ScarNCT00970671
Treatment of Surgical Scars Using the Pulsed Dye Laser
A study testing Laser treatment with Purpuric settings, Laser treatment with Nonpurpuric settings and No treatment in people with Scar and Laser Therapy, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Scar, Laser Therapy
- What is being tested?
- Laser treatment with Purpuric settings, Laser treatment with Nonpurpuric settings and No treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Location of excision or Mohs surgery on the genitals, hands, or feet.
- Fitzpatrick skin type V or VI.
- Prior history of known light sensitivity.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Perlman Ambulatory Center - Dermatology clinic
La Jolla, California, 92037
About this study
Official title: Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study
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.
- Conditions
- Scar, Laser Therapy
- Being tested
- Laser treatment with Purpuric settings, Laser treatment with Nonpurpuric settings, No treatment
- Keywords
- scar, laser therapy, lasers, pulsed dye
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatment with Purpuric settingsOther
Also called Pulsed dye laser, 595nm VBeam, Candela
Pulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec.
Laser treatment with Nonpurpuric settingsOther
Also called Pulsed dye laser, 595nm VBeam, Candela
Pulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec.
No treatmentOther
No laser treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale score
Measured: 6weeks, 10weeks, and 18weeks after surgery
Secondary outcomes (2)
Subjective rating of pain on scale of 0 to 10
Measured: at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery
Cosmetic appearance of scar
Measured: 6weeks, 10 weeks, and 18weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Akiko Gladsjo, University of California, San Diego
- Investigators
- Julie A Gladsjo, MD PhD, Principal investigator, University of California, San DiegoS. Brian Jiang, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970671
- Sponsor's protocol ID
- 090690
- Status last verified
- Oct 2012
- First submitted
- 1 Sep 2009
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Surgical Scars With the 595nm Pulsed Dye Laser Using Purpuric and Nonpurpuric Parameters: A Comparative Study
- ClinicalTrials.gov ID
- NCT00970671
- Acronym / sponsor ID
- 090690
- Conditions
- Scar, Laser Therapy
- Keywords
- scar, laser therapy, lasers, pulsed dye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Location of excision or Mohs surgery on the genitals, hands, or feet.
- Fitzpatrick skin type V or VI.
- Prior history of known light sensitivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser treatment with Purpuric settingsAlso: Pulsed dye laser, 595nm VBeam, CandelaPulsed dye laser treatment at purpuric settings with pulse duration of 1.5msec. | Other | – |
| Laser treatment with Nonpurpuric settingsAlso: Pulsed dye laser, 595nm VBeam, CandelaPulsed dye laser treatment with nonpurpuric settings with pulse duration 10msec. | Other | – |
| No treatmentNo laser treatment | Other | – |
Primary outcome
Vancouver Scar Scale score
Time frame: 6weeks, 10weeks, and 18weeks after surgery
2 secondary outcomes
Subjective rating of pain on scale of 0 to 10
Time frame: at each treatment visit: 2weeks, 6weeks, and 10weeks after surgery
Cosmetic appearance of scar
Time frame: 6weeks, 10 weeks, and 18weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie A Gladsjo, MD PhD principal investigator
University of California, San Diego
S. Brian Jiang, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment with Purpuric settings, Laser treatment with Nonpurpuric settings and No treatment in people with Scar and Laser Therapy, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale score (time frame: 6weeks, 10weeks, and 18weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.