Placebo-Controlled Study Assessing the Use of a Novel Exfoliative Serum With A Chemical Peel to Improve Photodamage in Adults

Overview

This is a split-face, double-blind, placebo-controlled study assessing the use of a novel exfoliative serum with a chemical peel to improve photodamage in healthy female subjects between the ages of 30 and 65 years, inclusive, with Fitzpatrick skin types I-VI.

A single-center study. Clinical efficacy will be assessed using the modified Griffith's scale. Instrumentation will be assessed using VISIA imaging procedures, and TEWL (transepidermal water loss). Tolerability will be assessed in subjects through objective tolerance grading and subjective tolerance assessment. In addition, subject perception of the product will be evaluated by questionnaires. Live investigator clinical efficacy grading, tolerance evaluations, and subject self-assessments; will be performed at baseline and Days 7, 14, 21, 31, and 42. Additionally instrumentation measurements of erythema and hyperpigmentation will be calculated by digital assessments of facial photographs. All data will be collected by the clinical site and delivered to SGS in Excel files, including demographic information, clinical grading of efficacy and tolerability evaluations, Tewameter, and self-assessment questionnaire data. Data review and analyses will be performed by an independent data committee. Interim topline data will be sent to the Sponsor after Day 42. End-of-study topline data will be sent at 10 business days after study completion. A clinical study report will be drafted using an SGS report template and incorporating any documented Sponsor preferences on file with SGS. The draft report will be submitted to the Sponsor for approval prior to finalization, and revisions may be made at the Sponsor's request. SGS will submit the draft report to the Sponsor 20-30 business days after approval of all statistical analysis and receipt of study documents from the study site. Any additions and changes to the statistical analysis after study completion may delay issuance of the draft report. After receiving the draft report, the Sponsor will have 6 months to make revisions. If SGS has received no revisions or comments within 6 months, the report will be approved for finalization. Every effort will be made to send the final report to the Sponsor within 10 business days after Sponsor approval or after the 6-month period has passed. A total of 25 subjects are planned to be enrolled. Subjects who met the specified inclusion/exclusion criteria will be randomized to receive the novel exfoliative serum on one side and placebo on the other side on Day 0 of the study. On Day 14 of the study, each subject will receive a chemical peel as deemed appropriate by the Investigator and based on Fitzpatrick skin type. The chemical peel will be either TCA SmartPeel or Micropeel 30, per Investigator prerogative based on subject's skin sensitivity. For subject with Fitzpatrick Skin Type of IV-VI will receive the Micropeel. Following the chemical peel all subjects will discontinue use of the placebo and novel exfoliative serum. On Day 21, facial skin will be examined by the Investigator in-office to determine if each subject may resume the Day 0 randomized treatment regimen. All evaluations will be done in a double-blind fashion. Clinical efficacy endpoints will be evaluated on Days 7, 14, 21, 31 and 42. Tolerance endpoints will be evaluated on Days 14, 21, 31 and 42. In addition, tolerability will be evaluated on Day 16 via tele-visit (phone call). Physician assessments, patient-reported outcomes, and digital assessments of photographs will be captured during this study. 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. If a subject is withdrawn from treatment due to an AE, 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. If a subject withdraws prior to or during the procedure, an additional subject may be enrolled to replace the withdrawn subject. The sponsor may elect to close the trial at any time during the course of the study. Any data collected prior to termination may be analyzed as specified in the protocol. The Investigator will probe, via discussion with the subject, for the occurrence of AEs (adverse events) during each subject visit and record the information in the site's source documents. Adverse events will be recorded in the subject CRF (case report form). Adverse events will be described by duration (start and stop dates and times), severity, outcome, treatment and relation to study drug, or if unrelated, the cause. Study site will document all SAEs (serious adverse events) that occur (whether or not related to study treatment). The collection period for all SAEs will begin after informed consent is obtained and end after procedures for the final study visit have been completed.

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Interventions

Eligibility

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Outcomes