Clinical trial NCT06674005: Cucurbita Pepo Flowers Extract to Promote Skin Health
Official title: Clinical Trial for the Evaluation of Cucurbita Pepo Flowers Extract to Promote Skin Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Laxity
Skin Aging
Skin Wrinkling
Keywords: skin health
wrinkles
collagen
skin resilience
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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.

Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian subjects aged between 35 and 55 y.o.
* Subjects with dull and grey face, lack of firmness, wrinkles, uneven complexion
* Subjects who have read and signed the informed consent
* Subjects who agreed not to apply other products to the test area during the study period
* Subjects who agreed to follow the study procedures and the planned follow-up visits
* Subjects who not change their lifestyle (dermatological and aesthetic medice treatments)
* Absence of systemic pathologies
* Subjects with a good general state of health

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Subjects under 35 and over 55 y.o.
* Subjects with a history of skin hyper-reactivity or intolerance reactions to cosmetic products/ingredients
* Subjects with pathologies in the period immediately preceding the current study
* Subjects undergoing topical or systemic treatment with any drug that may affect the outcome of the test
* Subjects suffering from skin diseases (eczema, psoriasis, lesions)
* Subjects who have undergone dermatological or aesthetic treatments in the six months prior to their recruitment

Primary outcomes:
measure: skin hydration
timeFrame: one month
measure: trans epidermal water loss
timeFrame: one month
measure: collagen production
timeFrame: one month
Secondary outcomes:
measure: Skin luminosity
timeFrame: one month
measure: wrinkling
timeFrame: one month
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Naples Federico II
Study officials:
affiliation: Federico II University
name: Sonia Laneri, Professor
role: STUDY_DIRECTOR
References: