Skin AgingPhase 4NCT00994474
Comparison of Outcome Parameters in Laser Rhytide Treatment
A Phase 4 study testing Fractional carbon dioxide laser treatment and Fractional Er:YAG laser treatment in people with Skin Aging, run by Laserklinik Karlsruhe at 1 site in Germany.
Trial summary
We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial… Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Fractional carbon dioxide laser treatment and Fractional Er:YAG laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Mar 2009
- Phase
- Phase 4
- 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)
Who cannot join
- unrealistic expectations
- inability to meet follow-up criteria
- Fitzpatrick skin phototype >III
- coagulation disorders or anti-coagulant treatment
- allergy to lidocaine or tetracaine
- oral isotretinoin within the last 6 months
Show all 12Show fewer
- any active skin disease within the treatment areas (e.g., psoriasis, cancer, or autoimmune disease)
- synthetic implants in the treatment area
- facial cosmetic procedures affecting the treatment area within the last 6 months
- photosensitizing medications (e.g., tetracycline, gold)
- history of keloid formation
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides
We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.
- Conditions
- Skin Aging
- Being tested
- Fractional carbon dioxide laser treatment, Fractional Er:YAG laser treatment
- Keywords
- Laser surgery, Profilometry, Fitzpatrick wrinkle score, Patient Benefit Index, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional carbon dioxide laser treatmentProcedure or surgery
With the CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA), patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %. We employed 'pin-point bleeding' and serosanguinous exudate as a clinical end point. The pulse duration was 10 msec.
Fractional Er:YAG laser treatmentProcedure or surgery
The Er:YAG laser (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany) was used in 4 passes with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses); the pulse duration was 400 μsec.
| Study group | Role | What they receive |
|---|---|---|
| Fractional carbon dioxide laser treatment | Active comparator | Not described Receives: Procedure: Fractional carbon dioxide laser treatment |
| Fractional Er:YAG laser treatment | Active comparator | Not described Receives: Procedure: Fractional Er:YAG laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative measurement of wrinkle depth
Measured: Before and after treatment (3 months)
Fitzpatrick wrinkle score
Measured: Before and after treatment (3 months)
Secondary outcomes (2)
Patient benefit index (PBI)
Measured: Before and after treatment (3 months)
Patient satisfaction
Measured: 1, 3, 6 days and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laserklinik Karlsruhe
- Sponsor type
- University, hospital or other
- Investigators
- Syrus Karsai, MD, Principal investigator, Laserklinik Karlsruhe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994474
- Sponsor's protocol ID
- LK_06_2009
- Status last verified
- Oct 2009
- First submitted
- 13 Oct 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcome Parameters, the Patient Benefit Index (PBI) and Patient Satisfaction After Ablative Fractional Laser Treatment of Peri-orbital Rhytides
- ClinicalTrials.gov ID
- NCT00994474
- Acronym / sponsor ID
- LK_06_2009
- Conditions
- Skin Aging
- Keywords
- Laser surgery, Profilometry, Fitzpatrick wrinkle score, Patient Benefit Index, Patient satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Laserklinik KarlsruheUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Oct 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.
We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional carbon dioxide laser treatment | Active comparator | Procedure: Fractional carbon dioxide laser treatment |
| Fractional Er:YAG laser treatment | Active comparator | Procedure: Fractional Er:YAG laser treatment |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mild to moderate peri-orbital rhytides ('crow's feet') at rest (Class II according to Fitzpatrick)
Key exclusion criteria (12 listed)
- unrealistic expectations
- inability to meet follow-up criteria
- Fitzpatrick skin phototype >III
- coagulation disorders or anti-coagulant treatment
- allergy to lidocaine or tetracaine
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 |
|---|---|---|
| Fractional carbon dioxide laser treatmentWith the CO2 laser (Fraxel Re:pair, Solta Medical Inc., Hayward, CA), patients received two passes at 15 mJ (1st pass) and 20 mJ (2nd pass), respectively, with a total density of 20 %. We employed 'pin-point bleeding' and serosanguinous exudate as a clinical end point. The pulse duration was 10 msec. | Procedure or surgery | Fractional carbon dioxide laser treatment |
| Fractional Er:YAG laser treatmentThe Er:YAG laser (MCL 30 Dermablate, Asclepion Laser Technologies GmbH, Jena, Germany) was used in 4 passes with a total fluence of 60 J/cm² and pulse stacking (6 stacked pulses); the pulse duration was 400 μsec. | Procedure or surgery | Fractional Er:YAG laser treatment |
Primary outcome
Quantitative measurement of wrinkle depth
Time frame: Before and after treatment (3 months)
Fitzpatrick wrinkle score
Time frame: Before and after treatment (3 months)
2 secondary outcomes
Patient benefit index (PBI)
Time frame: Before and after treatment (3 months)
Patient satisfaction
Time frame: 1, 3, 6 days and 3 months after 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 14 Oct 2009.
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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.
Syrus Karsai, MD principal investigator
Laserklinik Karlsruhe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fractional carbon dioxide laser treatment and Fractional Er:YAG laser treatment in people with Skin Aging, run by Laserklinik Karlsruhe at 1 site in Germany.
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 1 inclusion and 12 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 14 Oct 2009. 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 Germany. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantitative measurement of wrinkle depth (time frame: Before and after treatment (3 months)). The study lists 2 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 14 Oct 2009.