Pigmentation DisorderPhase 2fractional-2NCT01083498
Fractional Laser as Treatment Option for Various Pigment Disorders
A Phase 2 study testing Ablative fractional laser therapy in people with Pigmentation Disorder, run by Netherlands Institute for Pigment Disorders.
Trial summary
The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus. 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?
- Ablative fractional laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jan 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
- Becker nevus
- 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).
About this study
Official title: Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study
The purpose of this study is to determine whether the use of ablative fractional laser is effective in the treatment of Becker's nevus.
Read the detailed description
Becker's nevus (BN) is an uncommon pigment disorder of the epidermis characterized by increased pigmentation, a slightly elevated, verrucous surface of the affected skin and sometimes hyperpigmentation. No effective treatment is available. Several laser modalities have been applied in the treatment of Becker's nevus in uncontrolled studies with varying results. Recently, fractional laser therapy was suggested as treatment option for Becker's nevus. In fractional laser therapy, microscopic columns of skin are coagulated or ablated, leaving the surrounding tissue intact, which enhances healing of the treated skin. In this study, the efficacy and safety of ablative fractional laser therapy was assessed in the treatment of Becker's nevus.
- Conditions
- Pigmentation Disorder
- Being tested
- Ablative fractional laser therapy
- Keywords
- Becker's nevus, ablative fractional laser therapy, randomized controlled trial, split-lesion design
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative fractional laser therapyDevice
Also called Fraxel re:pair, Solta Medical Inc., Hayward, CA
10,600 nm ablative fractional laser Irradiance: 10 mJ/microbeam. Coverage: 35-45%. Number of treatment sessions: 3
| Study group | Role | What they receive |
|---|---|---|
| Ablative fractional laser | Experimental | In each patient, a square test region of 5-10 cm2 was treated with ablative fractional laser in three sessions in combination with intermittent topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream) to prevent laser-induced postinflammatory hyperpigmentation.
Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment. Receives: Device: Ablative fractional laser therapy |
| Control | No intervention | In each patient, a square test region of 5-10 cm2 was treated with topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream)alone (to allow comparison of the regions). Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment. |
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 and 6 months follow-up
Secondary outcomes (5)
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, reflecting the lightness of the measured area of skin, was used.
Measured: T0, 3 and six 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 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 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 and 6 months follow-up
Histopathologic assessment
In order to evaluate for microscopic and ultrastructural treatment induced changes, 2 mm punch biopsies were taken from all patients at three months follow-up. Biopsies were taken from the optical centre of both treated and control site. All biopsy specimens were split for processing for light microscopy. .... was assessed by an independent blinded pathologist.
Measured: 3 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 posted9 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Institute for Pigment Disorders
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083498
- Sponsor's protocol ID
- fractional-2
- Acronym
- fractional-2
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablative Fractional Laser Therapy as Treatment for Becker's Nevus; a Pilot Study
- ClinicalTrials.gov ID
- NCT01083498
- Acronym / sponsor ID
- fractional-2 / fractional-2
- Conditions
- Pigmentation Disorder
- Keywords
- Becker's nevus, ablative fractional laser therapy, randomized controlled trial, split-lesion design
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Netherlands Institute for Pigment DisordersUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 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 ablative fractional laser is effective in the treatment of Becker's nevus.
Detailed description
Becker's nevus (BN) is an uncommon pigment disorder of the epidermis characterized by increased pigmentation, a slightly elevated, verrucous surface of the affected skin and sometimes hyperpigmentation. No effective treatment is available. Several laser modalities have been applied in the treatment of Becker's nevus in uncontrolled studies with varying results. Recently, fractional laser therapy was suggested as treatment option for Becker's nevus. In fractional laser therapy, microscopic columns of skin are coagulated or ablated, leaving the surrounding tissue intact, which enhances healing of the treated skin. In this study, the efficacy and safety of ablative fractional laser therapy was assessed in the treatment of Becker's nevus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablative fractional laser | Experimental | Device: Ablative fractional laser therapyIn each patient, a square test region of 5-10 cm2 was treated with ablative fractional laser in three sessions in combination with intermittent topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream) to prevent laser-induced postinflammatory hyperpigmentation. Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment. |
| Control | No intervention | –In each patient, a square test region of 5-10 cm2 was treated with topical bleaching with triple topical therapy (hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% cream)alone (to allow comparison of the regions). Note: this study had a split-lesion design. In each patient, two test regions were randomized to receive either ablative fractional laser therapy or no treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Becker nevus
- 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 |
|---|---|---|
| Ablative fractional laser therapyAlso: Fraxel re:pair, Solta Medical Inc., Hayward, CA10,600 nm ablative fractional laser Irradiance: 10 mJ/microbeam. Coverage: 35-45%. Number of treatment sessions: 3 | Device | Ablative fractional laser |
Primary outcome
Physician's global assessment
Time frame: T0, 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).
5 secondary outcomes
L-value
Time frame: T0, 3 and six months follow-up
Melanin index
Time frame: T0, 3 and 6 months follow-up
Patient's global assessment
Time frame: 3 and 6 months follow-up
Patient's satisfaction
Time frame: 3 and 6 months follow-up
Histopathologic assessment
Time frame: 3 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 9 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ablative fractional laser therapy in people with Pigmentation Disorder, run by Netherlands Institute for Pigment Disorders.
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 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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 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 9 Mar 2010.