Combination Alexandrite Laser and Topical Therapy vs Topical Therapy Alone for Treatment of Melasma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of a combination of non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone for the treatment of facial melasma.

Official Title
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A Randomized, Split-Face, Double-Blind Clinical Pilot Study of Combination Picosecond Alexandrite Laser and Non-Hydroquinone Topical Therapy Versus Topical Therapy Alone for the Treatment of Facial Melasma

Conditions
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Melasma

Intervention / Treatment
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* Other: 755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)
* Other: Lytera Skin Brightening System (Non-hydroquinone topical therapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Subjects aged 18-74 years of age; Fitzpatrick Skin Types I-IV; Female subjects of childbearing potential must have a negative urine pregnancy test at the beginning of the study, and agree to practice appropriate birth-control to prevent pregnancy during the study. The type and dose of birth control must have been stable for at least 3 months prior to study entry and it is not expected to change during the study; acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplant®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active. Subjects diagnosed with moderate to severe melasma on both sides of the face For subjects using medication to treat a concurrent medical condition, type and dose must have been stable for at least 3 months prior to study entry and it is not expected to change during the study (except any medications specifically outlined in the exclusion criteria section) Subjects able to avoid prolonged sun exposure on the face for the duration of the study and willing to use appropriate sun avoidance techniques. Subjects able to follow study instructions and likely to complete all required visits; Subjects/Representative able and willing to sign the Informed Consent (which includes a photography release) prior to any study procedures. Exclusion Criteria: Female subjects who are pregnant, nursing or planning a pregnancy during the course of the study; Subjects with a condition or who are in a situation which, in the Investigator's opinion, may put the Subject at risk, may confound the study results, or may interfere with the Subject's participation in the study, such as: the use of a concomitant medication that can interfere with the study or worsen any condition when used during the study, the use of medications known to induce photosensitivity; Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study regimen (e.g. eczema, psoriasis, severe sun-damage, dermatitis) and/or have scarring or infection of the area to be treated; Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma, etc.) in the areas to be treated; Subject unwilling to avoid any other treatment for melasma during the study (total duration of 30 weeks); Subjects with a wash-out period of less than 14 days for melasma treatments at the time of study entry or under current treatment; Subjects with prior facial resurfacing, deep or chemical peels within 6 months of the date of study entry; Subject unwilling to refrain from any facial cosmetic procedures during the study period (e.g., chemical peels, resurfacing, microdermabrasion, etc.); Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study; Subject has participated in a clinical research study within the last 30 days prior to enrollment; Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or other reasons; Subject is unable to meet the study attendance requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 755nm Alexandrite laser<br>755nm Alexandrite laser for the treatment of melasma | Other: 755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)<br> <br> Other: Lytera Skin Brightening System (Non-hydroquinone topical therapy)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melasma clearance | Evaluate the efficacy of a combination of non-hydroquinone topical therapy and a 755-nm alexandrite laser compared to topical therapy alone in the treatment of melasma . | up to 3 months post last treatment |