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

• ClinicalTrials.gov Identifier: NCT01754233
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Last Update Posted: October 26, 2020
• Sponsor: Cynosure, Inc.
• Information provided by (Responsible Party): Cynosure, Inc.

Tracking Information

• First Submitted Date: December 18, 2012
• First Posted Date: December 21, 2012
• Last Update Posted Date: October 26, 2020
• Study Start Date: December 2012
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 18, 2012): Photographic Evaluation [ Time Frame: up to 4 months post last treatment ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 18, 2012)

• Reporting of Adverse Events [ Time Frame: up to 4 months post last treatment ]
• Satisfaction Questionnaire [ Time Frame: up to 4 months post treatment ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions
• Official Title: Not Provided
• Brief Summary: The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility
• Condition: Dermal and Epidermal Pigmented Lesions

Intervention

Device: 755nm Alexandrite Laser

755nm Alexandrite Laser for epidermal and dermal pigmented lesions

Study Arms

Experimental: 755nm Alexandrite Laser

755nm Alexandrite Laser

Intervention: Device: 755nm Alexandrite Laser

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2015): 6
• Original Estimated Enrollment (submitted: December 18, 2012): 20
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01754233
• Other Study ID Numbers: CYN12-PICO-PL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Cynosure, Inc.
• Study Sponsor: Cynosure, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Patricia Krantz; Cynosure, Inc.

• PRS Account: Cynosure, Inc.
• Verification Date: October 2020