UnknownNot Applicable

785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

United States60 participantsStarted 2016-09

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blinded evaluation of pigmentation clearance

Timeframe: 8 weeks post final treatment

Trial details

NCT IDNCT02891239

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-09

Contact for this trial

Konika Schallen, MD

508-358-7400 konikap@syneron.com

View on ClinicalTrials.gov More Benign Pigmented Lesions trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria