Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06674005
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2024-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cucurbita Pepo Flowers Extract to Promote Skin Health
Sponsor:
Ritamaria Di Lorenzo
Organization:
Study Overview
Official Title:
Clinical Trial for the Evaluation of Cucurbita Pepo Flowers Extract to Promote Skin Health
Status:
COMPLETED
Status Verified Date:
2024-11
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:
EACpLfe22S01
Brief Summary:
The aim of this cosmetic clinical trial is to learn if an extract of Cucurbita pepo flower (CpLfe) works to enhance skin health and resilience in adult women with photo-damage. It will also learn about the safety of cosmetic active ingredient. The main questions it aims to answer are:
Does cosmetic active ingredient improve skin moisture, luminosity and collagen production, and reduce wrinkles visibility? What skin benefits do participants have when using this new active ingredient in a cosmetic formulation? Researchers will compare the CpLfe to a placebo (a look-alike cosmetic formulation that contains no CpLfe) to see if CpLfe works as ant anti-aging ingredient for skin health.
Participants will:
Take CpLfe or a placebo every day for 1 month Visit the clinic once every 2 weeks for checkups and tests Keep a diary of the potential adverse reactions that might result from using the assigned test products
Does cosmetic active ingredient improve skin moisture, luminosity and collagen production, and reduce wrinkles visibility? What skin benefits do participants have when using this new active ingredient in a cosmetic formulation? Researchers will compare the CpLfe to a placebo (a look-alike cosmetic formulation that contains no CpLfe) to see if CpLfe works as ant anti-aging ingredient for skin health.
Participants will:
Take CpLfe or a placebo every day for 1 month Visit the clinic once every 2 weeks for checkups and tests Keep a diary of the potential adverse reactions that might result from using the assigned test products
Detailed Description:
The skin effects of the CpLfe were evaluated through a double-blind, placebo-controlled, parallel-arm, randomized clinical study. Healthy Italian subjects (age 35-55; n=40) were enrolled in this 4-week study. Before participating, each subject signed a written informed consent that contained the aim and the type of the study, the list of the cosmetic-grade ingredient employed fort the preparation of the cosmetic formulation, the rules to be followed, and any known or potential adverse reactions that might result from using the test products.
All subjects were selected based on the presence of visible wrinkles and skin laxity. Enrolled subjects underwent a 1-week washout period, in which they were instructed to stop using their usual cosmetic products, whereas they were permitted to continue their normal facial treatment regimen (e.g., facial cleanser, make-up removal, eye and lip make-up, and foundation) that did not contain ingredients with anti-aging or lightening action. Once the wash-out period elapsed, subjects were supplied with test products (placebo and the same formulation added with CpLfe).
Panelists had to apply the assigned emulgel twice daily (morning and evening) for 4 weeks. The application amount had to be approximately 0.3 g of product (two pumps) on a dry or slightly moistened face. Massage in, avoiding direct contact with the eyes. Upon application, in case of individual hypersensitivity, discontinue treat-ment. Do not use on irritated or chapped skin. For the evening application wait for at least 1 h before bedtime.
Digital images of all subjects were captured at baseline and at weeks 2 and 4, with VISIA® 7th (Canfield Scientific Inc., Parsippany, NJ 07054 USA). The skin imaging sys-tem exploits IntelliFlash®, cross-polarized light to record and measure skin furrows, folds, and wrinkles. Before image capture, subjects were equilibrated in a controlled temperature room (22 ± 2 °C) for 30 minutes. The hair of the participants was tied up and their clothing was covered with black cloth. The images were taken by the same operator using the same imaging equipment under the same conditions (lighting, dis-tance, head position, etc.) at all time points. Accurate subjects' repositioning was ob-tained by comparing the live image with the ghost-baseline digitally stored photo. Computer analysis of the digital images allowed quantification of the main facial ex-pressive wrinkles (forehead and frown lines, nasolabial folds, and crow's feet).
Facial skin color and spots were also detected through reflectance and spectro-photometric skin devices, like Skin-Colorimeter® CL 400 and Mexameter® MX 18 (Courage+Khazaka electronic GmbH). Specifically, the skin luminosity, melanin index and skin complexion were monitored during the trial. Lastly, facial ultrasonography was carried out, to provide dermis structural organization before and after treatment to confirm the CpLfe ability to firm and densify the skin.
All subjects were selected based on the presence of visible wrinkles and skin laxity. Enrolled subjects underwent a 1-week washout period, in which they were instructed to stop using their usual cosmetic products, whereas they were permitted to continue their normal facial treatment regimen (e.g., facial cleanser, make-up removal, eye and lip make-up, and foundation) that did not contain ingredients with anti-aging or lightening action. Once the wash-out period elapsed, subjects were supplied with test products (placebo and the same formulation added with CpLfe).
Panelists had to apply the assigned emulgel twice daily (morning and evening) for 4 weeks. The application amount had to be approximately 0.3 g of product (two pumps) on a dry or slightly moistened face. Massage in, avoiding direct contact with the eyes. Upon application, in case of individual hypersensitivity, discontinue treat-ment. Do not use on irritated or chapped skin. For the evening application wait for at least 1 h before bedtime.
Digital images of all subjects were captured at baseline and at weeks 2 and 4, with VISIA® 7th (Canfield Scientific Inc., Parsippany, NJ 07054 USA). The skin imaging sys-tem exploits IntelliFlash®, cross-polarized light to record and measure skin furrows, folds, and wrinkles. Before image capture, subjects were equilibrated in a controlled temperature room (22 ± 2 °C) for 30 minutes. The hair of the participants was tied up and their clothing was covered with black cloth. The images were taken by the same operator using the same imaging equipment under the same conditions (lighting, dis-tance, head position, etc.) at all time points. Accurate subjects' repositioning was ob-tained by comparing the live image with the ghost-baseline digitally stored photo. Computer analysis of the digital images allowed quantification of the main facial ex-pressive wrinkles (forehead and frown lines, nasolabial folds, and crow's feet).
Facial skin color and spots were also detected through reflectance and spectro-photometric skin devices, like Skin-Colorimeter® CL 400 and Mexameter® MX 18 (Courage+Khazaka electronic GmbH). Specifically, the skin luminosity, melanin index and skin complexion were monitored during the trial. Lastly, facial ultrasonography was carried out, to provide dermis structural organization before and after treatment to confirm the CpLfe ability to firm and densify the skin.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PRO_CCT22S01 | OTHER | Department of Pharmacy - University of Naples Federico II | View |