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

NCT ID: NCT02095756

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Melasma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

755nm Alexandrite laser

755nm Alexandrite laser for the treatment of melasma

Group Type: EXPERIMENTAL

755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)

Intervention Type: OTHER

Lytera Skin Brightening System (Non-hydroquinone topical therapy)

Intervention Type: OTHER

Interventions

755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)

Intervention Type: OTHER

Lytera Skin Brightening System (Non-hydroquinone topical therapy)

Intervention Type: OTHER

Eligibility Criteria

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

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cynosure, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

San Diego, California, United States

Countries

United States

Other Identifiers

PICO-2013-01

Identifier Type: -

Identifier Source: org_study_id