- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05724589
The Effectiveness of Epidermal Growth Factor Serum in Improve Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles.
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10400
- Institute of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Epidermal Growth Factor Serum Application
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
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Apply facial twice daily.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Facial Skin Hydration
Time Frame: 4 months (Baseline, Week 8, Week 12, Week 16)
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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.
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4 months (Baseline, Week 8, Week 12, Week 16)
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Transepidermal Water Loss
Time Frame: 4 months
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measured by tewameter on day 0, then at 8, 12, and 16 weeks.
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4 months
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Facial Skin Elasticity (R2 Parameter Via Cutometer)
Time Frame: Baseline, Week 8, Week 12, Week 16
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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.
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Baseline, Week 8, Week 12, Week 16
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Facial Skin Wrinkles
Time Frame: 4 months
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Visioscan measurements were taken at baseline, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale.
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4 months
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Facial Melanin Index
Time Frame: 4 months
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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.
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4 months
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Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
Time Frame: 4 months
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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%). |
4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
Time Frame: 4 months
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Using a quartile grading system, (0 = unsatisfied), (1 = slightly satisfied), (2 = satisfied), and (3 = very satisfied)
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4 months
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Adverse Events
Time Frame: 4 months
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Adverse events were systematically monitored at 2, 4, 8, 12, and 16 weeks post-treatment initiation.
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4 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chumsaeng Chumsaengsri, Institute of Dermatology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 008/2565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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