The clinical efficacy of a new emulsion for acne and conspicuous facial pore amelioration

Oily skin is a common concern in the field of dermatology due to its association with excessive sebum production, acne, blackheads, and enlarged facial pores. Therefore, it is in great demand to develop effective cosmetics to manage oily skin.

the capability to reduce sebum secretion, stimulate collagen type I expression, reinforce pore structure, and restore normal keratinization. 13However, most current treatment approaches often rely on isolated sebum blockage or exfoliating, showing limited efficacy in managing oily skin. 14A more effective strategy necessities the combination of various functional ingredients that target multiple factors for oily skin management.
In this study, niacinamide, white willow bark extract and lens esculenta seed extract were combined and formulated in a novel emulsion for the management of oily skin and its associated symptoms.Clinical data from instrument evaluation, professional dermatologist evaluation, and subjects' self-assessment all proved the efficacy of the product in improving acne, blackheads, and conspicuous facial pores.

| Emulsion formula
The tested active emulsion and control base emulsion were provided by Mageline Biology Tech Co., Ltd.Ingredients of the control base emulsion and the active emulsion were listed in Table 1.

| In vivo clinical trial
The in vivo clinical study was carried out at the SGS Shanghai test center in Shanghai.The research protocol for this study (SHCPCH200403526) underwent evaluation and approval by the SGS Ethics Committee for Clinical Research.The possible benefits, risks, and complications were thoroughly explained to the subjects.
All participants enrolled in this study received a written informed consent.

| Subjects and study protocol
Thirty healthy male subjects (average age: 29 ± 6.4 years) meeting the specified criteria were recruited for this study.Inclusion criteria included: (1) oily skin or combination skin, with skin oil content >120 μg/cm 2 on the cheek and forehead areas; (2) presence of at least five blackheads on the nose tip; (3) visible facial pores graded ≥1 (according to the Asian Skin Aging Atlas, Volume 2); 15 (4) presence of >5 inflammatory acne lesions on the facial skin (with at least one easily marked inflammatory acne); (5) >10 non-inflammatory acne lesions on the facial skin; (6) facial inflammatory acne grade ≥2 according to the Investigator Global Assessment of Acne (IGA); 16  (7)   nodules on the face with a maximum diameter <5 mm; (8) absence of noticeable redness, skin lesions, and facial scars.
Throughout the experimental period, all participants were instructed to apply the active emulsion to one side of their face and control base emulsion to the other side twice daily (morning and evening) for 56 consecutive days.

| Photography
Prior to VISIA and PRIMOS measurements, participants were instructed to acclimate within the measurement room for 30 min.The room was maintained at a temperature of 21 ± 1°C and a relative humidity of 50% ± 5% RH to minimize the influence of environmental influences.The VISIA-CR system (Canfield Scientific Inc, Fairfield, NJ, USA) was employed for facial image acquisition and apex nasi blackhead analysis.The PRIMOS CR system (Canfield Scientific, Parsippany, New Jersey) was utilized for capturing facial pictures within specific areas of interest, with subsequent analysis of acne lesions conducted through PRIMOS software (Canfield).Standardized images of the participants' facial skin surface were obtained by the VISIA image system (Canfield Scientific, Parsippany, NJ, USA) according to previous studies. 17,18The pore-related parameters (i.e., facial pore count, pore size, and pore area) were analyzed using the VISIA software.

| Clinical evaluation of dermatologists
Clinical dermatologists carried out a comprehensive visual and sensory evaluation of the active emulsion's efficacy based on the subjects' facial condition.This evaluation encompassed factors such as blackheads, pimples, papules, and inflammatory acne grade.The assessments were performed both at the beginning and after a 56-day treatment period using the active emulsion.

| Subject self-assessment
Subjects completed self-assessment questionnaires concerning the emulsion performance, both at baseline and after using the emulsion for 14, 28, and 56 days.

The control base emulsion
The active emulsion

| Statistical analysis
SPSS software version 19.0 (SPSS Inc.) was utilized for the statistical analysis.The data were expressed as mean ± SD or SEM.Two-tailed t-tests were performed, and the statistical differences were considered significant at a p < 0.05.

| Improvement of acne condition
VISIA was used to measure the reduction of facial acne on human subject before and after daily application of the active emulsion for different duration.Figure 1 shows a significant decrease of blackheads and acne on the nasal tip region after 14 days of active emulsion use.Continued application of the active emulsion for 28 and 56 days led to further reductions of 3.12% and 6.90%, respectively.
The representative VISIA image was shown in Figure 2, demonstrating the active emulsion's effectiveness in ameliorating facial acne.
The 3D microtopography of the acne area was also imaged and analyzed.Figure 3A shows the original acne volume and its analysis diagram by PRIMOS.Following 28 days of active emulsion application, the acne flattened and significantly reduced in size.After 56 days of active emulsion application, the acne almost disappeared.

| Clinical evaluation of dermatologists
The clinical efficacy of the active emulsion was further evaluated by dermatologists, as summarized in Table 2.It could be found that after using the active emulsion for 14, 28, and 56 days, the number of blackheads and pimples was significantly reduced by 55.13%, 77.0%, and 99.10%, respectively.Additionally, twice-daily application over 56 days significantly reduced papule count by 93.79% and inflammatory acne grade by 30.16%.

| Self-assessment questionnaires
Subject questionnaire results showed that ~90% of participants were satisfied with the 56-day efficacy of the active emulsion (Figure 5).
Approximately 83% of participants reported substantial reduction in skin oil secretion after 56 days of active emulsion use.A majority of the participants observed significant improvement in acne, facial pores, and blackheads following active emulsion application.F I G U R E 5 Bar graph depicting the percentage of subjects reporting positively to the self-assessment questions at different time points.
After 18 days of active emulsion use, participants' facial pores significantly improved.As shown in Figure4A, the pore number rate and F I G U R E 1 Decrease rate of average area ratio of blackhead and acne (%) after daily application of the active emulsion for 14, 28, and 56 days.Results were presented as mean ± SEM, n = 30 (*p < 0.05; **p < 0.01; ***p < 0.001 compared with the baseline).FI G U R E 2 Representative VISIA images showing the reduction of facial acne on human subject before and after daily application of the active emulsion for 14, 28, and 56 days.The left side indicates the control group and the right side indicates the active application group.the proportion of average pore area decreased by 1.73% (p < 0.05) and 6.87% (p < 0.001) after use of the active emulsion for 56 days.

Figure
Figure 4B displays representative facial surface replicas captured by VISIA before and after 14, 28, and 56 days of active emulsion treatment, clearly showing a significant reduction in facial pore count.

F I G U R E 3
(A) Representative original acne volume and analysis diagram by PRIMOS after 14, 28, and 56 days of active emulsion treatment.(B) Reduction of the acne volume after 14, 28, and 56 days of active emulsion treatment.Results were presented as mean ± SEM, n = 30 (***p < 0.001 compared with the baseline).F I G U R E 4 (A) Decrease rate of pore number and pore area ratio after daily application of the active emulsion.Results were presented as mean ± SEM, n = 30 (*p < 0.05; **p < 0.01; ***p < 0.001 compared with the baseline).(B) Representative VISIA images showing the reduction of conspicuous facial pores on human subject.TA B L E 2 Summary of the clinical evaluation results from dermatologists.