AcnePhase 1/2NCT00585286
Fractional Resurfacing Device for Treatment of Acne Scarring
A Phase 1/2 study testing 10,600 nm fractional carbon dioxide laser system in people with Acne and Scar, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- 10,600 nm fractional carbon dioxide laser system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jul 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have Fitzpatrick skin type I-V. (Type I is blonde/red hair with freckles and Type V are Hispanics and lighter African Americans.)
- Are male or female.
- Are between 18 and 75 years of age.
- Have moderate to severe acne scarring. Acne scarring will be assessed with the Acne Scar Severity Scale. Subjects will be eligible for treatment if the area to be treated is scored as having an Acne Scar Severity Score > 4 according to the Acne Scar Severity Scale (0-9).
- Are able to read, understand, and sign the Informed Consent.
- Are willing and able to comply with all follow-up requirements for a minimum of 8 months.
Who cannot join
- Have had active localized or systemic infections within 6 months of enrollment
- Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
- Have immunocompromised status (inability to resist infection, etc.)
- Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Have taken Accutane within 12 months of enrollment
- Are allergic to lidocaine (skin numbing agent)
- Are allergic to Valtrex (an anti-viral medication)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Irvine Dermatology Clinical Research Center
Irvine, California, 92697
About this study
Official title: Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring
The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces).
Read the detailed description
Thirty subjects between two research locations with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved 10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at 1 month and 3 months post-treatment.
Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation.
The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation
- Being tested
- 10,600 nm fractional carbon dioxide laser system
- Keywords
- acne vulgaris, scarring, laser
- Medical subject headings
- Acne Vulgaris, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10,600 nm fractional carbon dioxide laser systemDevice
Also called Fraxel Re:pair laser
1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
| Study group | Role | What they receive |
|---|---|---|
| Fractional carbon dioxide laser system | Experimental | Thirty total healthy subjects from two research centers with skin type I-IV of moderate to severe acne scarring received treatment with the 10,600 nm fractional carbon dioxide laser system. Receives: Device: 10,600 nm fractional carbon dioxide laser system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Improvement of Acne Scarring
Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Measured: Baseline, 1 month and 3 months post-treatment
Average Improvement in Surface Texture
Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Measured: Baseline, 1 month and 3 months post-treatment
Degree of Atrophy
Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Measured: Baseline, 1 month and 3 months post-treatment
Secondary outcomes (1)
Pain Tolerance
The average pain score reported over all three treatments was 5.67, corresponding to "moderate" pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being "no pain" and 10 being "worst pain imaginable." All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy.
Measured: At treatment visit (up to 3 visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Reliant Technologies, Inc. Mountain View, CA, University of Minnesota
- Responsible party
- Principal investigator, Christopher Zachary, University of California, Irvine
- Investigators
- Christopher B Zachary, MBBS, FRCP, Principal investigator, University of California, IrvineBrian D Zelickson, MD, Principal investigator, Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585286
- Sponsor's protocol ID
- 2006-5328
- Status last verified
- Dec 2013
- First submitted
- 26 Dec 2007
- Last updated
- 15 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring
- ClinicalTrials.gov ID
- NCT00585286
- Acronym / sponsor ID
- 2006-5328
- Keywords
- acne vulgaris, scarring, laser
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Reliant Technologies, Inc. Mountain View, CA, University of Minnesota
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 2 Dec 2013
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 research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces).
Detailed description
Thirty subjects between two research locations with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved 10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at 1 month and 3 months post-treatment.
Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation.
The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional carbon dioxide laser system | Experimental | Device: 10,600 nm fractional carbon dioxide laser systemThirty total healthy subjects from two research centers with skin type I-IV of moderate to severe acne scarring received treatment with the 10,600 nm fractional carbon dioxide laser system. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have Fitzpatrick skin type I-V. (Type I is blonde/red hair with freckles and Type V are Hispanics and lighter African Americans.)
- Are male or female.
- Are between 18 and 75 years of age.
- Have moderate to severe acne scarring. Acne scarring will be assessed with the Acne Scar Severity Scale. Subjects will be eligible for treatment if the area to be treated is scored as having an Acne Scar Severity Score > 4 according to the Acne Scar Severity Scale (0-9).
- Are able to read, understand, and sign the Informed Consent.
Key exclusion criteria (7 listed)
- Have had active localized or systemic infections within 6 months of enrollment
- Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
- Have immunocompromised status (inability to resist infection, etc.)
- Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Have taken Accutane within 12 months of enrollment
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 |
|---|---|---|
| 10,600 nm fractional carbon dioxide laser systemAlso: Fraxel Re:pair laser1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2 | Device | Fractional carbon dioxide laser system |
Primary outcome
Overall Improvement of Acne Scarring
Time frame: Baseline, 1 month and 3 months post-treatment
Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Average Improvement in Surface Texture
Time frame: Baseline, 1 month and 3 months post-treatment
Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Degree of Atrophy
Time frame: Baseline, 1 month and 3 months post-treatment
Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
1 secondary outcome
Pain Tolerance
Time frame: At treatment visit (up to 3 visits)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of California, Irvine Department of Dermatology Clinical ResearchLink provided by the sponsor.
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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.
Christopher B Zachary, MBBS, FRCP principal investigator
University of California, Irvine
Brian D Zelickson, MD principal investigator
Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 10,600 nm fractional carbon dioxide laser system in people with Acne and Scar, run by University of California, Irvine 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 6 inclusion and 7 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 15 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Improvement of Acne Scarring (time frame: Baseline, 1 month and 3 months post-treatment). The study lists 3 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 15 Jan 2014.