A Phase 4, Single-Site Study Assessing Improvement of Skin Discoloration and Texture With Combination Treatment of Novel Moisturizer and Non-Ablative Laser Treatment Inclusive of Fitzpatrick Skin Types I-VI and Asian Descent

A single-site study that will enroll approximately 40 healthy female subjects, 25 to 70 years old, who meet all the inclusion and none of the exclusion criteria will be eligible to participate in this study subjects. The study population will include 15 patients with Fitzpatrick Skin Type I-III, 10 patients with Fitzpatrick Skin Type IV-VI, and 15 patients of Asian descent. The study duration is 14 weeks (98 days) including 6 study visits. This study's objective is to evaluate both the tolerability and improvement in signs of photoaging for a placebo moisturizer used in combination with a non-ablative laser. Physician assessments, patient reported outcomes, and digital photos will be captured. Clinical Efficacy endpoints will be evaluated at Day 0 (Baseline), Day 14 (Procedure), Day 28, Day 42, Day 70, and Day 98. Clinical efficacy assessments include Live Clinical Investigator Assessment, Redness, Skin Clarity, Appearance of Pores, Skin Texture/Smoothness (Visual), Skin Texture/Smoothness (Tactile), Hyperpigmentation, Skin Tone Evenness, Radiance/Brightness and Overall Healthy Appearance of Skin/Overall Skin Quality. The Modified Griffith's Scale will also be included. Tolerance endpoints will be evaluated at Day 0, Day 14 (Procedure), Day 28, Day 42, Day 70, and Day 98 including Objective Tolerance Evaluation and Subject Self-Assessment Tolerance. Instrumentation will be captured at Day 0 (Baseline), Day 14 (Procedure), Day 28, Day 42, Day 70, and Day 98 by VISIA Imaging Procedures (Canfield Imaging Systems) Before/After Photos. Subject Self-assessment Improvement and Product Use will be evaluated at Day 14 (Procedure), Day 28, Day 42, Day 70, and Day 98.

All participating subjects will receive the Phyto A+ Brightening Treatment (Pre-Treatment) and placebo prior to receiving the Fitzpatrick Skin Type (FST) appropriate laser treatment, as determined by the Investigator. On Day 14 subjects will be treated with a non-ablative based device treatment, Sciton or LaseMD. The LaseMD Laser allows nearly pain free treatments with depth of 200 μm setting multiple microbeams. The stratum corneum stays intact despite superficial ruptures, coagulation zones appear only in the underlying layers of the skin. The Sciton Laser uses a broad band of noncoherent light waves that are absorbed by a number of components in the skin, leading to a reduction in dyschromia, background erythema, telangiectasia, and an increase in collagen production resulting in amelioration of fine lines.

The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of study personnel during study visits and interviews of a study participant presenting for medical care, or upon review by a study monitor. All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the appropriate case report form (CRF). Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study must be documented appropriately regardless of relationship. Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of each episode. Site staff will record all reportable events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. All AE/SAEs will be followed for outcome information until resolution or stabilization. In accordance with the standard operating procedures and policies of the local Institutional Review Board (IRB), the site investigator will report SAEs to the IRB.

Protocol deviations will be captured and recorded when the subject, Investigator, or Sponsor fails to adhere to significant protocol requirements affecting the inclusion, exclusion, subject safety and primary endpoint criteria. Protocol deviations for this study include, but are not limited to, failure to meet inclusion/exclusion criteria. All significant protocol deviations will be reported to the IRB, in accordance with the standard operating procedures and policies of the local Institutional Review Board (IRB).

A subject may be discontinued from study treatment at any time if the subject, the Investigator, or the Sponsor feels that it is not in the subject's best interest to continue. The following possible reasons for study treatment discontinuation include Subject withdrawal of consent, Subject is not compliant with study procedures, Adverse event that in the opinion of the investigator would be in the best interest of the subject to discontinue study treatment, Protocol violation requiring discontinuation of study treatment, Lost to follow-up, Sponsor request for early termination of study, and Positive pregnancy test. If a subject is withdrawn from treatment due to an Adverse Event, the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized. All subjects who discontinue study treatment should come in for an early discontinuation visit as soon as possible and then should be encouraged to complete all remaining scheduled visits and procedures. All subjects are free to withdraw from participation at any time, for any reason, specified or unspecified, and without prejudice. Reasonable attempts will be made by the Investigator to provide a reason for subject withdrawals. The reason for the subject's withdrawal from the study will be specified in the subject's source documents.