PhotodamageNCT00955461
Comparison of the RevLite Electro-optic Q-Switched Neodymium-doped Yttrium Aluminium Garnet (EO QS Nd:YAG) Laser to a Fractionated Laser System
A study testing RevLite laser treatment and Fractionated Laser treatment in people with Photodamage and Irregular Pigmentation, run by ConBio, a Cynosure Company at 1 site in United States.
Trial summary
The purpose of this study is to compare the results of treatment between the side of the face treated with the RevLite Laser and the side of the face treated with a fractionated laser system. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Photodamage, Irregular Pigmentation, Acne Scars
- What is being tested?
- RevLite laser treatment and Fractionated Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 2012
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fitzpatrick Skin Type I-VI and Wrinkle Class I
- Between the ages of 25-65
- Evidence of bilateral dyschromia
Who cannot join
- Pregnant, lactating, or is planning to become pregnant
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical or systemic therapy
- coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
- currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
Show all 24Show fewer
- unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
- Accutane within 6 months
- need to be exposed to artificial tanning devices or excessive sunlight during the trial
- prior treatment with parenteral gold therapy
- Diabetes Type 1 or 2
- does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected fillers/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study
- artificial tanning within 1 month
- (micro)dermabrasion within 3 months
- other laser or IPL to the face within 6 months
- chemical peel within 1 month
- injectable fillers within 3 months
- topical retinoids within 3 months
- over-the-counter anti-aging products (e.g., those containing peptides, hyaluronic acid, or agents specifically advertised as having anti-aging or age-inhibiting properties) within 1 month
- history of keloids or hypertrophic scarring
- evidence of compromised wound healing
- history of cold sores, chickenpox or shingles and unwilling to take a prophylactic course of Valtrex/acyclovir
- allergy to acyclovir
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market, Randomized, Single Blind, Split-Faced Comparison of the RevLite Nd:YAG Laser System Versus a Non-Ablative, Mid Infra-red, Fractionated Type Laser System for Skin Rejuvenation
The purpose of this study is to compare the results of treatment between the side of the face treated with the RevLite Laser and the side of the face treated with a fractionated laser system.
- Conditions
- Photodamage, Irregular Pigmentation, Acne Scars
- Being tested
- RevLite laser treatment, Fractionated Laser treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevLite laser treatmentProcedure or surgery
Electro-optic Q-Switched Nd: YAG Laser treatment
Fractionated Laser treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Split-Face Comparison of an Electro-optic Q-Switched Nd: YAG Laser to a Fractionated Laser Receives: Procedure: RevLite laser treatment; Procedure: Fractionated Laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars
Measured: 3 and 6 months post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotodamageStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConBio, a Cynosure Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Sadick, MD, Principal investigator, Sadick Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955461
- Sponsor's protocol ID
- C66-07-F
- Status last verified
- Nov 2012
- First submitted
- 6 Aug 2009
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market, Randomized, Single Blind, Split-Faced Comparison of the RevLite Nd:YAG Laser System Versus a Non-Ablative, Mid Infra-red, Fractionated Type Laser System for Skin Rejuvenation
- ClinicalTrials.gov ID
- NCT00955461
- Acronym / sponsor ID
- C66-07-F
- Conditions
- Photodamage, Irregular Pigmentation, Acne Scars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ConBio, a Cynosure CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Aug 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 compare the results of treatment between the side of the face treated with the RevLite Laser and the side of the face treated with a fractionated laser system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Procedure: RevLite laser treatment, Procedure: Fractionated Laser treatmentSplit-Face Comparison of an Electro-optic Q-Switched Nd: YAG Laser to a Fractionated Laser |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fitzpatrick Skin Type I-VI and Wrinkle Class I
- Between the ages of 25-65
- Evidence of bilateral dyschromia
Key exclusion criteria (24 listed)
- Pregnant, lactating, or is planning to become pregnant
- history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
- any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical or systemic therapy
- coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
- any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the 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 |
|---|---|---|
| RevLite laser treatmentElectro-optic Q-Switched Nd: YAG Laser treatment | Procedure or surgery | Laser treatment |
| Fractionated Laser treatment | Procedure or surgery | Laser treatment |
Primary outcome
Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars
Time frame: 3 and 6 months post final 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 Nov 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.
Neil Sadick, MD principal investigator
Sadick Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RevLite laser treatment and Fractionated Laser treatment in people with Photodamage and Irregular Pigmentation, run by ConBio, a Cynosure Company 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 24 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 Nov 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?
Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars (time frame: 3 and 6 months post final 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 Nov 2012.