MelasmaNCT01850186
Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma
A study testing Dual yellow Laser and Stabilized kilnman trio in people with Melasma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Recent data highlight the role of vascularity in melasma and a recent study showed the interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melasma
- What is being tested?
- Dual yellow Laser and Stabilized kilnman trio
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Sep 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, ≤75 years.
- Clinical diagnosis of melasma
- Fitzpatrick phototype 1 to 4.
- Effective contraception will be maintained for the duration of the study.
- Affiliation to the Social Security
- Informed consent signed by the patient
Who cannot join
- Pregnant or breastfeeding women; effective contraception will be maintained for the duration of the study.
- Fitzpatrick phototype ≥ 5
- Intolerance or allergy to compounds of
- Exposure to UV or concomitant exposure to the sun without 50+ protective shield.
- Concomitant topical treatments may be effective on melasma (topical corticosteroids, topical retinoids)
Trial locations and contacts
1 site in 1 country.
About this study
Recent data highlight the role of vascularity in melasma and a recent study showed the interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser can target both the vascular and pigmented components of melasma. A preliminary study has shown its efficacy and excellent tolerability in the treatment of melasma. This study requires however to be confirmed by a comparative study versus reference treatment.
Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in an intra-patient study.
Read more
Secondary objectives
- To study the frequency of PPI.
- Compare the rate and extent of recurrence 6 months after completion of treatment.
- To study the occurrence of possible adverse effects.
- Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end of treatment).
- To study patient satisfaction on the effectiveness and tolerability of the study treatments.
Methods Monocentric prospective interventional randomized split face comparative study between experimental treatment versus reference treatment.
Intervention
- Visit Selection Patients will be selected from those presenting to the consultation of the department of dermatology at University Hospital of Nice. Participation will be offered to patients corresponding to the selection criteria of the study.
- Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin the study. This will ensure that patients signed informed consent. An initial clinical evaluation of melasma with calculation of MASI score and standardized photographs (see chapter 'assessment') will be made. An examination by confocal microscopy in vivo will be realized. All patients will receive treatment by stabilized kilnman trio for four weeks. In the week prior to Visit 1, the side of the face to receive the laser treatment will be determined by randomisation.
- Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The contralateral side will receive its first laser session. Given the results of analysis by intention to treat, the occurrence of serious side effects will result in discontinuation of treatment but monitoring will continue with the assessments.
- Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The laser side will receive its second session. Patients continue the applications of cream on the contralateral side.
- Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The laser side will receive its third session.Patients continue the applications of cream on the contralateral side.
- Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The laser side will receive its fourth and final session. Patients continue the applications of cream on the contralateral side during 4 weeks.
- Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
- Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
- Visit V7 (final week 36):
Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized. The evaluation of safety and patient satisfaction will be performed using a visual analog scale.
The primary endpoint will be the MASI score, score approved for assessment of melasma treatments.
- Conditions
- Melasma
- Being tested
- Dual yellow Laser, Stabilized kilnman trio
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual yellow LaserDevice
Patients will receive treatment by stabilized kilnman trio for four weeks (one application per day). Patient will receive 4 treatments by Dual yellow Laser on the hemi-face (side determinated by randomisation, split body study) at weeks 4, 6, 9 and 12.
Stabilized kilnman trioDrug
The stabilized kilnman trio will be prescribed for one month at inclusion (all over the face, one application per day), and on the half of the face not treated by laser at weeks 4, 8 and 12 (one application per day).
| Study group | Role | What they receive |
|---|---|---|
| Dual yellow Laser | Experimental | Patients will receive treatment by stabilized kilnman trio for four weeks (one application per day). Patient will receive 4 treatments by Dual yellow Laser on the hemi-face (side determinated by randomisation, split body study) at weeks 4, 6, 9 and 12. Receives: Device: Dual yellow Laser |
| Stabilized kilnman trio | Placebo comparator | Patients will receive treatment by stabilized kilnman trio for four weeks on all the face (one application per day). At the beginning of week 5, Patient will receive stabilized kilnman trio on the hemi-face during three months (side not treated by dual yellow laser, split body study). The stabilized kilnman trio will be prescribed for one month at inclusion (applied all over the face), and on the half of the face not treated by laser at weeks 4, 8 and 12. Receives: Drug: Stabilized kilnman trio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring systems in dermatology
The primary endpoint will be the Scoring systems in dermatology (MASI score), score approved for assessment of melasma treatments compared between inclusion and after 6 month of treatment.
A blind treatment evaluation of direct light, UV and polarized photographs (VISIA, cornfield ©) between inclusion and after 6 month of treatment will be performed by an independent observer (dermatologist).
Measured: 36 weeks
Secondary outcomes (1)
Tolerance and sever adverse event
- Effectiveness and tolerance of the patient will be studied using visual analog scales (VAS) graded from 0 to 10.
- Side effects: frequency, severity and time of occurrence of side effects will be reported for each treatment. Side effects are classified into grades according to WHO criteria.
- The occurrence of PPI will be sought during the clinical examination at each visit.
- The concept of relapse will be determined using the MASI score. Will be considered as relapsed patients with MASI score at 6 months returned to baseline or above pretreatment.
- An examination by confocal microscopy in vivo will evaluate with precision the histological evolution of the lesions treated between inclusion and weeks 18, 24 and 36 (end of study).
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelasmaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PASSERON Thierry, PU-PH, Principal investigator, CHU de Nice - Hôpital de l'Archet - Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850186
- Sponsor's protocol ID
- 11-PP-15
- Status last verified
- Feb 2015
- First submitted
- 23 Apr 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hammami Ghorbel H, Boukari F, Fontas E, Montaudie H, Bahadoran P, Lacour JP, Passeron T. Copper Bromide Laser vs Triple-Combination Cream for the Treatment of Melasma: A Randomized Clinical Trial. JAMA Dermatol. 2015 Jul;151(7):791-2. doi: 10.1001/jamadermatol.2014.5580. No abstract available.
PubMed 25715311
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT01850186
- Acronym / sponsor ID
- 11-PP-15
- Conditions
- Melasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 May 2013 (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.
Recent data highlight the role of vascularity in melasma and a recent study showed the interest to target this vascular component by pulsed dye laser. The Dual Yellow laser is a copper bromide laser emitting dual wavelength (green 511nm and yellow 578 nm). This laser can target both the vascular and pigmented components of melasma. A preliminary study has shown its efficacy and excellent tolerability in the treatment of melasma. This study requires however to be confirmed by a comparative study versus reference treatment.
Main objective To compare the efficacy on melasma at 6 month post treatment of a Dual Yellow Laser preceded by 1 month of kilnman trio and the kilnman trio monotherapy for 3 months in an intra-patient study.
Secondary objectives
- To study the frequency of PPI.
- Compare the rate and extent of recurrence 6 months after completion of treatment.
- To study the occurrence of possible adverse effects.
- Compare the effectiveness of Dual Yellow laser to kilnman trio monotherapy at S12 (end of treatment).
- To study patient satisfaction on the effectiveness and tolerability of the study treatments.
Methods Monocentric prospective interventional randomized split face comparative study between experimental treatment versus reference treatment.
Intervention
- Visit Selection Patients will be selected from those presenting to the consultation of the department of dermatology at University Hospital of Nice. Participation will be offered to patients corresponding to the selection criteria of the study.
- Visit V0: Inclusion and early treatment After a minimum of 15 days, patients will begin the study. This will ensure that patients signed informed consent. An initial clinical evaluation of melasma with calculation of MASI score and standardized photographs (see chapter 'assessment') will be made. An examination by confocal microscopy in vivo will be realized. All patients will receive treatment by stabilized kilnman trio for four weeks. In the week prior to Visit 1, the side of the face to receive the laser treatment will be determined by randomisation.
- Visit V1: (Week 4) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The next trio will be treated with depigmenting kilnman trio for another 8 weeks. The contralateral side will receive its first laser session. Given the results of analysis by intention to treat, the occurrence of serious side effects will result in discontinuation of treatment but monitoring will continue with the assessments.
