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CompletedNCT02091102Updated Nov 25, 2020Results posted

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

An interventional study of 755nm Alexandrite Laser in Wrinkles, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Wrinkles
03

In context

Lead sponsor

Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Is a healthy non-smoking (must have quit 6 months prior) male or female between 18 and 65 years old.
  2. Is willing to consent to participate in the study.
  3. 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

Exclusion Criteria:

  1. 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.
  2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
  3. The subject has active or localized systemic infections.
  4. 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}).
  5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
  6. 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.
  7. The subject has used Retin A or Accutane within 6 months prior to enrollment.
  8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
  9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
  10. The subject has a history of keloids.
  11. The subject has evidence of compromised wound healing.
  12. The subject has a history of squamous cell carcinoma or melanoma.
  13. 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.
  14. The subject has an allergy to lidocaine and epinephrine.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    755nm Alexandrite Laser

    755nm Alexandrite Laser

    Device: 755nm Alexandrite Laser

Interventions

  • Device755nm Alexandrite Laser

    755nm Alexandrite Laser for the treatment of Wrinkles

06

What researchers measure

Primary outcomes

  1. Photographic Evaluation of Wrinkle Severity at 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.

    Time frame: Baseline

  2. Photographic Evaluation of Wrinkle Severity at 1 Month 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.

    Time frame: 1 Month Follow Up Post Last Treatment

  3. Photographic Evaluation of Wrinkle Severity at 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.

    Time frame: 3 Month Follow Up Post Last Treatment

  4. Photographic Evaluation of Wrinkle Severity at 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.

    Time frame: 4 Month Follow Up Post Last Treatment

  5. Photographic Evaluation of Wrinkle Severity at 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.

    Time frame: 6 Month Follow Up Post Last Treatment

Other outcomes

  1. Satisfaction Questionnaire

    Time frame: up to 6 months post last treatment

07

Results

Posted Nov 25, 2020

Participant flow

Participant flow — Overall Study
Milestone755nm Alexandrite Laser
Started20
Completed20
Not completed0

Outcome measures

PrimaryPhotographic Evaluation of Wrinkle Severity at 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.

Time frame:
Baseline
Reported as:
Mean · score on a scale
Photographic Evaluation of Wrinkle Severity at Baseline
score on a scale755nm Alexandrite Laser
Photographic Evaluation of Wrinkle Severity at Baseline5.25 ± .851
PrimaryPhotographic Evaluation of Wrinkle Severity at 1 Month 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.

Time frame:
1 Month Follow Up Post Last Treatment
Reported as:
Mean · score on a scale
Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment
score on a scale755nm Alexandrite Laser
Photographic Evaluation of Wrinkle Severity at 1 Month Post Last Treatment4.74 ± .991
PrimaryPhotographic Evaluation of Wrinkle Severity at 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.

Time frame:
3 Month Follow Up Post Last Treatment
Reported as:
Mean · score on a scale
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment
score on a scale755nm Alexandrite Laser
Photographic Evaluation of Wrinkle Severity at 3 Month Follow Up Post Last Treatment4.25 ± 1.07
PrimaryPhotographic Evaluation of Wrinkle Severity at 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.

Time frame:
4 Month Follow Up Post Last Treatment
Reported as:
Mean · score on a scale
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment
score on a scale755nm Alexandrite Laser
Photographic Evaluation of Wrinkle Severity at 4 Month Follow Up Post Last Treatment3.9 ± 1.07
PrimaryPhotographic Evaluation of Wrinkle Severity at 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.

Time frame:
6 Month Follow Up Post Last Treatment
Reported as:
Mean · score on a scale
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment
score on a scale755nm Alexandrite Laser
Photographic Evaluation of Wrinkle Severity at 6 Month Follow Up Post Last Treatment4 ± 1.21
Other pre-specifiedSatisfaction Questionnaire
Time frame:
up to 6 months post last treatment

Results for this outcome have not been posted.

Adverse events

Collected over The adverse event data were collected up to 6 months post last treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
755nm Alexandrite Laser0/20 (0%)0/20 (0%)19/20 (95%)
Most frequent other events
Most frequent other events
Event755nm Alexandrite Laser
ErythemaSkin and subcutaneous tissue disorders17/20
EdemaSkin and subcutaneous tissue disorders7/20
painNervous system disorders5/20
ItchingSkin and subcutaneous tissue disorders3/20
BruisingSkin and subcutaneous tissue disorders1/20
DrynessSkin and subcutaneous tissue disorders1/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)755nm Alexandrite Laser
<=18 years0
Between 18 and 65 years20
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)755nm Alexandrite Laser
Female20
Male0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)755nm Alexandrite Laser
Race/Ethnicity — Caucasian19
Race/Ethnicity — Hispanic1
Fitzpatrick Skin Type Score
Fitzpatrick Skin Type Score(Participants)755nm Alexandrite Laser
I4
II15
III1
IV0
V0
VI0
08

Study locations

1 site
  • McDaniel Institute of Anti Aging Research
    Virginia Beach, Virginia 23462, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02091102
Lead sponsor
Cynosure, Inc.
Responsible party
Sponsor
First posted
Mar 19, 2014
Start date
Aug 2013
Primary completion
Jul 2014
Completion
Jul 2014
Results posted
Nov 25, 2020
Last update
Nov 25, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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