Trial Outcomes & Findings for The Effectiveness of Epidermal Growth Factor Serum in Improve Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles. (NCT NCT05724589)
NCT ID: NCT05724589
Last Updated: 2025-07-31
Results Overview
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.
COMPLETED
NA
28 participants
4 months (Baseline, Week 8, Week 12, Week 16)
2025-07-31
Participant Flow
Pre-assignment Details of 28 enrolled participants, all met inclusion criteria.
Unit of analysis: face
Participant milestones
| Measure |
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.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Overall Study
STARTED
|
28 28
|
|
Overall Study
COMPLETED
|
27 27
|
|
Overall Study
NOT COMPLETED
|
1 1
|
Reasons for withdrawal
| Measure |
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.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
The Effectiveness of Epidermal Growth Factor Serum in Improve Facial Skin Hydration, Elasticity, Pigmentation, and Wrinkles.
Baseline characteristics by cohort
| Measure |
Epidermal Growth Factor Serum Application
n=28 face
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Age, Continuous
|
52 ัyears
STANDARD_DEVIATION 8.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
28 participants
n=5 Participants
|
|
Underlying disease
Hypertension
|
4 Participants
n=5 Participants
|
|
Underlying disease
Diabetes
|
2 Participants
n=5 Participants
|
|
Underlying disease
Other
|
3 Participants
n=5 Participants
|
|
Underlying disease
No
|
18 Participants
n=5 Participants
|
|
Underlying disease
No identify.
|
1 Participants
n=5 Participants
|
|
Occupation
Government employee
|
1 Participants
n=5 Participants
|
|
Occupation
Permanent employee
|
3 Participants
n=5 Participants
|
|
Occupation
Temporary employee
|
14 Participants
n=5 Participants
|
|
Occupation
Security guard
|
4 Participants
n=5 Participants
|
|
Occupation
Government officer
|
1 Participants
n=5 Participants
|
|
Occupation
Office worker
|
4 Participants
n=5 Participants
|
|
Occupation
No identify.
|
1 Participants
n=5 Participants
|
|
Fitzpatrick skin type
III
|
5 Participants
n=5 Participants
|
|
Fitzpatrick skin type
IV
|
23 Participants
n=5 Participants
|
|
Hormone use
No
|
27 Participants
n=5 Participants
|
|
Hormone use
Yes
|
1 Participants
n=5 Participants
|
|
Pregnancy
No
|
28 Participants
n=5 Participants
|
|
Pregnancy
Yes
|
0 Participants
n=5 Participants
|
|
Menopause
No
|
18 Participants
n=5 Participants
|
|
Menopause
Yes
|
10 Participants
n=5 Participants
|
|
Smoking
No
|
28 Participants
n=5 Participants
|
|
Smoking
Yes
|
0 Participants
n=5 Participants
|
|
Alcohol drinking
No
|
27 Participants
n=5 Participants
|
|
Alcohol drinking
Yes
|
1 Participants
n=5 Participants
|
|
Regular sun expose
No
|
28 Participants
n=5 Participants
|
|
Regular sun expose
Yes
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 months (Baseline, Week 8, Week 12, Week 16)Population: The analysis population included 28 subjects initially recruited for this study. Participants were assessed at four time points: baseline (Day 0), Week 8, Week 12, and Week 16. One participant was lost to follow-up after Week 12 and 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.
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 face
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Facial Skin Hydration
Baseline
|
56.043 arbitrary units
Standard Deviation 1.900
|
|
Facial Skin Hydration
8 weeks
|
58.300 arbitrary units
Standard Deviation 1.567
|
|
Facial Skin Hydration
12 weeks
|
55.852 arbitrary units
Standard Deviation 1.583
|
|
Facial Skin Hydration
16 weeks
|
58.714 arbitrary units
Standard Deviation 1.568
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The analysis population for this study on Transepidermal Water Loss (TEWL) utilizing Tewameter measurements comprised a total of 28 initially recruited subjects. These participants were assessed at four distinct time points: day 0 (baseline), 8 weeks, 12 weeks, and 16 weeks. One subject loss follow-up at week 12 and week 16.
measured by tewameter on day 0, then at 8, 12, and 16 weeks.
