A Randomized Controlled Trial on the Effectiveness of Epidermal Growth Factor-Containing Ointment on the Treatment of Solar Lentigines as Adjuvant Therapy

Hye One Kim, Hye Ran Kim, Jin Cheol Kim, Seok Young Kang, Min Je Jung, Sung Eun Chang, Chun Wook Park, Bo Young Chung, Hye One Kim, Hye Ran Kim, Jin Cheol Kim, Seok Young Kang, Min Je Jung, Sung Eun Chang, Chun Wook Park, Bo Young Chung

Abstract

Background and Objective: Little is known about the anti-pigmentation effects of whitening agents on solar lentigines. Epidermal growth factor (EGF) has been used as a booster for wound healing in the skin, and it has been suggested to have anti-pigmentation effects. This study aimed to evaluate the effect and safety of EGF-containing ointment for treating solar lentigines with a Q-switched (QS) 532 nm neodymium-doped yttrium aluminum garnet (Nd:YAG) laser (Bluecore company, Seoul, Republic of Korea). Materials and Methods: Subjects who underwent QS 532 nm Nd:YAG laser treatment of solar lentigines were randomly assigned to treatment with an EGF ointment or petrolatum. After the laser procedure, the subjects were administered the test ointment twice a day for 4 weeks. The physician's assessment of the degree of pigment clearance and patient's satisfaction were assessed after 4 and 8 weeks. Additionally, the melanin index (MI), erythema index (EI), transepidermal water loss (TEWL), and post-inflammatory hyperpigmentation (PIH) were evaluated. This trial was registered with ClinicalTrials.gov (NCT04704245). Results: The blinded physician's assessment using 5-grade percentage improvement scale and patient's satisfaction were significantly higher in the study group than in the control group at the 4th and 8th weeks. The MI was significantly higher in the control group than in the study group at the 4th and 8th weeks. The EI and TEWL did not differ significantly between the two groups at either time point. The incidence of PIH was higher in the control group (37.5%) than in the EGF group (7.14%) at the 8th week. Conclusions: The application of EGF-containing ointment on facial solar lentigines with a QS 532 nm Nd:YAG laser showed efficient and safe therapeutic effects, with less PIH. Thus, EGF-containing ointment could be suggested as the promising adjuvant treatment strategy with a QS laser for solar lentigines.

Keywords: Q-switched 532 nm Nd:YAG laser; epidermal growth factor; pigmentary disorder; post-inflammatory hyperpigmentation.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of the study participant inclusion. A total of 40 subjects (20 in the study group and 20 in the control group) were enrolled in this study, and 30 (14 in the study group and 16 in the control group) completed all clinical evaluations (excluding those who were lost to follow-up).
Figure 2
Figure 2
(A) Assessment of the 5-grade scale for improvement by a physician at 4 weeks. (B) Assessment of the 5-grade scale for improvement by a physician at 8 weeks.
Figure 3
Figure 3
Clinical photographs of the patients in the study group (grade 5 improvement). (A) Before treatment in the study group. (B) At 8 weeks in the study group. Red circles; treated areas.
Figure 4
Figure 4
Clinical photographs of the patients in the control group (grade 2 improvement). (A) Before treatment in the control group. (B) At 8 weeks in the control group. Red circles; treated areas.
Figure 5
Figure 5
(A) Melanin index (MI) at baseline and follow-up observation. At weeks 4 and 8, the control group showed significantly higher MI than the study group. * p < 0.05 compared with the control group. (B) Erythema index (EI) at baseline and follow-up observation. The EI measured at week 8 showed no significant difference between the groups (p = 0.968). Both the study group (p = 0.941) and control group (p = 0.405) showed no significant difference between the baseline and 8-week EI values. (C) Transepidermal water loss (TEWL) at baseline and follow-up observation. For TEWL, there was no significant difference between the study and control groups at the last visit (p = 0.862). Both the study group (p = 0.911) and control group (p = 0.577) showed no significant difference between the baseline and 8-week TEWL values.

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