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

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01754233
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dermal and Epidermal Pigmented Lesions	Device: 755nm Alexandrite Laser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 755nm Alexandrite Laser 755nm Alexandrite Laser	Device: 755nm Alexandrite Laser; 755nm Alexandrite Laser for epidermal and dermal pigmented lesions

Outcome Measures

Primary Outcome Measures

1. Photographic Evaluation [up to 4 months post last treatment]

Secondary Outcome Measures

1. Reporting of Adverse Events [up to 4 months post last treatment]

2. Satisfaction Questionnaire [up to 4 months post treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skin Care Physicians	Chestnut Hill	Massachusetts	United States	02467

Sponsors and Collaborators

• Cynosure, Inc.

Investigators

• Study Director: Patricia Krantz, Cynosure, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cynosure, Inc.
• ClinicalTrials.gov Identifier: NCT01754233
• Other Study ID Numbers: CYN12-PICO-PL
• First Posted: Dec 21, 2012
• Last Update Posted: Oct 26, 2020
• Last Verified: Oct 1, 2020

Study Results

No Results Posted as of Oct 26, 2020