Impact of Synergistic Sequential Treatment (SST)

Completed · Not applicable

Conditions studied: Improvement of Wrinkles/Elastosis as Well as General Skin Tone

In brief

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type II-V will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects. Subjects should present visible wrinkles and/or elastosis requiring treatment. Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75% of the subjects.

Key facts

Study ID

NCT01940445

Run by

Lumenis Be Ltd.

People needed

17

Starts

2013-09-01

Expected to finish

2015-06-01

Last updated by the study team

2017-01-26

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to read, understand and provide written Informed Consent;
• Healthy adult, male or female, 30-65 years of age with Fitzpatrick-Goldman skin type II-V;
• Having suitable facial areas with wrinkles Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6 to be treated;
• 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.

You may not qualify if…

• Skin type I, 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 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, varicella scars, or severe open wound stages of rosacea.
• 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, including, but not limited to, severe rosacea
• 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, pre-cancerous or is not deemed suitable for photo therapy, as determined by a dermatologist.

Where it is running

• Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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