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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05724589
Other study ID # 008/2565
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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