Introduction

After undergoing Nonablative fractional Fraxel laser (NAFL), a recognized treatment for skin rejuvenation, prompt post-procedural care is crucial to manage any possible complications and speed up the healing process.

Aim

To determine the efficacy and patient satisfaction of a topical serum  containing 15% vitamin C, 1% vitamin E, and 0.5% ferulic acid(CE Ferulic serum, CEF) following NAFL treatment.

Patient Profile

• Female patients with mild-to-moderate facial photodamage suitable for Fraxel laser treatment as determined by the investigator, exhibiting skin conditions including melasma, fine lines, enlarged pores, and dullness, etc.
• Fitzpatrick skin type II-IV
• Mean age of 31.6 years

Method

• Randomized, investigator-blinded, split-face, controlled trial.
• N=50
• All patients received Fraxel laser treatment on both sides of the face.
• After laser treatment, patients were randomly assigned to apply CEF on one side of the face and 0.9% normal saline on the other, using a random number table in a 1:1 ratio.
• Applications occurred immediately after the procedure and after daily morning skincare routines over a 7-day follow-up.
• Sunscreen was applied once daily,
• The study consisted of five visits, including the screening visit (T0: Days - -7 t 0), the enrollment & treatment visit (T1: Day 0, immediately post-procedure), & follow-up visits (T2-4: post- procedure Days 1, 3, & 7)

Study endpoint

• Primary endpoint
  • Change from baseline in erythema score (0 = no erythema, 1 = mild erythema, 2 = moderate erythema, 3 = severe erythema)  on Day 7
• Secondary endpoints
  • Change from baseline in erythema scores on Days 1 and 3
  • Changes in edema score and skin sebum content
  • Percentage changes in erythema index (EI), melanin index (MI), Skin hydration, transepidermal water loss (TEWL)
  • Scabbing formation/detachment
  • Patients' overall satisfaction assessed on Days 1, 3, and 7.
• Safety endpoints
  • Patient-reported pain level using a Visual Analogue Scale (VAS) from score 0 representing “no pain” to score 10 representing “extreme pain” at 15 min, 30 min, and 1 h immediately after the NAFL treatment and on Day 1.
  • Any adverse events (AEs) & serious adverse events (SAEs) were recorded.

Results

• On Day 7, a significant difference was noted in the change from baseline erythema score between the CEF side and the NS side (0.04 ± 0.40 vs. 0.18 ± 0.48, p = 0.011). (Table 1)
• Over the 7-day follow-up period, the erythema score remained lower on the CEF side compared to the NS side.

Table 1: Primary Endpoint Results

Erythema score; follow-up time	CEF, mean ± SD (n = 50)	NS, mean ± SD (n = 50)	Difference between groups, mean ± SD	p
T2-T0	1.18 ± 0.75	1.38 ± 0.78	−0.20 ± 0.49	0.008
T3-T0	0.58 ± 0.61	0.76 ± 0.62	−0.18 ± 0.44	0.008
T4-T0	0.04 ± 0.40	0.18 ± 0.48	−0.14 ± 0.35	0.011

Note: T0: baseline; T2: Day 1; T3: Day 3; T4: Day 7; T2–T0: the mean change from baseline on Day 1, T3–T0: the mean change from baseline on Day 3, T4–T0: the mean change from baseline on Day 7.

• EI and MI
  • The mean percentage change from baseline in EI was lower on the CEF side than on the NS side throughout the 7-day follow-up.
  • Notably, on Day 7, the CEF side demonstrated a significant improvement in the mean percentage change from baseline in EI compared to the NS side (-4.05% ± 22.12% vs. 5.72% ± 20.41%, p < 0.001).
  • The difference in percentage change  from baseline in MI was -7.16% ± 17.15% (p = 0.005) between the CEF side and the NS side on Day 3
• Skin Hydration, TEWL, and Skin Sebum Content
  • The percentage change in skin hydration from baseline was significantly higher on the CEF side compared to the NS side, with differences of 9.53% ± 24.37% on Day 1 and 11.80% ± 24.94% on Day 3.
  • Although the CEF side exhibited a lower percentage increase in TEWL over the 7-day follow-up, no significant differences were found.
  • Both CEF side & the NS side showed no differences in change in skin sebum content

