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

Scars Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813786
• Other study ID #: CYN12-PICO-CAPHST-07
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2020
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scars

Intervention

Device:
• 755nm Alexandrite Laser with handpiece 2
Focusing energy on skin
• 755nm Alexandrite Laser with handpiece 1
focusing energy at skin surface
• 755nm Alexandrite Laser with handpiece 3
Focusing energy on skin

Locations

Country	Name	City	State
United States	Laser & Skin Surgery Center of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events as a measure of safety and tolerability		up to 3 months post last treatment
Primary	Subject Biopsy Sampling	Histological examination of tissue samples will be compared between baseline and 3 months post treatment.	3 months post last treatment
Secondary	Photographic evaluation as a measure of improvement.	2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement.	up to 3 months post last treatment
Secondary	Subject Biopsy Sampling	Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment.	2 weeks post treatment
Secondary	Subject Biopsy Sampling	Histological examination of tissue samples will be compared between baseline and 1 month post treatment.	1 month post treatment