| Eligibility |
Inclusion Criteria:
- 1. Females age 18-65, Fitzpatrick skin types I-VI 2. Mild to moderate melasma 3. Half
of subjects with hypervascular melasma identified by Visia complexion analysis 4.
Willingness and ability to provide written informed consent and HIPAA authorization
prior to performance of any study-related procedures.
5. Willingness to abstain from any other procedures to the areas to be treated
throughout the trial period.
6. Willingness and ability to comply with protocol requirements, including adherence
to photography and returning for follow-up visits.
7. Women of childbearing potential willing to use an acceptable form of birth control
during trial period.
1. Hormonal contraception - pill, injection, implant, patch, vaginal ring,
Intrauterine device
2. Intrauterine coil
3. Barrier method used with an additional form of contraception (e.g., sponge,
spermicide or condom)
4. Abstinence (If practicing abstinence must agree to use barrier method described
above (c) if becomes sexually active).
5. Vasectomized partner (Must agree to use barrier method described above (c) if
becomes sexually active with an Un-Vasectomized partner).
8. Female patients will be either of non-childbearing potential defined as:
Having no uterus and/or both ovaries, postmenopausal (no menses for at least 12
months prior), or has had a bilateral tubal ligation at least 6 months prior to
study enrollment.
Exclusion Criteria:
- 1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the
trial.
2. Known hypersensitivity or allergy to the components of the study medication. 3.
Concurrent enrollment in any study involving the use of investigational devices or
drugs.
4. Current smoker or history of smoking in the last five years. 5. Current user of any
nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches,
etc.
6. Presence of an active systemic or local skin disease that may affect treatment
area.
7. History of the following cosmetic treatments to the area(s) to be treated:
1. Energy based device or laser procedure to the area within the past 6 months
(Ultherapy, ablative and non-ablative laser, intense pulsed light, etc)
2. Medium to deep chemical peels (e.g. TCA, Phenol) for 6 months or light chemical
peels (e.g. Glycolic Acid >20%) within the past 3 months; 8. History of using the
following cosmetic, OTC or prescription medications:
a. Topical glycolic acid (5% or greater) in the past 4 weeks. b. Topical or oral
tranexamic acid within in the past 4 weeks (e.g. Lytera 2.0); c. Topical Retinoids
(e.g. Rx tretinoin or OTC retinol) within the past four weeks; d. Topical hydroquinone
within the past 4 weeks; e. Topical salicylic acid within the past 4 weeks; f. Topical
or oral corticosteroids within the past 4 weeks; g. Other topical products intended to
treat melasma within the past 4 weeks; 9. Individuals who started hormone replacement
therapies (HRT) or hormones for birth control less than 3 months prior to study entry
or who plan on starting, stopping, or changing doses of HRT or hormones for birth
control during the study.
10. Any planned surgical intervention to the treatment area for the duration of the
trial 11. Any visible surface alteration to the treatment area that may interfere with
evaluation, at investigator discretion 12. Any pre-existing medical condition that may
interfere with study compliance or evaluation, at investigator discretion 13.
Inability to comply with all study protocols and regulations 14. Current taking an
immunosuppressant or applying a topical corticosteroid to the affected area
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