Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars

• Sponsor: Cynosure, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01813786
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.

Condition or Disease	Intervention/Treatment	Phase
Scars	Device: 755nm Alexandrite Laser with handpiece 2; Device: 755nm Alexandrite Laser with handpiece 1; Device: 755nm Alexandrite Laser with handpiece 3	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Device Feasibility
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 755nm Alexandrite Laser with Handpiece 2 Focusing energy on skin	Device: 755nm Alexandrite Laser with handpiece 2; Focusing energy on skin
Experimental: 755nm Alexandrite Laser with handpiece 3 Focusing energy on skin	Device: 755nm Alexandrite Laser with handpiece 3; Focusing energy on skin
Experimental: 755nm Alexandrite laser with handpiece 1 Focusing energy on skin	Device: 755nm Alexandrite Laser with handpiece 1; focusing energy at skin surface

Outcome Measures

Primary Outcome Measures

1. Subject Biopsy Sampling [3 months post last treatment]

   Histological examination of tissue samples will be compared between baseline and 3 months post treatment.

Secondary Outcome Measures

1. Photographic evaluation as a measure of improvement. [up to 3 months post last treatment]

   2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement.

2. Subject Biopsy Sampling [2 weeks post treatment]

   Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment.

3. Subject Biopsy Sampling [1 month post treatment]

   Histological examination of tissue samples will be compared between baseline and 1 month post treatment.

Other Outcome Measures

1. Number of participants with adverse events as a measure of safety and tolerability [up to 3 months post last 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 scars not including atrophic scars 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 biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.

5. Has Fitzpatrick skin types I 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 a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).

5. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.

6. 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.

7. The subject has used Accutane within 6 months prior to enrollment.

8. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.

9. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).

10. The subject has a history of keloids.

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. The subjects has an allergy to lidocaine and epinephrine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Laser & Skin Surgery Center of New York	New York	New York	United States	10016

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: NCT01813786
• Other Study ID Numbers: CYN12-PICO-CAPHST-07
• First Posted: Mar 19, 2013
• Last Update Posted: Oct 28, 2020
• Last Verified: Oct 1, 2020

Study Results

No Results Posted as of Oct 28, 2020