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OpenTrials
Completed

NCT Number: NCT05724589

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

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.

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Key information

Conditions

Aging

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Dermatology

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidermal Growth Factor

Drug

Apply facial twice daily.

Other names: Epidermal Growth Factor Serum

Primary outcomes

  1. Facial Skin Hydration

    Time frame: 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.

  2. Transepidermal Water Loss

    Time frame: 4 months

    measured by tewameter on day 0, then at 8, 12, and 16 weeks.

  3. Facial Skin Elasticity (R2 Parameter Via Cutometer)

    Time frame: 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.

  4. Facial Skin Wrinkles

    Time frame: 4 months

    Visioscan measurements were taken at baseline, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale.

  5. Facial Melanin Index

    Time frame: 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.

  6. Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)

    Time frame: 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 outcomes

  1. Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation

    Time frame: 4 months

    Using a quartile grading system, (0 = unsatisfied), (1 = slightly satisfied), (2 = satisfied), and (3 = very satisfied)

  2. Adverse Events

    Time frame: 4 months

    Adverse events were systematically monitored at 2, 4, 8, 12, and 16 weeks post-treatment initiation.

Sponsors and collaborators

Lead sponsor

Institute of Dermatology, Thailand

Other Gov

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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