Chestnut Hill, Massachusetts 02467

  • Dermal and Epidermal Pigmented Lesions

Purpose:

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


Criteria:

Inclusion Criteria: 1. Is a healthy male or female between 18 and 85 years old 2. Has unwanted dermal and/or epidermal pigmented lesions or desires skin toning and wishes to undergo laser treatments. 3. Is willing to consent to participate in the study. 4. 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. 5. Has Fitzpatrick skin types III to IV. 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 any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. 5. 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. 6. The subject has used Accutane within 6 months prior to enrollment. 7. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial. 8. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate). 9. The subjects had prior treatment with laser or other devices in the treatment area within 3 months. 10. The subject has a history of keloids or hypertrophic scarring. 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. 14. Is allergic to topical lidocaine or topical steroids.


Study is Available At:


Original ID:

CYN12-PICO-PL


NCT ID:

NCT01754233


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Cynosure, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

6


Enrollment Type:

Actual


Overall Contact Information

Official Name:Patricia Krantz
Study Director
Cynosure, Inc.

Study Dates

Start Date:December 2012
Completion Date:October 2014
Completion Type:Actual
Primary Completion Date:October 2014
Primary Completion Type:Actual
Verification Date:October 2020
Last Changed Date:October 23, 2020
First Received Date:December 18, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Satisfaction Questionnaire
Time Frame:up to 4 months post treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reporting of Adverse Events
Time Frame:up to 4 months post last treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Photographic Evaluation
Time Frame:up to 4 months post last treatment
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:755nm Alexandrite Laser
Description:755nm Alexandrite Laser for epidermal and dermal pigmented lesions
Arm Name:755nm Alexandrite Laser

Study Arms

Study Arm Type:Experimental
Arm Name:755nm Alexandrite Laser
Description:755nm Alexandrite Laser

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Cynosure, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 29, 2021

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