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 face
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Transepidermal Water Loss
Baseline
|
11.815 g/m²·h
Standard Deviation 1.221
|
|
Transepidermal Water Loss
8 weeks
|
8.761 g/m²·h
Standard Deviation 0.623
|
|
Transepidermal Water Loss
12 weeks
|
8.400 g/m²·h
Standard Deviation 0.516
|
|
Transepidermal Water Loss
16 weeks
|
8.160 g/m²·h
Standard Deviation 0.559
|
PRIMARY outcome
Timeframe: Baseline, Week 8, Week 12, Week 16Population: 28 participants were assessed at Baseline and Week 8. One participant was lost to follow-up after Week 8, resulting in 27 participants at Weeks 12 and 16. Skin elasticity was measured using the R2 parameter from Cutometer readings at each time point.
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.
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 face
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Facial Skin Elasticity (R2 Parameter Via Cutometer)
Baseline
|
0.596 units on a scale
Standard Deviation 0.016
|
|
Facial Skin Elasticity (R2 Parameter Via Cutometer)
8 wk
|
0.596 units on a scale
Standard Deviation 0.013
|
|
Facial Skin Elasticity (R2 Parameter Via Cutometer)
12 wk
|
0.584 units on a scale
Standard Deviation 0.012
|
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Facial Skin Elasticity (R2 Parameter Via Cutometer)
16 wk
|
0.553 units on a scale
Standard Deviation 0.014
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The analysis population for this study on facial skin wrinkles using Visioscan included 28 subjects, assessed at Day 0 (baseline), Week 8, Week 12, and Week 16. One subject dropped out at Week 12 and another at Week 16, leaving data from 27 participants for Weeks 12 and 16. Wrinkle improvement was assessed on a 4-grade scale: Grade 1 (0-25%) = slight, Grade 2 (25-50%) = moderate, Grade 3 (50-75%) = marked, Grade 4 (\>75%) = significant. Data are presented as mean grades with standard deviation.
Visioscan measurements were taken at baseline, then at 8, 12, and 16 weeks by using a 4-grade percentage wrinkle improvement scale.
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 face
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Facial Skin Wrinkles
baseline
|
1 units on a scale
Standard Deviation 0
|
|
Facial Skin Wrinkles
8 wk
|
1 units on a scale
Standard Deviation 0
|
|
Facial Skin Wrinkles
12 wk
|
1 units on a scale
Standard Deviation 0
|
|
Facial Skin Wrinkles
16 wk
|
1 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The analysis population for this study on facial skin pigmentation utilizing Mexameter measurements comprised a total of 28 initially recruited subjects. These participants were assessed at four distinct time points: day 0 (baseline), 8 weeks, 12 weeks, and 16 weeks. One subject loss follow-up at week 12 and week 16.
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.
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 face
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Facial Melanin Index
Baseline
|
244.118 unitless index
Standard Deviation 10.186
|
|
Facial Melanin Index
8 weeks
|
246.296 unitless index
Standard Deviation 8.955
|
|
Facial Melanin Index
12 weeks
|
243.605 unitless index
Standard Deviation 10.074
|
|
Facial Melanin Index
16 weeks
|
240.660 unitless index
Standard Deviation 9.838
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: The analysis population included 28 subjects assessed at baseline, 8, 12, and 16 weeks. One participant was lost to follow-up after week 12.
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%).
