755nm Alex Laser for Treatment of Stretch Marks

Striae Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745211
• Other study ID #: CYN12-PICO-STRIAE_RG4
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2021
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2013
• Est. primary completion date: November 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 striae 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.

Related Conditions & MeSH terms

• Striae

Intervention

Device:
• 755nm Alexandrite Laser
755nm Alexandrite laser with array handpiece

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
Primary	Photographic Evaluation of Striae Clearance	The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.	Follow Up Between 1 and 3 Months Post Last Treatment