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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02385994
• Date of registration: 03/03/2015
• Prospective Registration: Yes
• Primary sponsor: Cutera Inc.
• Public title: A Prospective Multi-Center Study Using Laser for the Treatment of Melasma and Lentigines in Asian Skin
• Scientific 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
• Date of first enrolment: April 2015
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02385994
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China, Japan

Contacts

• Name: Henry Hin-Lee Chan, M.D., Ph.D
• Affiliation: Hong Kong Dermatology and Laser Centre

• Name: Kei Negishi, M.D., Ph.D
• Affiliation: Tokyo Women's Medical University

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Melasma

Lentigines

Intervention(s)

Device: enLighten Laser

Primary Outcome(s)

Investigator Assessment measured by 5-point improvement scale [Time Frame: 12 weeks]

Secondary Outcome(s)

Melasma Subject's MASI Improvement [Time Frame: 12 weeks]

Pain and Adverse Events [Time Frame: Day 1]

Subject Assessment measured by 5-point improvement scale [Time Frame: 12 weeks]

Relative Melanin Index [Time Frame: 12 weeks]

Secondary ID(s)

C-14-EN01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors