755nm Alex Laser for Treatment of Stretch Marks

Cynosure

Status: Completed

Conditions: Striae

Treatments: Device: 755nm Alexandrite Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT01745211

CYN12-PICO-STRIAE_RG4

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

755nm Alexandrite laser with array handpiece

Experimental group

Description:

Device: 755nm Alexandrite laser with array handpiece

Treatment:

Device: 755nm Alexandrite Laser