A Prospective Multi-Center Study Using Laser for the Treatment of Melasma and Lentigines in Asian Skin
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|ClinicalTrials.gov Identifier: NCT02385994|
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melasma Lentigines||Device: enLighten Laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Multi-Center Study of a Novel Dual-Wavelength, Dual-Pulse Duration Laser for the Treatment of Melasma and Lentigines in Asian Skin|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: enLighten Laser Treatment
Melasma, Cohort I or Lentigines, Cohort II will be treated with dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser.
Device: enLighten Laser
enLighten Laser treatment with dual-pulse width and dual-wavelength
No Intervention: Control
Melasma subjects randomized to non-treatment will receive no treatments.
- Investigator Assessment measured by 5-point improvement scale [ Time Frame: 12 weeks ]Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
- Subject Assessment measured by 5-point improvement scale [ Time Frame: 12 weeks ]Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale.
- Melasma Subject's MASI Improvement [ Time Frame: 12 weeks ]Change in mean Melasma Area and Severity Index (MASI) value at 3 months post-final treatment as compared to baseline
- Relative Melanin Index [ Time Frame: 12 weeks ]Change in mean relative Melanin Index (MI) value at 3 months post-final treatment as compared to baseline as assessed by mexameter measurements
- Pain and Adverse Events [ Time Frame: Day 1 ]Incidence and severity of adverse device effects during the study period, including subject pain level during laser treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385994
|Hong Kong Dermatology and Laser Centre|
|Hong Kong, China|
|Aoyama Institute of Women's Medicine|
|Principal Investigator:||Henry Hin-Lee Chan, M.D., Ph.D||Hong Kong Dermatology and Laser Centre|
|Principal Investigator:||Kei Negishi, M.D., Ph.D||Tokyo Women's Medical University|