This is a Single-Site, open-label, randomized clinical study that aims to evaluate the efficacy of the investigational product in improving the signs of skin aging and reducing facial oiliness in a population from 30 to 55 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
73
The application of the Investigational Product will be performed by the participant and supervised by a qualified technician at Visit 1 and by the participant in their home. Home use: The Investigational Product will be applied topically by the participant, following the following mode of use: "Apply an abundant amount (equivalent to one teaspoon) daily to the face and neck, at least twice a day, with reapplications whenever necessary."
CIDP do Brasil Pesquisas Clínicas LTDA
Rio de Janeiro, Brazil
Clinical efficacy of the use of Investigational Product on signs of facial aging via dermatological evaluation
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of wrinkles, fine lines and roughness of the skin through the dermatological clinical evaluation of wrinkles, fine lines, and skin roughness parameters using the modified 10-point Griffith scale (from 0 to 9).
Time frame: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of Investigational Product in reducing skin oiliness via dermatological evaluation
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of oiliness, reduction of oiliness shine, reduction of the appearance of pores through the dermatological clinical efficacy of oil shine using the modified 10-point Griffith scale (from 0 to 9).
Time frame: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of Investigational Product in reducing pores
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of the appearance of pores through the dermatological clinical efficacy of pore appearance via modified 10-point Griffith scale (from 0 to 9).
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Efficacy perceived by the participant through a questionnaire assessment
Efficacy measured by the participant through a questionnaire evaluating: * clinical efficacy of the use of Investigational Product on signs of facial aging * clinical efficacy of Investigational Product in reducing skin oiliness * clinical efficacy of Investigational Product in reducing pores
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of the use of Investigational Product on signs of facial aging
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Facial image captures using the COLORFACE equipment.
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of the use of Investigational Product on signs of facial aging via image analysis
It is expected to obtain statistical improvement (p≤0.05) in the evaluated equipment described below: \- Evaluation of the facial images by the ANTERA 3D equipment.
Time frame: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
Clinical efficacy of Investigational Product in reducing skin oiliness via instrumental measurements
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of oiliness through the equipment below: * Instrumental measurements with the Sebumeter® equipment.
Time frame: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
The clinical efficacy of Investigational Product in maintaining skin hydration
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes, such as skin hydration through the equipment and evaluations described below: \- To evaluate the clinical efficacy of Investigational Product in maintaining skin hydration, by measurements with Corneometer® equipment.
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
The clinical efficacy of Investigational Product in maintaining the skin barrier
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes, such as reduction and/or maintenance of trans epidermal water loss through the equipment and evaluations described below: \- To evaluate the clinical efficacy of Investigational Product in maintaining trans epidermal water loss with Tewameter equipment.
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use