ScarsNCT01813786
Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars
A study testing 755nm Alexandrite Laser with handpiece 2, 755nm Alexandrite Laser with handpiece 1 and 755nm Alexandrite Laser with handpiece 3 in people with Scars, run by Cynosure, Inc. at 1 site in United States.
Trial summary
Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Scars
- What is being tested?
- 755nm Alexandrite Laser with handpiece 2, 755nm Alexandrite Laser with handpiece 1 and 755nm Alexandrite Laser with handpiece 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Dec 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a healthy male or female between 18 and 85 years old
- Has unwanted scars not including atrophic scars and wishes to undergo laser treatments.
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
- Has Fitzpatrick skin types I to IV.
Who cannot join
- The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- The subject has active or localized systemic infections.
- The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
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- The subject has used Accutane within 6 months prior to enrollment.
- The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
- The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
- The subject has a history of keloids.
- The subject has evidence of compromised wound healing.
- The subject has a history of squamous cell carcinoma or melanoma.
- The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- The subjects has an allergy to lidocaine and epinephrine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser & Skin Surgery Center of New York
New York, New York, 10016
About this study
Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.
- Conditions
- Scars
- Being tested
- 755nm Alexandrite Laser with handpiece 2, 755nm Alexandrite Laser with handpiece 1, 755nm Alexandrite Laser with handpiece 3
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
755nm Alexandrite Laser with handpiece 2Device
Focusing energy on skin
755nm Alexandrite Laser with handpiece 1Device
focusing energy at skin surface
755nm Alexandrite Laser with handpiece 3Device
Focusing energy on skin
| Study group | Role | What they receive |
|---|---|---|
| 755nm Alexandrite Laser with Handpiece 2 | Experimental | Focusing energy on skin Receives: Device: 755nm Alexandrite Laser with handpiece 2 |
| 755nm Alexandrite Laser with handpiece 3 | Experimental | Focusing energy on skin Receives: Device: 755nm Alexandrite Laser with handpiece 3 |
| 755nm Alexandrite laser with handpiece 1 | Experimental | Focusing energy on skin Receives: Device: 755nm Alexandrite Laser with handpiece 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Biopsy Sampling
Histological examination of tissue samples will be compared between baseline and 3 months post treatment.
Measured: 3 months post last treatment
Secondary outcomes (3)
Photographic evaluation as a measure of improvement.
2D photographs to be taken at each visit and assessed at the end of the study by 2-3 blinded assessors for improvement.
Measured: up to 3 months post last treatment
Subject Biopsy Sampling
Histological examination of tissue samples will be compared between baseline and 2 weeks post treatment.
Measured: 2 weeks post treatment
Subject Biopsy Sampling
Histological examination of tissue samples will be compared between baseline and 1 month post treatment.
Measured: 1 month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Krantz, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01813786
- Sponsor's protocol ID
- CYN12-PICO-CAPHST-07
- Status last verified
- Oct 2020
- First submitted
- 12 Mar 2013
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of the 755nm Alexandrite Laser With Handpiece for the Treatment of Scars
- ClinicalTrials.gov ID
- NCT01813786
- Acronym / sponsor ID
- CYN12-PICO-CAPHST-07
- Conditions
- Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Mar 2013 (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.
Compare efficacy and safety of handpieces on the 755nm Alexandrite laser for the treatment of scars.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 755nm Alexandrite Laser with Handpiece 2 | Experimental | Device: 755nm Alexandrite Laser with handpiece 2Focusing energy on skin |
| 755nm Alexandrite Laser with handpiece 3 | Experimental | Device: 755nm Alexandrite Laser with handpiece 3Focusing energy on skin |
| 755nm Alexandrite laser with handpiece 1 | Experimental | Device: 755nm Alexandrite Laser with handpiece 1Focusing energy on skin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is a healthy male or female between 18 and 85 years old
- Has unwanted scars not including atrophic scars and wishes to undergo laser treatments.
- Is willing to consent to participate in the study.
- Is willing to comply with all requirements of the study including biopsies, being photographed, following post treatment care and attending all treatment and follow up visits.
- Has Fitzpatrick skin types I to IV.
Key exclusion criteria (14 listed)
- The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- The subject is hypersensitive to light exposure OR takes photo sensitized medication.
- The subject has active or localized systemic infections.
- The subject has a coagulation disorder or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy {greater than 81 mg per day}).
- The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
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 |
|---|---|---|
| 755nm Alexandrite Laser with handpiece 2Focusing energy on skin | Device | 755nm Alexandrite Laser with Handpiece 2 |
| 755nm Alexandrite Laser with handpiece 1focusing energy at skin surface | Device | 755nm Alexandrite laser with handpiece 1 |
| 755nm Alexandrite Laser with handpiece 3Focusing energy on skin | Device | 755nm Alexandrite Laser with handpiece 3 |
Primary outcome
Subject Biopsy Sampling
Time frame: 3 months post last treatment
Histological examination of tissue samples will be compared between baseline and 3 months post treatment.
3 secondary outcomes
Photographic evaluation as a measure of improvement.
Time frame: up to 3 months post last treatment
Subject Biopsy Sampling
Time frame: 2 weeks post treatment
Subject Biopsy Sampling
Time frame: 1 month post treatment
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 28 Oct 2020.
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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.
Patricia Krantz study director
Cynosure, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 755nm Alexandrite Laser with handpiece 2, 755nm Alexandrite Laser with handpiece 1 and 755nm Alexandrite Laser with handpiece 3 in people with Scars, run by Cynosure, Inc. 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 5 inclusion and 14 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 28 Oct 2020. 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?
Subject Biopsy Sampling (time frame: 3 months post last treatment). 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 28 Oct 2020.