Surgical Scar Treatment With the Pulsed Dye Laser in Combination With a CO2 Laser

Scars Clinical Trial

Official title:

Multi-Center Study to Compare the Safety and Efficacy of Clearance of Surgical Scars With the Pulse Dye Laser in Combination With a CO2 Laser in a Split Scar Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898350
• Other study ID #: DHF05911
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 13, 2016
• Start date: February 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Syneron Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery.

Description:

Prospective, Randomized, Split lesion treatment with 4 study Arms: 1) treatment with pulsed dye laser (PDL) only, 2) treatment with CO2 laser only, 3) PDL and CO2 laser combined treatment, and 4) split scar combined lasers with an additional single CO2 laser treatment immediately post-surgery vs. no treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Comprehension of, and willingness to sign, the Informed Consent Form.

• Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm.

• Be a healthy male or female of at least 18 years old.

• Fitzpatrick skin type I-V.

• Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions.

• Non pregnant and/or breast feeding, if applicable.

• Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.

• Agree to follow and undergo all study-related procedures.

• Use of daily use of sunblock SPF 30 or higher for duration of the study.

Exclusion Criteria:

1. Pregnant and/or breastfeeding.

2. Fitzpatrick skin type VI.

3. Prior treatment for the surgical scar to be treated in this study.

4. Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.

5. Use of Isotretinoin or other systemic retinoids within the past 6 months.

6. Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months.

7. Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges.

8. Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.

9. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.

10. Having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study.

11. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study.

12. Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment.

13. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scars

Intervention

Device:
• Pulsed dye laser treatment
Scar minimization with Pulsed dye laser treatment on suture removal day
• CO2 laser treatment
Scar minimization with CO2 laser treatment on suture removal day
• Combined PDL and CO2 laser treatment
Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day
• Split PDL and CO2 Laser treatment
Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day

Locations

Country	Name	City	State
United States	AboutSkin, Dermatology and Derm Surgery PC	Englewood	Colorado
United States	Laser & Skin Surgery Center of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Syneron Medical

Country where clinical trial is conducted

United States, 

References & Publications (3)

Alster T. Laser scar revision: comparison study of 585-nm pulsed dye laser with and without intralesional corticosteroids. Dermatol Surg. 2003 Jan;29(1):25-9. — View Citation

Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3. — View Citation

Weiss ET, Chapas A, Brightman L, Hunzeker C, Hale EK, Karen JK, Bernstein L, Geronemus RG. Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement. Arch Dermatol. 2010 Feb;146(2):133-40. doi: 10.1001/archdermatol.2009.358. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and severity of adverse events	Number and severity of adverse events	Baseline and up to 3 months after treatment	Yes
Primary	Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline	Blinded review of 7-point Global Evaluation Response (GER) scale	Baseline, 3 months after final treatment	No
Secondary	Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline	Investigator review of VSS - The VSS assesses four variables: vascularity, pigmentation, pliability, and height of the scar, to provide an overall score from 0 (normal) to 13 (severe).	Baseline, 3 months after final treatment	No