Evaluation of the 755nm Alexandrite for the Treatment of... | NCT01754233

Studies
Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions

NCT01754233

Sponsor

Cynosure, Inc.

Status

Completed

Last Update Posted

Oct 26, 2020Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Dermal and Epidermal Pigmented Lesions

Interventions

755nm Alexandrite Laser

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

Dec 18, 2012

First Posted Date

Dec 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2020

Last Update Posted Date

Oct 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Label	Type	Description	Intervention Names
755nm Alexandrite Laser	Experimental	755nm Alexandrite Laser	Device: 755nm Alexandrite Laser

Name	Type	Description	Arm Group Labels	Other Names
755nm Alexandrite Laser	Device	755nm Alexandrite Laser for epidermal and dermal pigmented lesions	755nm Alexandrite Laser

Measure	Description	Time Frame
Photographic Evaluation		up to 4 months post last treatment

Measure	Description	Time Frame
Reporting of Adverse Events		up to 4 months post last treatment
Satisfaction Questionnaire		up to 4 months post treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is a healthy male or female between 18 and 85 years old
Has unwanted dermal and/or epidermal pigmented lesions or desires skin toning and wishes to undergo laser treatments.
Is willing to consent to participate in the study.
Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
Has Fitzpatrick skin types III to IV.

Exclusion Criteria:

The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
The subject is hypersensitive to light exposure OR takes photo sensitized medication.
The subject has active or localized systemic infections
The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
The subject has used Accutane within 6 months prior to enrollment.
The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
The subjects had prior treatment with laser or other devices in the treatment area within 3 months.
The subject has a history of keloids or hypertrophic scarring.
The subject has evidence of compromised wound healing.
The subject has a history of squamous cell carcinoma or melanoma
The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
Is allergic to topical lidocaine or topical steroids.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007834	Lasers
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies