The Effectiveness of Epidermal Growth Factor Serum in Improve Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles.

Not Applicable

Active, not recruiting

• Conditions: Aging
• Interventions: Drug: Epidermal Growth Factor

• Registration Number: NCT05724589
• Lead Sponsor: Institute of Dermatology, Thailand

Brief Summary

EGF is a polypeptide that promotes cell differentiation and collagen production while decreasing melanin production. This study is designed to study its effectiveness in improving the texture and appearance of facial skin after daily topical application. We hypothesized that EGF would improve facial skin hydration, elasticity, pigmentation, and wrinkles.

Detailed Description

All patients gave written informed consent for epidermal growth factor serum application on the face. The pilot study enrolls thirty patients compared to pre and post-serum used to evaluate facial skin hydration, transepidermal water loss, elasticity, pigmentation, and wrinkles measured by corneometer, tewameter, cutometer, visioscan, and mexameter respectively on day 0, then 8, 12, and 16 weeks. The study evaluates subject satisfaction and side effects after serum application as secondary outcomes.

Study Timeline

• Study Start: 2023-01-30
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-13
• Status Verified: 2024-01
• Primary Completion: 2024-01-05
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09
• Study Completion: 2024-01-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Thai
• Mild to moderate facial skin condition, as measured by 1-2 points on the hyperpigmentation status scale or 2-3 points on the wrinkle severity grading scale.

Exclusion Criteria

• Use of lotions or skin care products containing ingredients such as vitamin A/C, hydroquinone, or anti-aging agents.
• Sunbathing
• Hypersensitivity to serum components
• Pregnancy and breast-feeding
• Active skin diseases such as eczema or atopic dermatitis at the application site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidermal Growth Factor Serum Application	Epidermal Growth Factor	Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.

Primary Outcome Measures

Name	Time	Method
Transepidermal water loss	4 months	measured by tewameter in g/m2xh on day 0, then at 8, 12, and 16 weeks.
Facial skin hydration	4 months	measured by corneometer in arbitrary units (a.u.) on day 0, then 8, 12, and 16 weeks.
Facial skin elasticity	4 months	measured by the cutometer on day 0, then at 8, 12, and 16 weeks.
Facial skin wrinkles	4 months	Visioscan measurements were taken at day 0, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale.
Facial skin pigmentation	4 months	measured by mexameter on day 0, then at 8, 12, and 16 weeks.
Overall facial skin photograph	4 months	Using the subject global aesthetic improvement scale, two board-certified dermatologists evaluated a photo taken with Visia-CR on day 0, then at 8, 12, and 16 weeks.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	4 months	Clinical follow-up at 2, 4, 8, 12, and 16 weeks
Subject satisfaction in improving skin hydration, elasticity, wrinkles, and pigmentation	4 months	Using a quartile grading system, (0 = unsatisfied), (1 = slightly satisfied), (2 = satisfied), and (3 = very satisfied)

Trial Locations

Locations (1)

Institute of Dermatology; 🇹🇭 Bangkok, Thailand