Striae Clinical Trial
Verified date | January 2021 |
Source | Cynosure, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Evaluate the safety and efficacy of the bilateral treatment of striae using a 755nm Alexandrite laser.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Laser & Skin Surgery Center of New York | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Cynosure, Inc. |
United States,
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 |
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