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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
Sponsor:
Information provided by (Responsible Party):
Cutera Inc.

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.

Condition or disease Intervention/treatment Phase
Melasma Lentigines Device: enLighten Laser Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
  • History of seizure disorders due to light.
  • Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
  • History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
  • History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
  • History of hormone treatment, such as estrogen, progesterone and/or oral contraceptives, initiated within 3 months of study participation, or planning to discontinue hormone therapy during the study, as applicable.
  • Systemic use of any prescription skin-lightening agent (such as tranexamic acid), isotretinoin (or other retinoid), photo-sensitizing medication, or corticosteroid within 6 months of and during study participation, except if the subject undergoes a 6-month wash-out period of excluded systemic prescriptions prior to first laser treatment.
  • Topical use of any prescription skin-lightening agent (such as hydroquinone), isotretinoin (or other retinoid), photo-sensitizing medication, or corticosteroid on the treatment area within 6 months of and during study participation, except permitted topical steroid use as directed by study doctor and if subject undergoes a 6-month wash-out period of excluded topical prescriptions prior to first laser treatment.
  • Anytime in life, had used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
  • Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
  • As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Information from the National Library of Medicine

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


Locations
China
Hong Kong Dermatology and Laser Centre
Hong Kong, China
Japan
Aoyama Institute of Women's Medicine
Tokyo, Japan
Sponsors and Collaborators
Cutera Inc.
Investigators
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

Responsible Party: Cutera Inc.
ClinicalTrials.gov Identifier: NCT02385994     History of Changes
Other Study ID Numbers: C-14-EN01
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Melanosis
Lentigo
Hyperpigmentation
Pigmentation Disorders
Skin Diseases