Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

NeuroTherapia, Inc.

Status: Terminated

Conditions: Abdominoplasty Scars

Treatments: Device: combined PDL and Affirm Lasers; Device: Affirm Laser; Device: pulsed dye laser; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00735254

08-352

Details and patient eligibility

About

The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar that can benefit from laser therapy. Redness and the appearance of small blood vessels near the surface of the skin (telangiectasias) develop in such scars as part of the normal healing process and usually spontaneously remit, but often slowly and incompletely. In many cases, lasers can accelerate the clearing of this redness and also improve scar texture.

Full description

In summary, we will perform a total of three laser treatments. A personal interview, clinical examination, and a photograph will be taken at each visit. At the end of the three treatments, a final personal interview, clinical evaluation and photograph will be taken to document the effects of the laser treatments. At the end of the study, the patient will have the option to receive two additional laser treatments four weeks apart, also at no cost, to the entire scar.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 years and older
• No significant medical illness
• Surgical procedure that involves closure of the transverse abdominal incision performed in the department of dermatology and plastic surgery at the Cleveland Clinic main campus.
• Subjects with the willingness and ability to understand and provide informed consent

Exclusion criteria

• Under 18 years of age
• Pregnancy or Lactation
• Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
• Subjects with liver/kidney disease, diabetes mellitus, hypertension, connective tissue disease or who are immunocompromised
• Subjects with a known susceptibility to keloid formation or hypertrophic scarring
• Subjects who are unable to understand the protocol or to give informed consent
• Subjects with mental illness
• Subjects with obvious non-healing wound

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

3 participants in 4 patient groups, including a placebo group

Pulsed dye laser

Active Comparator group

Description:

PDL Patient will be have scar treated with pulsed dye laser.

Treatment:

Device: pulsed dye laser

Affirm laser

Active Comparator group

Description:

Patient will be have scar treated with Affirm Laser

Treatment:

Device: Affirm Laser

combined PDL and Affirm Lasers

Active Comparator group

Description:

Patient will be have scar treated with combined Affirm + PDL

Treatment:

Device: combined PDL and Affirm Lasers

Placebo

Placebo Comparator group

Description:

Patient will be have scar treated with Placebo

Treatment:

Other: Placebo