CIDP do Brasil Pesquisas Clínicas LTDA
Rio de Janeiro, 20231-048, Brazil
NCT Number: NCT07310706
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.
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Notify Me30 year–55 year
All sexes
Interventional
Not applicable
Rio de Janeiro, 20231-048, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
I. Fitzpatrick I and II: at least 8 participants II. Fitzpatrick III and IV: at least 8 participants III. Fitzpatrick V and VI: at least 8 participants
I. Fine lines II. Wrinkles III. Roughness/uneven texture
Exclusion criteria
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."
Time frame: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
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
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) and Visit 3 (56 ± 2 days ) of IP use
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 measured by the participant through a questionnaire evaluating:
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
Facial image captures using the COLORFACE equipment.
Time frame: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
It is expected to obtain statistical improvement (p≤0.05) in the evaluated equipment described below:
Time frame: Before and after Visit 1 (Day 0), Visit 2 (28 ± 2 days) and Visit 3 (56 ± 2 days ) of IP use
It is expected to obtain statistical improvement (p≤0.05) in the evaluated attributes such as reduction of oiliness through the equipment below:
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
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:
Time frame: Before and after Visit 1 (Day 0) and Visit 3 (56 ± 2 days ) of IP use
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:
Kenvue Brands LLC
Industry
Eight-Week, Single-Site Study to Evaluate the Efficacy of a Facial Sunscreen in Adult Participants With Oily Skin and Signs of Aging
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.