Clinical trial NCT01789346: Pilot Study of a Novel 532nm KTP Laser for the Treatment of Fresh Surgical Scars
Official title: Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Surgical Scar
Cicatrix
Cicatrix, Hypertrophic
Keloid
Keywords: Scar
Scars
Surgical Scar
Surgical Scars
Cicatrix
Hypertrophic Cicatrix
Keloid
Hypertrophic Scar
Surgical Incision
Scarring
Abdominoplasty
Tummy Tuck
Augmentation Mammoplasty
Breast Augmentation
Thyroidectomy
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Randomized, Controlled, Open-Label Pilot Study of a Novel 532 nm KTP Laser for the Treatment of Fresh Surgical Scars. This is a single-center prospective, randomized, open-label, pilot study of a novel 532 nm KTP Laser in comparison with the 595nm pulsed-dye laser (PDL) in up to 20 subjects who have had a fresh surgical scar acquired within one to twelve months of the screening visit.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Surgical Scar of Treatment (532nm KTP Laser) and Active Control (595nm PDL) Treatment Arms.
timeFrame: 12-weeks post-final laser treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Institute of Dermatologic Laser Surgery
state: District of Columbia
Study officials:
affiliation: Washington Institute of Dermatologic Laser Surgery
name: Tina Alster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington Institute of Dermatologic Laser Surgery
name: Elizabeth Tanzi, MD
role: PRINCIPAL_INVESTIGATOR
References: