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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00970671
Other study ID # 090690
Secondary ID
Status Completed
Phase N/A
First received September 1, 2009
Last updated October 20, 2012
Start date September 2009
Est. completion date December 2010

Study information

Verified date October 2012
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether treatment of fresh surgical scars with a pulsed dye laser using purpura-inducing settings will improve clinical appearance better than one using non-purpura-inducing settings or no treatment.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients requiring Mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5cm in length or more.

- Willing to participate.

- Able to give informed consent

Exclusion Criteria:

- Location of excision or Mohs surgery on the genitals, hands, or feet.

- Fitzpatrick skin type V or VI.

- Prior history of known light sensitivity.

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Laser treatment with Purpuric settings
Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.
Laser treatment with Nonpurpuric settings
Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.
No treatment
No laser treatment

Locations

Country Name City State
United States UCSD Perlman Ambulatory Center - Dermatology clinic La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vancouver Scar Scale score 6weeks, 10weeks, and 18weeks after surgery No
Secondary Subjective rating of pain on scale of 0 to 10 at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery No
Secondary Cosmetic appearance of scar 6weeks, 10 weeks, and 18weeks after surgery No
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