Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616558
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
A Study to Assess the Effectiveness of Sunscreen on Oil Control Moisturization and Skin Barrier Integrity in Adults With Oily Skin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Center Open-Label Randomized Clinical Study to Evaluate the Oil Control Efficacy Moisture Assessment and Skin Barrier Integrity of an Investigational Product in Adult Participants With Oily Facial Skin
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate 1 the efficacy of an investigational product sunscreen when compared to a control area without product application in controlling oiliness oil shine and the effect on pores appearance in a 12-hour kinetics through a Instrumental measurements b Expert Grader and c Perceived efficacy 2 the efficacy of an investigational product in reducing oiliness improving hydration the pores appearance and the integrity of the skin barrier after 7 days of use and after 28 2 days of use through instrumental measurements and perceived efficacy questionnaires
Detailed Description:
The objectives of this study are
To evaluate the efficacy of an investigational product sunscreen when compared to a control area without product application in controlling oiliness oil shine and the effect on pores appearance in a 12-hour kinetics
Instrumental measurements with the Sebumeter SM 815 equipment to assess oiliness control
Clinical efficacy evaluation carried out by Expert Grader
Perceived efficacy through perception questionnaires
To evaluate the efficacy of an investigational product in reducing oiliness improving hydration pores appearance and the integrity of the skin barrier after 7 days of use and after 28 2 days of use under normal conditions of use in adult participants through the following evaluations
Instrumental measurements with the Sebumeter SM 815 equipment before and after 7 and 28 2 days of use on the face to assess oil reduction
Instrumental measurements with the Corneometer before and after 7 and 28 2 days of use on the face to assess skin hydration
Instrumental measurements with the Tewameter TM 300 before and after 7 and 28 2 days of use on the face to assess the integritymaintenance of the skin barrier
Facial images captured using Visia CR equipment before and after 7 and 28 2 days of use on the face
Perceived efficacy through perception questionnaires answered by research participants after 7 and 28 2 days of use on the face
Open-ended emotional statement after 28 2 days
To evaluate the efficacy of an investigational product sunscreen when compared to a control area without product application in controlling oiliness oil shine and the effect on pores appearance in a 12-hour kinetics
Instrumental measurements with the Sebumeter SM 815 equipment to assess oiliness control
Clinical efficacy evaluation carried out by Expert Grader
Perceived efficacy through perception questionnaires
To evaluate the efficacy of an investigational product in reducing oiliness improving hydration pores appearance and the integrity of the skin barrier after 7 days of use and after 28 2 days of use under normal conditions of use in adult participants through the following evaluations
Instrumental measurements with the Sebumeter SM 815 equipment before and after 7 and 28 2 days of use on the face to assess oil reduction
Instrumental measurements with the Corneometer before and after 7 and 28 2 days of use on the face to assess skin hydration
Instrumental measurements with the Tewameter TM 300 before and after 7 and 28 2 days of use on the face to assess the integritymaintenance of the skin barrier
Facial images captured using Visia CR equipment before and after 7 and 28 2 days of use on the face
Perceived efficacy through perception questionnaires answered by research participants after 7 and 28 2 days of use on the face
Open-ended emotional statement after 28 2 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None