NCT01811030

Brief Summary

Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

December 19, 2020

Completed
Last Updated

January 14, 2021

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

December 6, 2012

Results QC Date

October 19, 2020

Last Update Submit

December 22, 2020

Conditions

Scars

Outcome Measures

Primary Outcomes (2)

  • Photographic Evaluation of Scar Clearance

    The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.

    1 Month Post Last Treatment

  • Photographic Evaluation of Scar Clearance

    The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.

    3 Months Post Last Treatment

Study Arms (1)

755nm Alexandrite Laser

EXPERIMENTAL

755nm Alexandrite Laser

Device: 755nm Alexandrite Laser

Interventions

755nm Alexandrite LaserDEVICE

755nm Alexandrite Laser

755nm Alexandrite Laser

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is a healthy male or female between 18 and 85 years old.
  • Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.
  • 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

You may not qualify if:

  • Is hypersensitive to light exposure.
  • Has active localized or systemic infection.
  • Is taking medication(s) for which sunlight is a contraindication.
  • Has a history of squamous cell carcinoma or melanoma.
  • Has a history of keloid scarring.
  • Has used 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.
  • Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  • Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
  • Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
  • Has any other reason determined by the physician to be ineligible to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Results Point of Contact

Title
Jamie Trimper
Organization
Cynosure
jamie.trimper@cynosure.com
800-886-2966

Study Officials

  • Patricia Krantz

    Cynosure, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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 6, 2012

First Posted

March 14, 2013

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 14, 2021

Results First Posted

December 19, 2020

Record last verified: 2020-12

Locations

US(1)