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OpenTrials
Completed

NCT Number: NCT01745627

755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars

Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and 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: Yes

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

Inclusion criteria

  • Healthy male or female subjects between 18 and 85 years of age.
  • Subjects with Fitzpatrick skin types I to VI.
  • Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
  • Subject who are willing to consent to participate in the study.

4.2 Exclusion Criteria

  • Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
  • Hypersensitive to light exposure.
  • Active localized or systemic infections.
  • Taking medication for which sunlight is a contraindication.
  • History of squamous cell carcinoma or melanoma.
  • History of keloid scarring.
  • Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
  • Prior treatment with laser or other devices in treatment area within 3 months
  • History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
  • Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
  • Subjects that the physician determines ineligible based on standard of care treatment.

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Treatment and study plan

755nm Alex laser

Device

Primary outcomes

  1. Clearance Based on Photographic Scale

    Time frame: 1 months post last treatment

    This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.

  2. Clearance Based on Photographic Scale

    Time frame: 3 months post last treatment

    This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2012
Registry last updated
Dec 23, 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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