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Skin LaxityEACpLfe22S01NCT06674005

Cucurbita Pepo Flowers Extract to Promote Skin Health

A study testing Cucurbita pepo L. Flowers Extract in people with Skin Laxity and Skin Aging, run by Ritamaria Di Lorenzo at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Laxity, Skin Aging, Skin Wrinkling
What is being tested?
Cucurbita pepo L. Flowers Extract
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteItaly
Study dates
1 Oct 2022to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University of Naples Federico II

    Naples, 80145

Other trials in Italy

About this study

Official title: Clinical Trial for the Evaluation of Cucurbita Pepo Flowers Extract to Promote Skin Health

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.

Read more

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

Read the 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.

Being tested
Cucurbita pepo L. Flowers Extract, Placebo
Keywords
skin health, wrinkles, collagen, skin resilience
Medical subject headings
Cutis Laxa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cucurbita pepo L. Flowers ExtractOther

    2 mg twice per day for 1 month

  • PlaceboOther

    2 mg twice per day for 1 month

Study groups in NCT06674005
Study groupRoleWhat they receive
CpLfeActive comparatorCucurbita pepo L. flower extract at 0.5% w/w in a cosmetic emulgel twice per day for 4 weeks
Receives: Other: Cucurbita pepo L. Flowers Extract
PlaceboPlacebo comparatorcosmetic emulgel twice without the active comparatore twice per day for 4 weeks
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. skin hydration

    skin moisture level was measured by Corneometer CM 825 after 2 and 4 weeks of treatment

    Measured: one month

  2. trans epidermal water loss

    skin trans epidermal water loss was measured with Tewameter TM 300 after 2 and 4 weeks of treatment

    Measured: one month

  3. collagen production

    dermal collagen was measured with Dermasca C - Probe Ultrasound after 2 and 4 weeks of treatment

    Measured: one month

Secondary outcomes (2)
  1. Skin luminosity

    skin brightness was measured with Skin-Colorimeter CL 400 (L*-value) after 2 and 4 weeks of treatment

    Measured: one month

  2. wrinkling

    skin wrinkles were detected through VISIA 7th after 2 and 4 weeks of treatment

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2024
  2. Study start1 Oct 2022
  3. Primary completion20 Dec 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06674005
Sponsor's protocol ID
PRO_CCT22S01
Other IDs
PRO_CCT22S01
Acronym
EACpLfe22S01
Status last verified
Nov 2024
First submitted
1 Nov 2024
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: informed consents and results

Questions about this trial

What is this clinical trial studying?

A study testing Cucurbita pepo L. Flowers Extract in people with Skin Laxity and Skin Aging, run by Ritamaria Di Lorenzo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

skin hydration (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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