Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01850186
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2013-04-23
Brief Title:
Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Comparative Study of Dual Yellow Laser Versus Stabilized Kilnman Preparation in the Treatment of Melasma
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
1 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
2 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
3 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
4 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
5 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 sessionPatients continue the applications of cream on the contralateral side
6 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
7 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
8 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
9 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
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
1 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
2 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
3 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
4 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
5 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 sessionPatients continue the applications of cream on the contralateral side
6 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
7 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
8 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
9 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None