Table 2: Secondary Endpoints

Parameters; follow ­up time	Mean percentage changes from baseline ± SD		Difference between groups, mean ± SD	p
	CEF (N = 50)	NS (N = 50)
Erythema index (EI)
T2: Day 1	7.57 ± 25.25	23.66 ± 21.37	−16.09 ± 22.66	< 0.001
T3: Day 3	10.50 ± 22.86	20.86 ± 27.25	−10.36 ± 28.61	0.084
T4: Day 7	−4.05 ± 22.12	5.72 ± 20.41	−9.77 ± 17.11	< 0.001
Melanin index (MI)
T2: Day 1	1.46 ± 13.58	−1.87 ± 13.71	3.33 ± 18.29	0.204
T3: Day 3	3.35 ± 17.46	10.50 ± 17.17	−7.16 ± 17.15	0.005
T4: Day 7	0.95 ± 14.77	2.40 ± 13.30	−1.45 ± 16.38	0.534
Skin hydration
T2: Day 1	−1.61 ± 32.26	−11.14 ± 21.17	9.53 ± 24.37	0.007
T3: Day 3	−6.64 ± 25.93	−18.44 ± 27.44	11.80 ± 24.94	0.002
T4: Day 7	2.94 ± 19.00	−0.38 ± 17.42	3.32 ± 16.22	0.154
Transepidermal water loss (TEWL)
T2: Day 1	68.15 ± 91.87	86.97 ± 97.56	−18.83 ± 66.20	0.050
T3: Day 3	19.50 ± 64.07	26.84 ± 59.77	−7.34 ± 56.14	0.360
T4: Day 7	20.34 ± 53.90	26.46 ± 54.45	−6.12 ± 49.37	0.385
Skin sebum contenta
T2: Day 1	15.46 ± 39.81	11.46 ± 26.23	4.00 ± 36.72	0.782
T3: Day 3	1.64 ± 16.38	2.22 ± 18.41	−0.58 ± 10.43	0.456
T4: Day 7	−1.58 ± 13.77	−0.62 ± 15.77	−0.96 ± 13.50	0.600

Abbreviations: CEF, CE Ferulic serum; NS, normal saline; SD, standard deviation.

^aSkin sebum content was the mean changes from baseline, while the other parameters were the mean percentage changes from baseline; T2: Day 1; T3: Day 3; T4: Day 7.

• Skin Edema and Scabbing Detachment Stage
  • The edema score showed a trend of reduction throughout the follow-up period, while no significant differences were noted in the scabbing detachment stage between the CEF side and the NS side during the follow-up.
• Patient Overall satisfaction
  • On Day 7, patients expressed greater satisfaction with the CEF side compared to the NS side across various skin quality attributes, including unevenness, aging, enlarged pores, scarring, smoothness, and radiance.
  • A higher percentage of patients reported being very satisfied with the efficacy (59.2% for CEF vs. 46.9% for NS) & comfort (53.1% for CEF vs. 38.8% for NS) of the CEF side.
  • 49% felt that the results from the CEF side exceeded their expectations, with no patients rating it below expectations, while 4.1% indicated that the NS side did not meet their expectations.

Safety

• Patients reported significantly lower pain levels on the CEF side compared to the NS side at both 30 minutes and 1 hour after NAFL treatment, with no adverse events related to the product noted.

Conclusion

The study revealed that applying CEF serum post-procedure significantly enhanced/promoted the healing process compared to NS. The results highlight the advantages of using CE Ferulic after Fraxel laser treatment, including reduced erythema, improved skin hydration, and better overall treatment outcomes.

Reference

Journal of Cosmetic Dermatology, 2025; 24:e70251