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.
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.
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.
- Conditions
- Skin Laxity, Skin Aging, Skin Wrinkling
- 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 group | Role | What they receive |
|---|---|---|
| CpLfe | Active comparator | Cucurbita 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 |
| Placebo | Placebo comparator | cosmetic 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.
skin hydration
skin moisture level was measured by Corneometer CM 825 after 2 and 4 weeks of treatment
Measured: one month
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
collagen production
dermal collagen was measured with Dermasca C - Probe Ultrasound after 2 and 4 weeks of treatment
Measured: one month
Secondary outcomes (2)
Skin luminosity
skin brightness was measured with Skin-Colorimeter CL 400 (L*-value) after 2 and 4 weeks of treatment
Measured: one month
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.
- First posted5 Nov 2024
- Study start1 Oct 2022
- Primary completion20 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ritamaria Di Lorenzo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ritamaria Di Lorenzo, Federico II University
- Investigators
- Sonia Laneri, Professor, Study director, Federico II University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Evaluation of Cucurbita Pepo Flowers Extract to Promote Skin Health
- ClinicalTrials.gov ID
- NCT06674005
- Acronym / sponsor ID
- EACpLfe22S01 / PRO_CCT22S01
- Conditions
- Skin Laxity, Skin Aging, Skin Wrinkling
- Keywords
- skin health, wrinkles, collagen, skin resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ritamaria Di LorenzoUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CpLfe | Active comparator | Other: Cucurbita pepo L. Flowers ExtractCucurbita pepo L. flower extract at 0.5% w/w in a cosmetic emulgel twice per day for 4 weeks |
| Placebo | Placebo comparator | Other: Placebocosmetic emulgel twice without the active comparatore twice per day for 4 weeks |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cucurbita pepo L. Flowers Extract2 mg twice per day for 1 month | Other | CpLfe |
| Placebo2 mg twice per day for 1 month | Other | Placebo |
Primary outcome
skin hydration
Time frame: one month
skin moisture level was measured by Corneometer CM 825 after 2 and 4 weeks of treatment
trans epidermal water loss
Time frame: one month
skin trans epidermal water loss was measured with Tewameter TM 300 after 2 and 4 weeks of treatment
collagen production
Time frame: one month
dermal collagen was measured with Dermasca C - Probe Ultrasound after 2 and 4 weeks of treatment
2 secondary outcomes
Skin luminosity
Time frame: one month
wrinkling
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Yes. informed consents and results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Laneri, Professor study director
Federico II University
1 site in 1 country: see every site and its status.
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.