Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars

Not Applicable

Completed

• Conditions: Scars
• Interventions: Device: 755nm Alexandrite Laser

• Registration Number: NCT01811030
• Lead Sponsor: Cynosure, Inc.

Brief Summary

Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2020-10-19
• Results First Submitted QC: 2020-11-24
• Status Verified: 2020-12
• Results First Posted: 2020-12-19
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. Is a healthy male or female between 18 and 85 years old.
2. Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.
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

Exclusion Criteria

1. Is hypersensitive to light exposure.
2. Has active localized or systemic infection.
3. Is taking medication(s) for which sunlight is a contraindication.
4. Has a history of squamous cell carcinoma or melanoma.
5. Has a history of keloid scarring.
6. Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
7. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
8. Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
9. Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
10. Has any other reason determined by the physician to be ineligible to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
755nm Alexandrite Laser	755nm Alexandrite Laser	755nm Alexandrite Laser

Primary Outcome Measures

Name	Time	Method
Photographic Evaluation of Scar Clearance	3 Months Post Last Treatment	The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.

Trial Locations

Locations (1)

Laser & Skin Surgery Center of New York; 🇺🇸 New York, New York, United States