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OpenTrials
Completed

NCT Number: NCT01754233

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

The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, 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 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.

Treatment and study plan

755nm Alexandrite Laser

Device

755nm Alexandrite Laser for epidermal and dermal pigmented lesions

Primary outcomes

  1. Photographic Evaluation

    Time frame: up to 4 months post last treatment

Secondary outcomes

  1. Reporting of Adverse Events

    Time frame: up to 4 months post last treatment

  2. Satisfaction Questionnaire

    Time frame: up to 4 months post treatment

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2012
Registry last updated
Oct 26, 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.