Clinical trial NCT02700204: Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
Official title: Histological Study to Evaluate Skin Changes After PicoWay® 1064 nm and 532nm Picosecond Fractional Laser Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyschromia
Lead sponsor: Syneron Medical
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, two-arm, histological evaluation study.

Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive PicoWay fractional treatment:

Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece Subjects will receive one treatment for peri auricular and/or Buttocks according the Investigator decision, with the fractional hand-piece

All subjects will have biopsies from the treated area:

* at baseline prior to treatment;
* immediately after treatment (within 30 minutes) or 48 hours after treatment;
* 2 months after treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Detailed description: This histological study is a prospective clinical study to evaluate skin biopsies after a single PicoWay treatment with the 532nm or 1064nm fractional hand-piece.

Up to 30 healthy candidates, will be enrolled at up to 2 participating study sites. Subjects in this study will be assigned to Arm 1 or Arm 2, taking into account skin type, to receive fractional treatment for peri auricular and/or Buttocks according to investigator decision:

Arm 1: 532nm hand-piece Arm 2: 1064nm hand-piece

Subjects will receive one treatment for peri auricular and/or Buttocks, with the fractional hand-piece. The investigator may use a multiplicity of energy levels in area or subarea in a single treatment, in order to titrate the optimum energy level. Further, if the investigator elects to, the Picoway handpiece can have at its distal end (at the distance gauge ending) a flat piece of a transparent plastic/glass (with appropriate anti reflective coating if desired), which will be in contact with the skin. In this case, the investigator may also elect to use a coupling gel as a matching medium between the skin and the glass.

All subjects will have biopsies of the treated area (a single or two peri or post-auricular, buttocks) at baseline prior to treatment. Biopsies from each area will also be performed immediately after treatment (within 30 minutes) and/or at \~48 hours after treatment, according to physician discretion, and at the 2-month follow-up.

Topical anesthetic (ointment) or intradermal injected solution may be used prior to treatment

Eligibility criteria: Inclusion Criteria:

1. Healthy female and male subjects between 18 to 75 years of age
2. Has Fitzpatrick skin type I-VI
3. Subjects seeking treatment for having blemished skin, where the blemishes are of the type that photo rejuvenation would be a potential treatment option, including dyschromia, acne scars, wrinkles, etc., and willing to undergo laser treatment and skin biopsies pre-treatment, immediately after treatment, and at the 2-month follow-up
4. Willing to receive the proposed PicoWay fractional treatments and comply with all study (protocol) requirements including consenting to a minimum of 5 biopsies: at least 1 biopsy pretreatment, at least 2 biopsies immediately after treatment (at least 1 from each side), or at least 2 biopsies at 48 hours after treatment (at least 1 from each side) and at least 2 biopsies at 2 months after treatment (at least 1 from each side)
5. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
6. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
7. Informed consent process is completed and subject consent is signed

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
2. Hypersensitivity to light exposure
3. Active sun tan in facial area for patient who will treat peri-auricular area.
4. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
5. Is taking medication(s) for which sunlight is a contraindication
6. Has a history of squamous cell carcinoma or melanoma
7. History of keloid scarring, abnormal wound healing and / or prone to bruising
8. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
9. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness.
10. A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months
11. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
12. Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
13. Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
14. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study

Primary outcomes:
measure: To collect skin biopsies after fractional PicoWay treatments
timeFrame: day 0 up to 2 months
Secondary outcomes:
measure: Histological evidence of LIOBs and location of LIOBs
timeFrame: day 0 and at 48 hours
measure: Observation of erythema/edema after treatment
timeFrame: day 0 up to 2 months
measure: Histological evidence of an inflammatory response
timeFrame: at 48 hours
measure: Histological evidence of new collagen growth
timeFrame: at 2 months
measure: Number of subjects with adverse events
timeFrame: day 0, up to 7 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Arielle N. Kauvar,
state: New York
Study officials:
affiliation: NY Laser Skin Care
name: Arielle Kauvar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brightman L, Goldman MP, Taub AF. Sublative rejuvenation: experience with a new fractional radiofrequency system for skin rejuvenation and repair. J Drugs Dermatol. 2009 Nov;8(11 Suppl):s9-13.