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

Aging Clinical Trial

Official title:

The Effectiveness of Epidermal Growth Factor Serum for the Improvement of Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles at the Institute of Dermatology: a Single-centered Pilot Study With a One-group Before-and-after Design

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05724589
• Other study ID #: 008/2565
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: January 12, 2024

Study information

• Verified date: January 2024
• Source: Institute of Dermatology, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 12, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Epidermal Growth Factor
Apply facial twice daily.

Locations

Country	Name	City	State
Thailand	Institute of Dermatology	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Dermatology, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial skin hydration	measured by corneometer in arbitrary units (a.u.) on day 0, then 8, 12, and 16 weeks.	4 months
Primary	Transepidermal water loss	measured by tewameter in g/m2xh on day 0, then at 8, 12, and 16 weeks.	4 months
Primary	Facial skin elasticity	measured by the cutometer on day 0, then at 8, 12, and 16 weeks.	4 months
Primary	Facial skin wrinkles	Visioscan measurements were taken at day 0, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale.	4 months
Primary	Facial skin pigmentation	measured by mexameter on day 0, then at 8, 12, and 16 weeks.	4 months
Primary	Overall facial skin photograph	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.	4 months
Secondary	Subject satisfaction in improving skin hydration, elasticity, wrinkles, and pigmentation	Using a quartile grading system, (0 = unsatisfied), (1 = slightly satisfied), (2 = satisfied), and (3 = very satisfied)	4 months
Secondary	Adverse effects	Clinical follow-up at 2, 4, 8, 12, and 16 weeks	4 months