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

Not Applicable

Completed

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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
Facial Skin Hydration	4 months (Baseline, Week 8, Week 12, Week 16)	Facial skin hydration was measured using a Corneometer, which provides readings in arbitrary units (a.u.). Measurements were taken at baseline (Day 0), Week 8, Week 12, and Week 16 under standardized environmental and procedural conditions to ensure reliability and accuracy. Higher values indicate better skin hydration, while lower values indicate increased dryness.
Transepidermal Water Loss	4 months	measured by tewameter on day 0, then at 8, 12, and 16 weeks.
Facial Skin Elasticity (R2 Parameter Via Cutometer)	Baseline, Week 8, Week 12, Week 16	Skin elasticity was assessed using a Cutometer with the R2 parameter (Ua/Uf), which measures gross elasticity. R2 values range from 0 to 1.0, with higher values indicating better skin elasticity. Measurements were collected under standardized conditions at Baseline (Day 0), Week 8, Week 12, and Week 16.
Facial Skin Wrinkles	4 months	Visioscan measurements were taken at baseline, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale.
Facial Melanin Index	4 months	Facial pigmentation was assessed using the Mexameter, which measures melanin content via light absorption and reflection. The device reports values on a scale from 0 to 999, where higher values represent greater melanin concentration. Measurements were collected at standardized facial sites at Baseline, Week 8, Week 12, and Week 16. Higher scores indicate worse pigmentation.
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)	4 months	Facial skin appearance was evaluated using the Subject Global Aesthetic Improvement Scale (SGAIS), a 5-point scale where higher scores indicate greater improvement. Scores were assigned by two board-certified dermatologists who assessed photographs taken by the Visia-CR imaging system at Baseline, Week 8, Week 12, and Week 16. SGAIS scoring definition: 1 = Worse, 2 = Mild improvement (\<25%), 3 = Moderate (25-49%), 4 = Much improved (50-74%), 5 = Very much improved (≥75%).

Secondary Outcome Measures

Name	Time	Method
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)
Adverse Events	4 months	Adverse events were systematically monitored at 2, 4, 8, 12, and 16 weeks post-treatment initiation.