- Visit V2: (week 6) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The laser side will receive its second session. Patients continue the applications of cream on the contralateral side.
- Visit V3 (week 9) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The laser side will receive its third session.Patients continue the applications of cream on the contralateral side.
- Visit V4 (week 12) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. The laser side will receive its fourth and final session. Patients continue the applications of cream on the contralateral side during 4 weeks.
- Visit V5: (week 18) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
- Visit V6: (week 24) Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized.
- Visit V7 (final week 36):
Clinical evaluation of melasma with calculation of MASI score and photographs will be made. Possible side effects (including PPI) will be noted. An assessment by in vivo confocal laser will be realized. The evaluation of safety and patient satisfaction will be performed using a visual analog scale.
The primary endpoint will be the MASI score, score approved for assessment of melasma treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual yellow Laser | Experimental | Device: Dual yellow LaserPatients will receive treatment by stabilized kilnman trio for four weeks (one application per day). Patient will receive 4 treatments by Dual yellow Laser on the hemi-face (side determinated by randomisation, split body study) at weeks 4, 6, 9 and 12. |
| Stabilized kilnman trio | Placebo comparator | Drug: Stabilized kilnman trioPatients will receive treatment by stabilized kilnman trio for four weeks on all the face (one application per day). At the beginning of week 5, Patient will receive stabilized kilnman trio on the hemi-face during three months (side not treated by dual yellow laser, split body study). The stabilized kilnman trio will be prescribed for one month at inclusion (applied all over the face), and on the half of the face not treated by laser at weeks 4, 8 and 12. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years, ≤75 years.
- Clinical diagnosis of melasma
- Fitzpatrick phototype 1 to 4.
- Effective contraception will be maintained for the duration of the study.
- Affiliation to the Social Security
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women; effective contraception will be maintained for the duration of the study.
- Fitzpatrick phototype ≥ 5
- Intolerance or allergy to compounds of
- Exposure to UV or concomitant exposure to the sun without 50+ protective shield.
- Concomitant topical treatments may be effective on melasma (topical corticosteroids, topical retinoids)
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 |
|---|---|---|
| Dual yellow LaserPatients will receive treatment by stabilized kilnman trio for four weeks (one application per day). Patient will receive 4 treatments by Dual yellow Laser on the hemi-face (side determinated by randomisation, split body study) at weeks 4, 6, 9 and 12. | Device | Dual yellow Laser |
| Stabilized kilnman trioThe stabilized kilnman trio will be prescribed for one month at inclusion (all over the face, one application per day), and on the half of the face not treated by laser at weeks 4, 8 and 12 (one application per day). | Drug | Stabilized kilnman trio |
Primary outcome
Scoring systems in dermatology
Time frame: 36 weeks
The primary endpoint will be the Scoring systems in dermatology (MASI score), score approved for assessment of melasma treatments compared between inclusion and after 6 month of treatment. A blind treatment evaluation of direct light, UV and polarized photographs (VISIA, cornfield ©) between inclusion and after 6 month of treatment will be performed by an independent observer (dermatologist).
1 secondary outcome
Tolerance and sever adverse event
Time frame: 36 weeks
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 16 Feb 2015.
- Derived from this study: PubMed 25715311Hammami Ghorbel H, Boukari F, Fontas E, Montaudie H, Bahadoran P, Lacour JP, Passeron T. Copper Bromide Laser vs Triple-Combination Cream for the Treatment of Melasma: A Randomized Clinical Trial. JAMA Dermatol. 2015 Jul;151(7):791-2. doi: 10.1001/jamadermatol.2014.5580. No abstract available.
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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.
PASSERON Thierry, PU-PH principal investigator
CHU de Nice - Hôpital de l'Archet - Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual yellow Laser and Stabilized kilnman trio in people with Melasma, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 5 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 16 Feb 2015. 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 France. 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. Some participants in this study may receive a placebo. 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?
Scoring systems in dermatology (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850186, which also lists 1 linked publication.
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 16 Feb 2015.