Melasma
Conditions
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.
Interventions
OTHER755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)
OTHERLytera Skin Brightening System (Non-hydroquinone topical therapy)
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melasma clearance | up to 3 months post last treatment | 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 . |
Countries
United States
Outcome results
None listed