Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions
This study is currently recruiting participants.
Verified December 2012 by Cynosure, Inc.
Sponsor:
Cynosure, Inc.
Information provided by (Responsible Party):
Cynosure, Inc.
ClinicalTrials.gov Identifier:
NCT01754233
First received: December 18, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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Purpose
The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.
| Condition | Intervention |
|---|---|
|
Dermal and Epidermal Pigmented Lesions |
Device: 755nm Alexandrite Laser |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Further study details as provided by Cynosure, Inc.:
Primary Outcome Measures:
- Photographic Evaluation [ Time Frame: up to 4 months post last treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reporting of Adverse Events [ Time Frame: up to 4 months post last treatment ] [ Designated as safety issue: Yes ]
- Satisfaction Questionnaire [ Time Frame: up to 4 months post treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 755nm Alexandrite Laser
755nm Alexandrite Laser
|
Device: 755nm Alexandrite Laser
755nm Alexandrite Laser for epidermal and dermal pigmented lesions
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754233
Contacts
| Contact: Kathleen Petrell | 617.848.1638 | kpetrell@skincarephysicians.ne |
Locations
| United States, Massachusetts | |
| Skin Care Physicians | Recruiting |
| Chestnut Hill, Massachusetts, United States, 02467 | |
Sponsors and Collaborators
Cynosure, Inc.
Investigators
| Study Director: | Patricia Krantz | Cynosure, Inc. |
More Information
No publications provided
| Responsible Party: | Cynosure, Inc. |
| ClinicalTrials.gov Identifier: | NCT01754233 History of Changes |
| Other Study ID Numbers: | CYN12-PICO-PL |
| Study First Received: | December 18, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 21, 2013