Cucurbita Pepo Flowers Extract to Promote Skin Health

NCT06674005 | Completed DMC

• 1 other identifier: PRO_CCT22S01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Laxity; Skin Aging; Skin Wrinkling

Keywords

skin health; wrinkles; collagen; skin resilience

Outcome Measures

Primary Outcomes (3)

• skin hydration

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

  one month

• trans epidermal water loss

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

  one month

• collagen production

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

  one month

Secondary Outcomes (2)

• Skin luminosity

  one month

• wrinkling

  one month

Study Arms (2)

CpLfe

ACTIVE COMPARATOR

Cucurbita pepo L. flower extract at 0.5% w/w in a cosmetic emulgel twice per day for 4 weeks

Other: Cucurbita pepo L. Flowers Extract

Placebo

PLACEBO COMPARATOR

cosmetic emulgel twice without the active comparatore twice per day for 4 weeks

Other: Placebo

Interventions

Cucurbita pepo L. Flowers Extract OTHER

2 mg twice per day for 1 month

CpLfe

Placebo OTHER

2 mg twice per day for 1 month

Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ritamaria Di Lorenzo: lead

Study Sites (1)

University of Naples Federico II

Napoli, 80145, Italy

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Sonia Laneri, Professor

  Federico II University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 5, 2024
• Study Start: October 1, 2022
• Primary Completion: December 20, 2022
• Study Completion: January 31, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: one year

Locations

IT (1)