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OpenTrials
Completed

NCT Number: NCT02091102

Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles

The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles using a 755nm Alexandrite Laser.

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Key information

Conditions

Wrinkles

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McDaniel Institute of Anti Aging Research

Virginia Beach, Virginia, 23462, 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 non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old.
  • 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.

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 Retin A or 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 or has an autoimmune disorder.
  • The subject has an allergy to lidocaine and epinephrine.

Treatment and study plan

755nm Alexandrite Laser

Device

755nm Alexandrite Laser for the treatment of Wrinkles

Primary outcomes

  1. Photographic Evaluation of Wrinkle Severity at Baseline

    Time frame: Baseline

    Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.

  2. Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment

    Time frame: 1 Month Follow Up Post Last Treatment

    Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.

  3. Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment

    Time frame: 3 Month Follow Up Post Last Treatment

    Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.

  4. Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment

    Time frame: 4 Month Follow Up Post Last Treatment

    Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.

  5. Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment

    Time frame: 6 Month Follow Up Post Last Treatment

    Blinded evaluators grade photographs using the Fitzpatrick wrinkle severity scale and provide an overall score for each timepoint. The Fitzpatrick wrinkle scale classifies wrinkles on a scale from 1 (mild) to 9 (severe). Scores of 1-3 are for mild wrinkles, meaning that there are fine texture changes with subtly accentuated skin lines. Scores of 4-6 are for fine to moderate depth wrinkles or moderate amount of lines with distinct popular elastosis and dyschromia. Scores of 7-9 are for fine to deep wrinkles, with numerous lines with or without redundant skin folds. It is characterized by multiple papules and confluent elastosis.

Other outcomes

  1. Satisfaction Questionnaire

    Time frame: up to 6 months post last treatment

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Official study title

Evaluation of the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2014
Registry last updated
Nov 25, 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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