months of initial treatment or during the course of the study. Note: skin must regain its normal degree of moisture prior to treatment.
Having indurate acne in treated area.
Any dermal/epidermal damage or disorder, mainly vascular or textural lesions, in treated area
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 laser/light or another device treatment 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.
Participation in a study of another investigational device or drug involving the same anatomical site within 3 months prior to enrollment or during this evaluation, or if not involving the same anatomical site, as per the Investigator's discretion
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, Open laceration or abrasion of any sort on area to be treated during the course of treatment
Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment;
Multiple dysplastic nevi in area to be treated
Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to treatment (as per the subject's physician discretion)
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications
Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer on the face.
Pigmented lesion in the treated area that appears cancerous or is not deemed suitable for photo therapy, as determined by a dermatologist.
Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process;
Mentally incompetent, prisoner or evidence of active substance or alcohol abuse
Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study.
For subjects undergoing test spots: considerable undesired response consisting of skin hypopigmentation (long term whitening), a scar or pre scar formation, or any response deemed by the Investigator as grounds for exclusion.
Allergies to anesthetics.