Skin AgingNCT00766376
Safety and Efficacy Evaluation of Erbium Treatment
A study testing Erbium laser in people with Skin Aging, run by Palomar Medical Technologies, Inc. at 5 sites in United States.
Trial summary
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Aging
- What is being tested?
- Erbium laser
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2007to Jul 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male and female Adults (18 years or older).
- Subjects who can read, understand, and sign the Informed Consent Form.
- Subjects willing and able to comply with all study requirements.
Who cannot join
- Subjects with active localized or systemic infections.
- Immunocompromised subjects.
- Subjects with coagulation disorder.
- History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
- Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
- In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
Show all 10Show fewer
- Use of Accutane® within the past 6 months.
- Subjects with a history of radiation therapy to the treatment area.
- Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
- Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Palomar Medical Technologies, Inc.
Burlington, Massachusetts, 01803
Brooke Seckel, MD
Concord, Massachusetts, 01742
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Skin & Laser Surgery Center
Nashua, New Hampshire, 03060
Scripps Clinic Laser & Cosmetic Dermatology
San Diego, California, 92130
About this study
Official title: Safety and Efficacy Evaluation of Fractional Erbium Treatment
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
Read the detailed description
The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures.
Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.
- Conditions
- Skin Aging
- Being tested
- Erbium laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium laserDevice
Erbium laser treatment. Each subject will undergo up to 6 treatment sessions
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.
To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.
Measured: participants at three months
Secondary outcomes (1)
Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.
To assess reductions in pigmented lesions and dyschromia, blinded evaluators were asked to assess pre-treatment and post-treatment photographs. The blinded evaluators were asked to grade percent improvement for pigmentation using a 0 to 10 scale (0=none and 10=severe) and the following quartile improvement scale: 1=1-24%, 2=25-49%, 3=50-74% and 4=75-100%. The blinded-evaluator scores were tabulated and analyzed in order to assess the effects.
Measured: participants at three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
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 Skin AgingStudies 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
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palomar Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766376
- Sponsor's protocol ID
- ERf-02
- Status last verified
- Jan 2010
- First submitted
- 30 Sep 2008
- Last updated
- 29 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Fractional Erbium Treatment
- ClinicalTrials.gov ID
- NCT00766376
- Acronym / sponsor ID
- ERf-02
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Palomar Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Posted 29 Jan 2010
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 erbium lasers for dermatological cosmetic procedures.
Detailed description
The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures.
Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female Adults (18 years or older).
- Subjects who can read, understand, and sign the Informed Consent Form.
- Subjects willing and able to comply with all study requirements.
Key exclusion criteria (10 listed)
- Subjects with active localized or systemic infections.
- Immunocompromised subjects.
- Subjects with coagulation disorder.
- History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
- Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of 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 |
|---|---|---|
| Erbium laserErbium laser treatment. Each subject will undergo up to 6 treatment sessions | Device | – |
Primary outcome
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.
Time frame: participants at three months
To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.
1 secondary outcome
Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.
Time frame: participants at three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erbium laser in people with Skin Aging, run by Palomar Medical Technologies, Inc. at 5 sites 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 10 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: status not confirmed, as of the sponsor's last update on 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 29 Jan 2010). 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?
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale. (time frame: participants at three months). 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 Jan 2010.