Scar Clinical Trial
Official title:
Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.
NCT number | NCT01789346 |
Other study ID # | C-12-EV03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2013 |
Est. completion date | December 2014 |
Verified date | January 2023 |
Source | Cutera Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2014 |
Est. primary completion date | March 26, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 medication. - History of abnormal or delayed wound healing, keloid formation or pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. - History of malignant skin disease, immune deficiency disorders, coagulation disorders, seizure disorders due to light, or diseases stimulated by heat, unless prophylactic measures taken prior to treatment. - Systemic use of isotretinoin within 6 months or corticosteroids within 12 months of study participation. - Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus. - Current smoker or history of smoking within 12 months of study participation. |
Country | Name | City | State |
---|---|---|---|
United States | Washington Institute of Dermatologic Laser Surgery | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Cutera Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms. | Improvement in surgical scar of 532 nm KTP and 595 nm PDL treatment arms at 12 weeks post-final treatment (compared to baseline) as assessed by blinded independent reviewers Physician's Global Assessment (min=0; max=3) Higher scores mean better outcome | 12-weeks post-final laser treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03646955 -
Partial Breast Versus no Irradiation for Women With Early Breast Cancer
|
N/A | |
Completed |
NCT01706848 -
Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
|
N/A | |
Recruiting |
NCT01177358 -
Botox in the Healing of Surgical Wounds of the Neck
|
Phase 2 | |
Terminated |
NCT01459666 -
Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer
|
Phase 4 | |
Completed |
NCT00970671 -
Treatment of Surgical Scars Using the Pulsed Dye Laser
|
N/A | |
Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
Completed |
NCT05293652 -
Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar
|
N/A | |
Recruiting |
NCT03406143 -
Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
|
N/A | |
Completed |
NCT05527756 -
Evaluation of the Cosmetic Outcomes of Totally Endoscopic Cardiac Surgery
|
||
Completed |
NCT02886988 -
Early Postoperative Prevention and Treatment of Median Sternotomy Scars With Botulinum Toxin Type A Injection
|
Phase 2/Phase 3 | |
Completed |
NCT05618912 -
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
|
N/A | |
Recruiting |
NCT05408117 -
Impact of Suture Type on Pigment Disturbances in Patients of Skin of Color
|
N/A | |
Completed |
NCT04169438 -
Pilot Study Investigating a Restorative Wound Care Cream Together With Petrolatum on Surgical Excisions
|
N/A | |
Terminated |
NCT02520557 -
An Exploratory Study of Genetic and Clinical Factors for Serious Skin Reactions Among Users of Eslicarbazepine Acetate
|
||
Not yet recruiting |
NCT04621994 -
Cesarean Wound Closure: Dermabond Versus Steri Strips
|
N/A | |
Withdrawn |
NCT03395678 -
Acne Scarring in Skin of Color: Laser vs Microneedling
|
N/A | |
Completed |
NCT02744950 -
Comparison of Scar Results and Time for Closures of Scalp Defects Via Pulley Sutures or Layered Repairs
|
N/A | |
Not yet recruiting |
NCT01005992 -
Fractional Photothermolysis for the Treatment of Burn Scars
|
Phase 1 | |
Completed |
NCT04870008 -
Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm)
|
N/A | |
Recruiting |
NCT04506255 -
Silicone Taping for the Improvement of Abdominal Donor Site Scars
|
N/A |