N/A
N=33
Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars
Scars
Bottom Line
View on ClinicalTrials.gov: NCT01811030 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Photographic Evaluation of Scar Clearance — 1.82 score on a scale
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
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Photographic Evaluation of Scar Clearance |
2.28 | — |
| PRIMARY Photographic Evaluation of Scar Clearance |
2.28 | — |
Summary
Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.
Eligibility Criteria
Inclusion Criteria
- Is a healthy male or female between 18 and 85 years old.
- Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )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 (NCT01811030). 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.