Cutaneous ScarsNCT00544635
The Effect Of Light On Scar Appearance
A study testing light in people with Cutaneous Scars, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Scars
- What is being tested?
- light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have two lesions that have been selected for excision
- Have two cutaneous scars from previous excisions as part of a standard of care
- Subjects are in good health
- Subject has a willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
Who cannot join
- Pregnancy or lactation
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
The goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars.
Read the detailed description
Light would be efficacious in improving scar appearance due to its known effects on wound healing, acne, and its use for skin rejuvenation. Light interacts with cells and stimulates the production of new collagen and elastin. This same energy can be used to inhibit collagen formation and help improve scars.
- Conditions
- Cutaneous Scars
- Being tested
- no intervention, light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionDevice
no intervention
lightDevice
scars will be treated with light
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | scars will be treated with light Receives: Device: light |
| B | Placebo comparator | no intervention Receives: Device: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar vascularity
Measured: 24 weeks
Scar pigmentation
Measured: 24 weeks
Scar thickness
Measured: 24 weeks
Scar length
Measured: 24 weeks
Scar width
Measured: 24 weeks
Scar surface area
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionAug 2006
Why it stopped: Study personnel left institution before study completion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous ScarsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544635
- Sponsor's protocol ID
- 1253-010
- Status last verified
- Jul 2014
- First submitted
- 12 Oct 2007
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Light On Scar Appearance
- ClinicalTrials.gov ID
- NCT00544635
- Acronym / sponsor ID
- 1253-010
- Conditions
- Cutaneous Scars
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study personnel left institution before study completion.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 16 Oct 2007 (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 goal of this project is to examine the ability of light exposure to improve the appearance of cutaneous scars.
Detailed description
Light would be efficacious in improving scar appearance due to its known effects on wound healing, acne, and its use for skin rejuvenation. Light interacts with cells and stimulates the production of new collagen and elastin. This same energy can be used to inhibit collagen formation and help improve scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: lightscars will be treated with light |
| B | Placebo comparator | Device: no interventionno intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have two lesions that have been selected for excision
- Have two cutaneous scars from previous excisions as part of a standard of care
- Subjects are in good health
- Subject has a willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
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 |
|---|---|---|
| no interventionno intervention | Device | B |
| lightscars will be treated with light | Device | A |
Primary outcome
Scar vascularity
Time frame: 24 weeks
Scar pigmentation
Time frame: 24 weeks
Scar thickness
Time frame: 24 weeks
Scar length
Time frame: 24 weeks
Scar width
Time frame: 24 weeks
Scar surface area
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Study personnel left institution before study completion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
Related trials for Cutaneous Scars
RecruitingPhase 2/3
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Burn Scar, Burn Wound
RecruitingObservational study
Autologous Free Dermal Graft Support in Superior Pedicle Vertical Scar Reduction Mammaplasty
Breast Ptosis, Mammaplasty
Active, not recruiting
Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects
Surgical Wound, Wound Heal
Active, not recruitingPhase 2
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
Burns
Active, not recruitingObservational study
Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type
Skin Scarring, Skin Elasticity
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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light in people with Cutaneous Scars, run by Northwestern University 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 4 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: stopped early, as of the sponsor's last update on 29 Jul 2014. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study personnel left institution before study completion.). Results are not available in the source record.
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?
Scar vascularity (time frame: 24 weeks). The study lists 6 primary outcomes in all. 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 29 Jul 2014.