N/A
N=45
755nm Alex Laser for Treatment of Stretch Marks
Striae
Bottom Line
View on ClinicalTrials.gov: NCT01745211 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Photographic Evaluation of Striae Clearance — 36; 17; 11 areas with striation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 755nm Alexandrite Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cynosure, Inc.
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Photographic Evaluation of Striae Clearance |
36; 17; 11 | — |
Summary
Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.
Eligibility Criteria
Inclusion Criteria
- Is a healthy male or female between 18 and 85 years old.
- Has unwanted striae and wishes to undergo laser treatments to remove or improve them.
- Is willing to consent to participate in the study.
- 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
- Is hypersensitive to light exposure.
- Has active localized or systemic infection.
- Is taking medication(s) for which sunlight is a contraindication.
- Has a history of squamous cell carcinoma or melanoma.
- Has a history of keloid scarring.
- 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.
- Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
- Has any other reason determined by the physician to be ineligible to participate in the study.
Data sourced from ClinicalTrials.gov (NCT01745211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.