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Completed

NCT Number: NCT01813786

Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars

Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser & Skin Surgery Center of New York

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is a healthy male or female between 18 and 85 years old
  • Has unwanted scars not including atrophic scars 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 biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
  • Has Fitzpatrick skin types I 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 a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
  • 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 subject has a history of keloids.
  • 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.
  • The subjects has an allergy to lidocaine and epinephrine.

Treatment and study plan

755nm Alexandrite Laser with handpiece 2

Device

Focusing energy on skin

755nm Alexandrite Laser with handpiece 1

Device

focusing energy at skin surface

755nm Alexandrite Laser with handpiece 3

Device

Focusing energy on skin

Primary outcomes

  1. Subject Biopsy Sampling

    Time frame: 3 months post last treatment

    Histological examination of tissue samples will be compared between baseline and 3 months post treatment.

Secondary outcomes

  1. Photographic evaluation as a measure of improvement.

    Time frame: up to 3 months post last treatment

    2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement.

  2. Subject Biopsy Sampling

    Time frame: 2 weeks post treatment

    Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment.

  3. Subject Biopsy Sampling

    Time frame: 1 month post treatment

    Histological examination of tissue samples will be compared between baseline and 1 month post treatment.

Other outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: up to 3 months post last treatment

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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