Recruiting

Picosecond Laser

Sponsor:

Syneron Medical

Code:

NCT02891239

Conditions

Benign Pigmented Lesions

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

PicoWay

Study Details

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

Study ID

NCT02891239

Start date

Sep, 2016

Status verified date

Sep, 2016

Completion date

Sep, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Healthy female and male subjects between 18 to 70 years of age
2. Fitzpatrick skin type I-VI
3. 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.
4. Willing to receive the proposed PicoWay treatments and comply with all study (protocol) requirements to remove unwanted benign pigmented lesions.
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. Taking medication(s) for which sunlight is a contraindication
4. Active sun tan
5. 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
6. History of squamous cell carcinoma or melanoma
7. History of keloid scarring, abnormal wound healing and / or prone to bruising
8. 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
9. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
10. Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
11. Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months
12. 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
13. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PicoWay laser treatment

3 wavelength tattoo treatment with picosecond laser (PicoWay)

Interventions

PicoWay

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

Primary outcome measure

  • Blinded evaluation of pigmentation clearance [ Time Frame: 8 weeks post final treatment ]

Central Contacts and Locations

Central contacts

Locations

Syneron Candela Institute for Education Clinic

Recruiting

Wayland, Massachusetts, United States, 01778

Contacts

Meghan Murphy, BSN

508-358-0359

Principal Investigator:

Konika Schallen, MD

More Information

Sponsor

Syneron Medical

Last update posted

Sep 14, 2016

Last verified

Sep, 2016

Keywords

  • laser treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Syneron Medical on 2016-09-14.