Eczeva Supplementation and Skin Health

NCT ID: NCT07049770

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-05-31

Brief Summary

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Eczema, also known as atopic dermatitis, is a chronic skin condition characterized by inflamed, itchy, and often dry skin. It commonly affects individuals of all ages, although it frequently begins during childhood. The causes of eczema are multifactorial, including genetic, immune, and environmental factors. Genetic mutations, such as those in the FLG gene responsible for producing filaggrin, a protein vital to skin barrier function, play a significant role (1). Immune system dysregulation, particularly an overactive response to environmental allergens, also contributes to eczema (2). Environmental triggers are diverse and include irritants like soaps, detergents, and disinfectants, as well as allergens such as pollen, pet dander, dust mites, mold, and certain foods (3-8). Climatic conditions, such as cold or dry air, and high humidity, can exacerbate symptoms, as can exposure to air pollution and chlorinated water in swimming pools (3-8). Specific skincare products containing allergens or irritants may worsen the condition. Other factors influencing eczema include infections (bacterial, viral, or fungal) (9), dietary triggers like dairy, nuts, eggs, and soy (10), and clothing choices, with materials like wool and synthetics or tight-fitting clothes aggravating symptoms through skin irritation and friction (11, 12).

Individuals with certain habits or characteristics are at a higher risk of developing eczema. A family history of eczema, asthma, or hay fever significantly increases the likelihood of the condition, as it suggests a genetic predisposition (13). Emotional stress and anxiety are known to trigger or worsen eczema symptoms (14), as are hormonal changes during pregnancy or menstruation, which can cause flare-ups (15). People who sweat excessively may experience irritation and aggravation of eczema, as the moisture can exacerbate inflammation (16). Smoking or exposure to cigarette smoke is another contributing factor, known to both trigger and worsen eczema (17). Those working in professions with frequent exposure to irritants or allergens, such as healthcare or cleaning, are at higher risk due to contact with harsh chemicals (18). Additionally, excessive hand washing can strip the skin of its natural moisture, leading to irritation and exacerbating eczema symptoms (18).

The main active ingredient in Eczeva is Melicope ptelefolia. Melicope ptelefolia, commonly known as Tenggek Burung, has been used for centuries in traditional herbal medicine to treat various skin conditions, including wounds, itches, and skin diseases (19). The plant is known for its high content of bioactive compounds, particularly 2,4,6-trihydroxy-3-geranyl acetophenone (tHGA) and 2,4,6-trihydroxy-3-prenyl acetophenone (tHPA). Among these, tHGA has shown significant potential due to its inhibitory effects on lipoxygenase (LOX) activity, suggesting its anti-inflammatory properties that may help in treating conditions like eczema (20). An in vitro study demonstrated that tHGA reduced inflammatory markers and enhanced the integrity of the skin barrier, both of which are crucial for managing inflammation-related conditions like eczema (21). Further research also indicated that tHGA could improve epithelial barrier function and reduce cell permeability in inflamed tissues, a key factor in treating eczema, which is characterized by an impaired skin barrier function (22). These findings highlight the therapeutic potential of Melicope ptelefolia in managing eczema through its anti-inflammatory and barrier-strengthening effects.

Research on the efficacy of Melicope ptelefolia supplements in improving skin health in human is remain largely unexplored. This study aims to determine the mechanism and effects of Eczeva supplements on improving the skin health among users.

Detailed Description

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Conditions

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Skin Eczema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This will be prospective, pre-post comparison, open-label study for a period of 20 days. FIfty subjects will be recruited in this study. The sample size calculation was based on the formula derived to determine sample size for pre-post study design (23). Total sample size needed for this study is calculated considering a type 1 error rate of 0.05, power of 80%, an expected change in standard deviation of 1.25 derived from previous study (24). The recruitment will be conducted via convenient sampling, participants will be invited via social media such as Facebook, Instagram, and WhatsApp. Participant Information Sheet (PIS) will be provided to subject, followed by consent taking before subject can access the full content of the questionnaires.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional Arm

In this arm, subjects will be required to consume Eczeva supplementation for 20 days, at the dosage of 3g once a day.

Group Type EXPERIMENTAL

Eczeva supplementation

Intervention Type DIETARY_SUPPLEMENT

Intervention contains 0.2g of eczefolia extracts, and 0.01g of rice ceramides as main active ingredients.

Interventions

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Eczeva supplementation

Intervention contains 0.2g of eczefolia extracts, and 0.01g of rice ceramides as main active ingredients.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* General healthy subject
* Aged 18 or older
* Experienced any of the following symptoms in the past 3 months:
* Skin itchiness
* Skin cracking
* Skin flaking
* Skin dryness or roughness
* Willing to comply with interventional plan
* Willing to give consent

Exclusion Criteria

* Are pregnant or lactating
* Skin allergic due to medication, contact or seafood intakes
* Have taken dietary supplements or undergone systemic immunomodulatory or immunosuppressive therapy in the past 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCSI University

OTHER

Sponsor Role collaborator

Zest Healthtech PLT

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UCSI University

Cheras, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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Sanioto SM, Aboulafia J. Lack of PCMB action upon the outer barrier sodium permeability in the absence of Na in toad skin. Pflugers Arch. 1985 Feb;403(2):115-9. doi: 10.1007/BF00584087.

Reference Type BACKGROUND
PMID: 3920642 (View on PubMed)

Other Identifiers

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ZEST001

Identifier Type: -

Identifier Source: org_study_id

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