Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of melasma and lentigines on the face in Asian skin.
This is a multi-center prospective, 2 cohort study in 80 male or female subjects of Asian-descent, who desire laser treatment for moderate to severe melasma (all types) or lentigines (all types) located on the face. Forty subjects will be enrolled in cohort 1 and randomized to either treatment or control arm. Forty subjects will be enrolled for treatment of facial lentigines in cohort 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enLighten Laser Treatment | Experimental | Melasma, Cohort I or Lentigines, Cohort II will be treated with dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser. |
|
| Control | No Intervention | Melasma subjects randomized to non-treatment will receive no treatments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enLighten Laser | Device | enLighten Laser treatment with dual-pulse width and dual-wavelength |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Assessment measured by 5-point improvement scale | Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Assessment measured by 5-point improvement scale | Degree of improvement in melasma or lentigines at 3 months post-final treatment measured by 5-point improvement scale. | 12 weeks |
| Melasma Subject's MASI Improvement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Dermatology and Laser Centre | Hong Kong | China | ||||
| Aoyama Institute of Women's Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 6, 2023 | |
| Reset | Dec 13, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 6, 2023 | Dec 13, 2023 |
| ID | Term |
|---|---|
| D008548 | Melanosis |
| D007911 | Lentigo |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in mean Melasma Area and Severity Index (MASI) value at 3 months post-final treatment as compared to baseline
| 12 weeks |
| Relative Melanin Index | Change in mean relative Melanin Index (MI) value at 3 months post-final treatment as compared to baseline as assessed by mexameter measurements | 12 weeks |
| Pain and Adverse Events | Incidence and severity of adverse device effects during the study period, including subject pain level during laser treatment | Day 1 |
| Tokyo |
| Japan |