- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01754233
Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions
October 23, 2020 updated by: Cynosure, Inc.
The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Chestnut Hill, Massachusetts, United States, 02467
- Skin Care Physicians
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 755nm Alexandrite Laser
|
755nm Alexandrite Laser for epidermal and dermal pigmented lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Photographic Evaluation
Time Frame: up to 4 months post last treatment
|
up to 4 months post last treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reporting of Adverse Events
Time Frame: up to 4 months post last treatment
|
up to 4 months post last treatment
|
Satisfaction Questionnaire
Time Frame: up to 4 months post treatment
|
up to 4 months post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (ACTUAL)
October 1, 2014
Study Completion (ACTUAL)
October 1, 2014
Study Registration Dates
First Submitted
December 18, 2012
First Submitted That Met QC Criteria
December 18, 2012
First Posted (ESTIMATE)
December 21, 2012
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2020
Last Update Submitted That Met QC Criteria
October 23, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- CYN12-PICO-PL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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