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 Participants
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 1 : score 1
|
10 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 1 : score 2
|
18 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 1 : score 3
|
0 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 1 : score 4
|
0 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 2 : score 1
|
12 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 2 : score 2
|
16 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 2 : score 3
|
0 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
8 weeks Doctor 2 : score 4
|
0 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 1 : score 1
|
5 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 1 : score 2
|
20 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 1 : score 3
|
2 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 1 : score 4
|
0 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 2 : score 1
|
11 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 2 : score 2
|
14 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 2 : score 3
|
2 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
12 weeks Doctor 2 : score 4
|
0 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 1 : score 1
|
5 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 1 : score 2
|
12 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 1 : score 3
|
9 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 1 : score 4
|
1 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 2 : score 1
|
10 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 2 : score 2
|
12 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 2 : score 3
|
5 Participants
|
|
Overall Facial Skin Appearance (Photo Evaluation Using SGAIS)
16 weeks Doctor 2 : score 4
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: The assessment of participant satisfaction post-treatment involves all twenty-eight participants, with evaluations at 2, 3, and 4 months using a quartile grading system (0 = unsatisfied, 1 = slightly satisfied, 2 = satisfied, 3 = very satisfied). It is important to note that one subject was lost to follow-up since the 12-week mark.
Using a quartile grading system, (0 = unsatisfied), (1 = slightly satisfied), (2 = satisfied), and (3 = very satisfied)
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 Participants
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
8 weeks : very satisfied
|
10 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
8 weeks : satisfied
|
18 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
8 weeks : slightly satisfied
|
0 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
8 weeks : unsatisfied
|
0 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
8 weeks : NA (loss follow up)
|
0 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
12 weeks : very satisfied
|
5 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
12 weeks : satisfied
|
21 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
12 weeks : slightly satisfied
|
1 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
12 weeks : unsatisfied
|
0 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
12 weeks : NA (loss follow up)
|
1 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
16 weeks : very satisfied
|
6 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
16 weeks : satisfied
|
21 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
16 weeks : slightly satisfied
|
0 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
16 weeks : unsatisfied
|
0 Participants
|
|
Subject Satisfaction in Improving Skin Hydration, Elasticity, Wrinkles, and Pigmentation
16 weeks : NA (loss follow up)
|
1 Participants
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: The comprehensive evaluation encompassed a total of 28 subjects. One participant was lost to follow-up at the 12-week mark. Adverse events were systematically monitored through video calls at 2 and 4 weeks post-treatment initiation. On-site evaluations were conducted at 8, 12, and 16 weeks. At each time point, the number of participants analyzed was 28, with one participant lost to follow-up at the 12-week and 16-week evaluations.
Adverse events were systematically monitored at 2, 4, 8, 12, and 16 weeks post-treatment initiation.
Outcome measures
| Measure |
Epidermal Growth Factor Serum Application
n=28 Participants
Participants received Epidermal growth factor serum application on the face daily for two months compared to pre and post-results of skin quality.
Epidermal Growth Factor: Apply facial twice daily.
|
|---|---|
|
Adverse Events
12 weeks : Yes adverse event
|
0 Participants
|
|
Adverse Events
2 weeks : No adverse event
|
28 Participants
|
|
Adverse Events
2 weeks : Yes adverse event
|
0 Participants
|
|
Adverse Events
2 weeks : Data missing
|
0 Participants
|
|
Adverse Events
4 weeks : No adverse event
|
28 Participants
|
|
Adverse Events
4 weeks : Yes adverse event
|
0 Participants
|
|
Adverse Events
4 weeks :Data missing
|
0 Participants
|
|
Adverse Events
8 weeks : No adverse event
|
28 Participants
|
|
Adverse Events
8 weeks : Yes adverse event
|
0 Participants
|
|
Adverse Events
8 weeks : Data missing
|
0 Participants
|
|
Adverse Events
12 weeks : No adverse event
|
27 Participants
|
|
Adverse Events
12 weeks : Data missing
|
1 Participants
|
|
Adverse Events
16 weeks : No adverse event
|
27 Participants
|
|
Adverse Events
16 weeks : Yes adverse event
|
0 Participants
|
|
Adverse Events
16 weeks : Data missing
|
1 Participants
|
Adverse Events
Epidermal Growth Factor Serum Application
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Supawee Phanmamuang
Institute of Dermatology, Thailand
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place