Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-30 @ 8:17 PM
Study NCT ID:
NCT06616558
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effectiveness of Sunscreen on Oil Control, Moisturization, and Skin Barrier Integrity in Adults With Oily Skin
Sponsor:
JNTL Consumer Health (Brasil) LTDA
Organization:
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:
False
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 integrity/maintenance 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 integrity/maintenance 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: