Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars (NCT01789346) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
United States20 participantsStarted 2013-02
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of the 532nm potassium titanyl phosphate (KTP) laser in comparison with the 595nm pulsed-dye laser (PDL) for the treatment of fresh surgical scars.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fitzpatrick Skin Type I - IV
* Has postoperative linear scar(s) which is one to twelve months post-surgery.
* Having one scar that measures a minimum of 5 cm in length or two scars (bilateral) each measure a minimum of 2 cm in length.
* Be in good health.
* Must agree not to undergo any other procedure for the treatment of scar during the study.
* Willing to refrain from excess sun exposure and willing to wear sunscreen on the treated scar during the study (including the follow-up period).
* Able to read, understand and sign the Informed Consent Form.
* Willing and able to adhere to the treatment and follow-up schedule, and the post-treatment care instructions.
* Willingness to have digital photographs taken of the treated scar.
* Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
Exclusion Criteria:
* Participation in a study of another device or drug within 6 months prior to enrollment or during the study.
* Having received any prior treatment for the target surgical scar.
* Pregnant and/or breastfeeding.
* Significant concurrent illness, malignant tumors in the target area, acute or chronic skin infection/inflammation, currently using immunosuppressive medications or currently undergoing systemic chemotherapy.
* Current use of any medication known to increase sensitivity to light or taking prescription anticoagulation medica…
What they're measuring
1
Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.