785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

NCT ID: NCT02891239

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-09-30

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.

Detailed Description

This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment.

Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or proceed to the 8-weeks follow-up (FU) visit with no more treatments.

Conditions

Benign Pigmented Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PicoWay laser treatment

3 wavelength tattoo treatment with picosecond laser (PicoWay)

Group Type: EXPERIMENTAL

PicoWay

Intervention Type: 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

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

Intervention Type: DEVICE

Other Intervention Names

PicoWay device

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneron Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Konika Schallen, MD

Role: PRINCIPAL_INVESTIGATOR

Syneron Candela Institute for Education Clinic

Locations

Syneron Candela Institute for Education Clinic

Wayland, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Konika Schallen, MD

Role: CONTACT

konikap@syneron.com

508-358-7400

Facility Contacts

Meghan Murphy, BSN

Role: primary

508-358-0359

References

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.

Reference Type: BACKGROUND

PMID: 26175187 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26922302 (View on PubMed)

Other Identifiers

DHF21261

Identifier Type: -

Identifier Source: org_study_id