Pigmentation DisorderPhase 2NCT01085279
Fractional Laser as Treatment Option for Various Pigment Disorders (Fractional-3)
A Phase 2 study testing Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) and Modified Kligman's formula (Triple topical therapy) in people with Pigmentation Disorder, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pigmentation Disorder
- What is being tested?
- Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) and Modified Kligman's formula (Triple topical therapy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to Feb 2010
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Melasma
- Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
- Age at least 18 years
- Subject is willing and able to give written informed consent
Who cannot join
- use of bleaching creams during the past six weeks
- history of keloid
- active eczema
- suspected hypersensitivity to lidocaine or triple therapy
- use of isotretinoin in the past six months
- high exposure of the lesion to sunlight or UV light (UVA or UVB).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Institute for Pigment disorders
Amsterdam, 1105 AZ
About this study
Official title: Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study
The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.
- Conditions
- Pigmentation Disorder
- Being tested
- Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser), Modified Kligman's formula (Triple topical therapy)
- Keywords
- fractional laser, melasma, topical bleaching
- Medical subject headings
- Pigmentation Disorders, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)Device
Also called Fraxel re:store, Solta Medical Inc., Hayward, CA
1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5
Modified Kligman's formula (Triple topical therapy)Drug
Also called modified Kligman formula
Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| Non-ablative fractional laser | Experimental | In each patient, one side of the face was treated with non-ablative fractional laser in four-five sessions.
Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy. Receives: Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) |
| Triple topical therapy | Active comparator | In each patient, one side of the face was treated with triple topical therapy (Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1%) during 15 weeks.
Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy. Receives: Drug: Modified Kligman's formula (Triple topical therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's global assessment
Improvement of hyperpigmentation was assessed by an independent blinded dermatologist. The results were scored on a scale from zero to six (0: total clearance (100% improvement), 1: almost total clearance (90-99% improvement), 2: distinct clearance (75-89% improvement) 3: moderate clearance (50-74% improvement) 4: mild clearance (25-49% improvement) 5: no change, 6: worsening of hyperpigmentation).
Measured: T0, 3 weeks, and 3 and 6 months follow-up
Secondary outcomes (4)
L-value
Improvement of hyperpigmentation was assessed by color measurement through reflectance spectroscopy (Microflash 200 d, Datacolor International, Lawrenceville, GA). This instrument, with an aperture of 4 mm, determines color by measuring the intensity of reflected light of particular wavelengths. In this study, the obtained L value, indicating the lightness of the measured area of skin, was used.
Measured: T0, 3 weeks and 3 and 6 months follow-up
Melanin index
Melanin index was measured using a spectrometer (Derma-Spectrometer, Cortex Technology ApS, Hadsund, Denmark) in order to assess changes in the amount of dermal and epidermal melanin.
Measured: T0, 3 weeks and 3, and 6 months follow-up
Patient's global assessment
Patients were asked to score the improvement of hyperpigmentation on a visual analogue scale (VAS) from 0 to 10 (Patient's Global Assessment, PGA) at all follow-up moments.
Measured: 3 weeks, 3 and 6 months follow-up
Patient's satisfaction
Patient's satisfaction was scored on a visual analogue scale (VAS) from 0 to 10.
Measured: 3 weeks, 3 and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentation DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Institute for Pigment Disorders
- Sponsor type
- University, hospital or other
- Investigators
- Albert Wolkerstorfer, MD PhD, Principal investigator, Netherlands Institute for Pigment Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085279
- Sponsor's protocol ID
- fractional-3
- Status last verified
- Mar 2010
- First submitted
- 10 Mar 2010
- Last updated
- 11 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-ablative 1,550 nm Fractional Laser Therapy Versus Triple Topical Therapy for the Treatment of Melasma: a Randomized Controlled Split-face Study
- ClinicalTrials.gov ID
- NCT01085279
- Acronym / sponsor ID
- fractional-3
- Conditions
- Pigmentation Disorder
- Keywords
- fractional laser, melasma, topical bleaching
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Netherlands Institute for Pigment DisordersUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Mar 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.
The purpose of this study is to determine whether the use of non-ablative fractional laser is safe and effective in the treatment of melasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-ablative fractional laser | Experimental | Device: Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)In each patient, one side of the face was treated with non-ablative fractional laser in four-five sessions. Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy. |
| Triple topical therapy | Active comparator | Drug: Modified Kligman's formula (Triple topical therapy)In each patient, one side of the face was treated with triple topical therapy (Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1%) during 15 weeks. Note: this study had a split-face design. In each patient, each side of the face was randomized to receive either non-ablative fractional laser therapy or triple topical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Melasma
- Subjects attending the outpatient department of the Netherlands Institute for Pigment Disorders
- Age at least 18 years
- Subject is willing and able to give written informed consent
Key exclusion criteria (6 listed)
- use of bleaching creams during the past six weeks
- history of keloid
- active eczema
- suspected hypersensitivity to lidocaine or triple therapy
- use of isotretinoin in the past six months
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 |
|---|---|---|
| Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)Also: Fraxel re:store, Solta Medical Inc., Hayward, CA1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5 | Device | Non-ablative fractional laser |
| Modified Kligman's formula (Triple topical therapy)Also: modified Kligman formulaHydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks | Drug | Triple topical therapy |
Primary outcome
Physician's global assessment
Time frame: T0, 3 weeks, and 3 and 6 months follow-up
Improvement of hyperpigmentation was assessed by an independent blinded dermatologist. The results were scored on a scale from zero to six (0: total clearance (100% improvement), 1: almost total clearance (90-99% improvement), 2: distinct clearance (75-89% improvement) 3: moderate clearance (50-74% improvement) 4: mild clearance (25-49% improvement) 5: no change, 6: worsening of hyperpigmentation).
4 secondary outcomes
L-value
Time frame: T0, 3 weeks and 3 and 6 months follow-up
Melanin index
Time frame: T0, 3 weeks and 3, and 6 months follow-up
Patient's global assessment
Time frame: 3 weeks, 3 and 6 months follow-up
Patient's satisfaction
Time frame: 3 weeks, 3 and 6 months follow-up
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 11 Mar 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.
Albert Wolkerstorfer, MD PhD principal investigator
Netherlands Institute for Pigment Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser) and Modified Kligman's formula (Triple topical therapy) in people with Pigmentation Disorder, run by Netherlands Institute for Pigment Disorders at 1 site in Netherlands.
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 4 inclusion and 6 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 11 Mar 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 Netherlands. 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 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?
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?
Physician's global assessment (time frame: T0, 3 weeks, and 3 and 6 months follow-up). 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 11 Mar 2010.