NCT02635880

Completed

A Clinical Evaluation of a Novel Multi-Wavelength Laser for ...

Cutera Inc.Source

Cutera Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

C-15-EN08

Study Type

interventional

Actual enrollment (reported)

32

Locations

1 country

Sites

1

Timeline

Study Start

September 2015

Actual (reported)

Primary Completion

February 2016

Actual (reported)

Study Completion

March 23, 2016

Actual (reported)

Brief Summary

To evaluate the safety and efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple wavelengths for removal of benign pigmented lesions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 32 participants
Study completion date: March 23, 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2015
Actual (reported)
First Submitted
December 17, 2015
Actual (reported)
First Posted
December 21, 2015
Actual (reported)
Primary Completion
February 2016
Actual (reported)
Study Completion
March 23, 2016
Actual (reported)
Results Posted
July 6, 2018
Actual (reported)

Last Updated: July 6, 2018
Status Verified: January 2016
Results QC Date: July 2, 2018
Last Update Submitted: July 2, 2018

Conditions

Pigmented Skin Lesion of Suspected Benign Nature

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Change of Treated Lesions
Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement.
Baseline and 6 weeks post-final treatment

Secondary Outcomes (1)

Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject
6 weeks post-final treatment

Study Arms (1)

Investigational Enlighten Device

EXPERIMENTAL

Laser treatment for removal of benign pigmented lesions (BPLs) with Nd:YAG dual-wavelength, dual-pulse duration laser.

Device: Investigational Enlighten Device

Interventions

Investigational Enlighten DeviceDevice

Up to 3 laser treatments, spaced 4 to 6 weeks apart

Investigational Enlighten Device

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female or Male, 18 to 65 years of age (inclusive).
Fitzpatrick Skin Type I - III (Appendix 3).

Sponsors & Collaborators

Cutera Inc.
Industrylead

Study Sites (1)

Cutera Research Center

Brisbane, California, 94005, United States

Results Point of Contact

Title: Ginger Pocock
Organization: Cutera

Study Officials

Lourdes Moldre, NP
Cutera Inc.
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

32 participants (actual enrollment reported by the registry).

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

December 17, 2015

First Posted

December 21, 2015

Study Start

September 2015

Actual (reported)

Clinical diagnosis of benign pigmented lesions located on the hand, body or face.

Presence of 5 or more benign pigmented lesions in the treatment area, ranging in diameter from 2 to 8 mm.

Has not used any prescription or over-the-counter topical creams (such as hydroquinone, retinoids or corticosteroids) in the designated treatment area within 4 weeks of enrollment in the study and is willing to refrain from use for the duration of the study.

Subject must be able to read, understand and sign the Informed Consent Form.

Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.

Wiling to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment and every day for the duration of the study, including the follow-up period.

Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.

Agree to not undergo any other procedure(s) for the treatment of BPL during the study.

Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study, and no plans to become pregnant for the duration of the study.

You may not qualify if:

Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as chemical peel, laser or light-based procedure, or surgery.
Presence of pre-malignant or malignant lesion in the treatment area (such as, but not limited to pigmented actinic keratosis, lentigo maligna or lentigo maligna melanoma) or history of a pre-malignant or malignant lesion in the treatment area.
Shows signs of actinic bronzing and/or excessively tanned in areas to be treated, and unable or unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
Pregnant and/or breastfeeding.
Having an infection, dermatitis or a rash in the treatment area.
Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
Suffering from coagulation disorders or taking prescription anticoagulation medications.
History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
History of vitiligo, eczema, or psoriasis.
History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
History of seizure disorders due to light.
Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
+7 more criteria

Contact the study team to confirm eligibility.

Primary Completion

February 2016

Actual (reported)

Study Completion

March 23, 2016

Actual (reported)

Last Updated

July 6, 2018

Results First Posted

July 6, 2018

Record last verified: 2016-01

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02635880
Data provider: ClinicalTrials.gov
Source updated: 2018-07-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:30 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Investigational Enlighten Device

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations