A Prospective Multi-Center Study Using Laser for the Treatment of Melasma and Lentigines in Asian Skin

NCT02385994 | Completed

• 1 other identifier: C-14-EN01
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Melasma; Lentigines

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Subject Assessment measured by 5-point improvement scale

  12 weeks

• Melasma Subject's MASI Improvement

  12 weeks

• Relative Melanin Index

  12 weeks

• Pain and Adverse Events

  Day 1

Study Arms (2)

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.

Device: enLighten Laser

Control

NO INTERVENTION

Melasma subjects randomized to non-treatment will receive no treatments.

Interventions

enLighten Laser DEVICE

enLighten Laser treatment with dual-pulse width and dual-wavelength

enLighten Laser Treatment

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or Male, 20 to 75 years of age (inclusive).
• Fitzpatrick Skin Type III - V.
• Has moderate to severe melasma (any type), OR any type of lentigo/lentigines ≥ 6mm in diameter, and desires laser treatment.
• Willing to refrain from using topical and systemic corticosteroids or retinoids, and topical or systemic prescription skin-lightening medications, except permitted topical steroid use as directed by study doctor.
• Willing to maintain consistent skin care regimen on the treatment area for the duration of the study, including the follow-up period.
• Must be able to read, understand and sign the Informed Consent Form.
• Must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
• Willing to have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treatment area every day for the duration of the study, including the follow-up period.
• Willing to have digital photographs taken of the treatment area.
• Agree not to undergo any other procedure(s) in the treatment area during the study.
• Post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.

You may not qualify if:

• Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser or light-based procedures or surgery.
• Prior injection of collagen, hyaluronic acid filler or any other dermal filler in the target area within 6 months of study participation.
• Has mild melasma OR facial lentigo/lentigines less than 6mm in diameter.
• History of refractory melasma.
• History of allergy to local anesthetics, as applicable.
• History of malignant tumors in the target area.
• Skin abnormalities in the target area, e.g., cuts, scrapes, wounds.
• Pregnant and/or breastfeeding.
• Having an infection, dermatitis or a rash in the treatment area.
• Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
• Suffering from coagulation disorders or taking prescription anticoagulation medications.
• History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• History of vitiligo, eczema, or psoriasis.

Sponsors & Collaborators

• Cutera Inc.: lead

Study Sites (2)

Hong Kong Dermatology and Laser Centre

Hong Kong, China

Location

Aoyama Institute of Women's Medicine

Tokyo, Japan

Location

MeSH Terms

Conditions

Melanosis; Lentigo

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 11, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

JP (1); CN (1)