MelasmaNCT01245881
Fractional Photothermolysis for Treating Melasma
A study testing Non-ablative fractional photothermolysis laser and broad-spectrum sunblock (SPF 50+) in people with Melasma, run by Laserklinik Karlsruhe at 1 site in Germany.
Trial summary
In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melasma
- What is being tested?
- Non-ablative fractional photothermolysis laser and broad-spectrum sunblock (SPF 50+)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2008to Dec 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (female/male) with clinical evidence of melasma;
- Fitzpatrick skin phototype I-III;
- Ability and willingness to comply with the requirements of the protocol.
Who cannot join
- Pregnancy or nursing;
- Inability to avoid sun exposure for occupational reasons (e.g., gardeners);
- Known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic;
- Use of topical retinoids within 3 months prior to study enrolment;
- Use of topical hydroquinone within 6 months prior to study enrolment;
- Use of topical corticosteroids within 1 month prior to study enrolment;
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- Use of topical cosmetic depigmenting agents within 2 weeks prior to study enrolment;
- Laser surgery procedures within the treatment region during the last 12 weeks prior to enrolment;
- Coagulation disorders or anticoagulant treatment;
- Photo-sensitizing medication (e.g., tetracyclines, gold).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma
In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. While some beneficial effects have been attributed to non-ablative FP in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and safety of FP in the treatment of melasma as compared to the lone application of a sun-blocking lotion (SPF >50).
- Conditions
- Melasma
- Being tested
- Non-ablative fractional photothermolysis laser, broad-spectrum sunblock (SPF 50+)
- Keywords
- controlled trial, fractional photothermolysis, laser surgery, melasma, pigment disorder
- Medical subject headings
- Melanosis, Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-ablative fractional photothermolysis laserDevice
- Wavelength: 1,550 nm;
- Energy: 15 mJ/MTZ;
- Total coverage: 20%;
- Total density: 1,048 MTZs/cm2;
- Density per pass: 131 MTZ/cm2;
- Number of passes: 8.
broad-spectrum sunblock (SPF 50+)Other
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Broad-spectrum UV block plus non-ablative 1,550-nm fractional treatment Receives: Device: Non-ablative fractional photothermolysis laser |
| Control group | Active comparator | Not described Receives: Other: broad-spectrum sunblock (SPF 50+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment
Measured: Pre-treatment and at final follow-up (12 weeks after last treatment session)
Secondary outcomes (3)
Subjective assessment of treatment outcome (by patients)
Measured: Pre-treatment and at final follow-up
Patient satisfaction
Measured: Pre-treatment and at final follow-up
Side effects
Measured: At each follow-up visit (week 3, 6, 9, 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelasmaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laserklinik Karlsruhe
- Sponsor type
- University, hospital or other
- Collaborators
- Laser and Skin Centre Potsdam, Potsdam, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245881
- Sponsor's protocol ID
- LK-13-2010
- Status last verified
- Nov 2010
- First submitted
- 19 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of Fractional Photothermolysis in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT01245881
- Acronym / sponsor ID
- LK-13-2010
- Conditions
- Melasma
- Keywords
- controlled trial, fractional photothermolysis, laser surgery, melasma, pigment disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Laserklinik KarlsruheUniversity, hospital or other
- Collaborators
- Laser and Skin Centre Potsdam, Potsdam, Germany
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Nov 2010 (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.
In several observational studies, non-ablative fractional photothermolysis (FP) has been reported to bridge the gap between efficacy and tolerability in the treatment of melasma. While some beneficial effects have been attributed to non-ablative FP in treating melasma, methodological constraints (e.g., a limited number of patients; no control group assignment) impair efficacy assessment; currently published results neither allow researchers and clinicians to draw valid conclusions nor warrant recommendations for therapy. In particular, bias resulting from poorly designed trials may mislead clinicians into making a wrong decision and generate not only unnecessary treatment (i.e., costs), but also a risk of side effects for patients. Therefore, the purpose of this trial was to clarify the efficacy and safety of FP in the treatment of melasma as compared to the lone application of a sun-blocking lotion (SPF >50).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Non-ablative fractional photothermolysis laserBroad-spectrum UV block plus non-ablative 1,550-nm fractional treatment |
| Control group | Active comparator | Other: broad-spectrum sunblock (SPF 50+) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (female/male) with clinical evidence of melasma;
- Fitzpatrick skin phototype I-III;
- Ability and willingness to comply with the requirements of the protocol.
Key exclusion criteria (10 listed)
- Pregnancy or nursing;
- Inability to avoid sun exposure for occupational reasons (e.g., gardeners);
- Known history or clinically relevant allergy to components of the sunscreen or topical anaesthetic;
- Use of topical retinoids within 3 months prior to study enrolment;
- Use of topical hydroquinone within 6 months prior to study enrolment;
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 |
|---|---|---|
| Non-ablative fractional photothermolysis laser* Wavelength: 1,550 nm; * Energy: 15 mJ/MTZ; * Total coverage: 20%; * Total density: 1,048 MTZs/cm2; * Density per pass: 131 MTZ/cm2; * Number of passes: 8. | Device | Treatment group |
| broad-spectrum sunblock (SPF 50+) | Other | Control group |
Primary outcome
Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment
Time frame: Pre-treatment and at final follow-up (12 weeks after last treatment session)
3 secondary outcomes
Subjective assessment of treatment outcome (by patients)
Time frame: Pre-treatment and at final follow-up
Patient satisfaction
Time frame: Pre-treatment and at final follow-up
Side effects
Time frame: At each follow-up visit (week 3, 6, 9, 12)
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 23 Nov 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-ablative fractional photothermolysis laser and broad-spectrum sunblock (SPF 50+) in people with Melasma, 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 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: finished, as of the sponsor's last update on 23 Nov 2010. 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.
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?
Change from Baseline in Melasma Area and Severity Index (MASI) at 12 weeks after final treatment (time frame: Pre-treatment and at final follow-up (12 weeks after last treatment session)). 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 23 Nov 2010.