785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

NCT02891239 | Unknown

• 1 other identifier: DHF21261
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.

Conditions

Benign Pigmented Lesions

Keywords

laser treatment

Outcome Measures

Primary Outcomes (1)

• Blinded evaluation of pigmentation clearance

  Global percentage of pigmentation clearance, as assessed by blinded evaluators based on comparing pre and post treatment photos.

  8 weeks post final treatment

Secondary Outcomes (4)

• Global percentage of pigmentation clearance

  8 weeks post final treatment

• Number of patients with adverse events

  Through study completion, average of 1 year

• Investigator satisfaction with treatment

  8 weeks post final treatment

• Subject satisfaction with treatment

  8 weeks post final treatment

Study Arms (1)

PicoWay laser treatment

EXPERIMENTAL

3 wavelength tattoo treatment with picosecond laser (PicoWay)

Device: PicoWay

Interventions

PicoWay DEVICE

solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wavelength of 785 nm that was added to the system

Also known as: PicoWay device

PicoWay laser treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male subjects between 18 to 70 years of age
• Fitzpatrick skin type I-VI
• Presence of unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, Nevis of Ota, Nevus of Ito and hyperpigmentation. Multiple lesions can be treated.
• Willing to receive the proposed PicoWay treatments and comply with all study (protocol) requirements to remove unwanted benign pigmented lesions.
• Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked).
• 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)
• Informed consent process is completed and subject consent is signed.

You may not qualify if:

• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
• Hypersensitivity to light exposure
• Taking medication(s) for which sunlight is a contraindication
• Active sun tan
• 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
• History of squamous cell carcinoma or melanoma
• History of keloid scarring, abnormal wound healing and / or prone to bruising
• Use of 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
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
• Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
• Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
• Subjects with pigmented lesions that are considered not acceptable by the study doctor or any condition that, in the study doctor's opinion, would make it unsafe to treat
• As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Syneron Candela Institute for Education Clinic

Wayland, Massachusetts, 01778, United States

RECRUITING

Related Publications (2)

• Bernstein EF, Schomacker KT, Basilavecchio LD, Plugis JM, Bhawalkar JD. A novel dual-wavelength, Nd:YAG, picosecond-domain laser safely and effectively removes multicolor tattoos. Lasers Surg Med. 2015 Sep;47(7):542-548. doi: 10.1002/lsm.22391. Epub 2015 Jul 14.

  PMID: 26175187 BACKGROUND

• Levin MK, Ng E, Bae YS, Brauer JA, Geronemus RG. Treatment of pigmentary disorders in patients with skin of color with a novel 755 nm picosecond, Q-switched ruby, and Q-switched Nd:YAG nanosecond lasers: A retrospective photographic review. Lasers Surg Med. 2016 Feb;48(2):181-7. doi: 10.1002/lsm.22454.

  PMID: 26922302 BACKGROUND

Study Officials

• Konika Schallen, MD

  Syneron Candela Institute for Education Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konika Schallen, MD

CONTACT

508-358-7400; konikap@syneron.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

US (1)