Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376110
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-17
Brief Title:
Single-Blind Study Assessing the Use of a Topical Antioxidant With A Series of Laser Procedures to Reduce Sebum Production
Sponsor:
Austin Institute for Clinical Research
Organization:
Austin Institute for Clinical Research
Study Overview
Official Title:
A Split-Face Single-Blind Study Assessing the Use of a Topical Antioxidant Containing Silymarin With A Series of 1726nm Laser Procedures to Reduce Sebum Production
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a split-face single-blind study assessing the use of an antioxidant serum with a series of acne laser treatments to reduce sebum production in healthy male and female subjects between the ages of 18 and 65 years inclusive with Fitzpatrick skin types I-VI
Detailed Description:
A single-center study Clinical efficacy will be assessed using Investigator Global Assessment IGA Instrumentation will be assessed using VISIA imaging procedures and sebumeter sebum production Tolerability will be assessed in subjects through objective tolerance grading and subjective tolerance assessment In addition subject perception of product will be evaluated by questionnaires Live investigator clinical efficacy grading tolerance evaluations and subject self-assessments will be performed at baseline Day 0 Day 14 Day 42 and Day 70 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 sebumeter 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 14 42 and 70 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 Sponsors request SGS will submit the draft report to the Sponsor 20-30 business days after approval of al 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 10 subjects are planned to be enrolled Subjects who met the specified inclusionexclusion criteria will be randomized to receive the topical antioxidant 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 the first acne laser treatment to the entire face Additional laser treatments and subject visits occur on Days 42 and 70 with the final follow-up visit on Day 98 All evaluations will be done in a single-blind fashion Clinical efficacy endpoints will be evaluated on Days 14 42 70 and 98 Tolerance endpoints will be evaluated on Days 0 14 42 and 70 Physician assessments sebumeter readings patient-reported outcomes and 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 subjects 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 sites 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 The 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
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 sebumeter 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 14 42 and 70 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 Sponsors request SGS will submit the draft report to the Sponsor 20-30 business days after approval of al 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 10 subjects are planned to be enrolled Subjects who met the specified inclusionexclusion criteria will be randomized to receive the topical antioxidant 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 the first acne laser treatment to the entire face Additional laser treatments and subject visits occur on Days 42 and 70 with the final follow-up visit on Day 98 All evaluations will be done in a single-blind fashion Clinical efficacy endpoints will be evaluated on Days 14 42 70 and 98 Tolerance endpoints will be evaluated on Days 0 14 42 and 70 Physician assessments sebumeter readings patient-reported outcomes and 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 subjects 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 sites 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 The 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None