Moringa oleifera Seed Oil vs 2.5% Benzoyl Peroxide Gel in the Treatment of Acne Vulgaris

Introduction

Acne vulgaris affects the pilosebaceous unit, resulting in non-inflammatory lesions such as open & closed comedones and inflammatory lesions that leave scars, for example, papules, pustules, as well as nodules.¹ Acne attacks the skin with dense sebaceous follicles, such as the skin on the face, chest, and the back.²

 The main pathogenic factors include elevated and modified sebum produced by sebaceous glands, changes in the process of follicular keratinization resulting in comedone formation, and the invasion of follicles by Propionibacterium acnes, which triggers innate immunity activation and increases inflammation. Though acne is not a fatal condition, numerous studies have shown that it impairs adults' and adolescents’ quality of life.^3,4

Depending on the severity of acne, treatment may include oral or topical retinoids, antibiotics, or benzoyl peroxide. The cost of treating acne may be high and feasibility in the affected population is questionable. In this regard, Moringa oleifera seed oil could serve as a cost-effective alternative for treating acne. The genus Moringa has been utilized extensively in health promotion.

The genus has also traditionally been used to treat sore throat, fever, diarrhoea, wounds, anxiety, asthma, and skin infections. The plant posse- sses antioxidant, anti-inflammatory, anti-cancer, anti microbial, and antidiabetic properties.⁵

All parts of the Moringa plant have medicinal uses. Its seeds are used to purify water, leaves can be used for nutritional benefits, oil is used as biofuel, trunk can be used as gum, and flowers are used as honey.⁵

According to various studies, M. oleifera is widely recognized as the "Miracle tree" and "Mother's best friend". It is also well known as a plant rich in nutrients.⁵

Benzoyl peroxide exhibits antiseptic activity and keratolytic effects, and the emergence of drug-resistant bacteria is not a concern.⁶ Benzoyl peroxide is approved for treating both inflammatory & non-inflammatory acne vulgaris and to control the recurrence of inflammation after it subsides.⁶

Worldwide, many nations have used topical benzoyl peroxide (BPO) for the treatment of acne vulgaris. The use of antibiotics is one of the primary methods for treating acne vulgaris. However, prolonged use of antibiotics has raised concerns about the emergence of resistance to antibiotics.

Adults, as well as adolescent males and females, are known to develop acne vulgaris. Although acne is not a life-threatening disorder, it can impact the appearance of an individual, potentially leading to emotional distress and a lower quality of life in both adults and adolescents. As a result, there is an increased need for an effective acne treatment. Despite the growing interest in acne treatment with M. oleifera extract, significant gaps remain in the existing body of knowledge. Furthermore, little is known about the potential of Moringa extract in combination with other acne therapies. This study aimed to compare the therapeutic effectiveness and safety of 2.5% benzoyl peroxide and M. oleifera seed oil in the treatment of mild to moderate acne.

Aims and Objectives

To compare the efficacy of M. oleifera seed oil extract with that of 2.5% benzoyl peroxide in treating mild to moderate acne vulgaris.

Materials and Methods

The current research was a prospective, open-labelled, randomized, active-controlled study conducted between April 2023 and September 2023, after obtaining approval from the Institutional Ethical Committee (GIMS/KLB/PHARMA/IEC/213/2023-2024 dated 22 08-2023). Written informed consent was procured from all the study participants before initiating the study. The investigation was conducted in the Department of Dermatology at Gulbarga Institute of Medical Sciences Hospital, Kalaburagi, Karnataka, India. Outpatients from the Department of Dermatology visiting the hospital between April 2023 and September 2023 for acne vulgaris treatment were selected as study participants.

To determine their eligibility for participation, each participant underwent a comprehensive general physical and systemic examination.

Participants received treatment with either the test drug, M. oleifera seed oil (obtained from a standard pharmacy with a quality certificate) or the active control, a commercially available conventional 2.5% benzoyl peroxide gel. The participants included in the study were healthy volunteers of both genders, aged between 12 to 40 years, attending the dermatology outpatient with mild to moderate acne as per Physician’s Global Assessment (PGA) of acne, with good general health without any comorbidities. All the participants willing to follow instructions such as to avoid excessive exposure to sunlight and any light treatments, any professional or aesthetic spa-like procedures, were included in the study.

Participants were excluded from the research if they had allergies or sensitivity to the product ingredients or light, severe acne, a pre-existing dermatological facial condition, an uncontrolled disease or immune deficient disorder, or if they were pregnant, intended to become pregnant, or were breastfeeding.

Participants who were on prescribed medications for acne treatment or had undergone antibiotics treatment within six months prior to the research initiation were excluded.

In the current research, a total of 60 participants were screened for inclusion and exclusion criteria. All the 60 subjects provided written informed consent following which they were allocated to two treatment groups - 30 subjects to Group A and 30 subjects to Group B. The Group A consisting of 11 male and 19 female healthy volunteers received M. oleifera seed oil extract and the Group B consisting of three male and 27 female healthy volunteers received 2.5% benzoyl peroxide gel. All the participants were instructed to clean and dry their faces prior to the application of the medication on the face. Participants in Group A were advised to apply a thin film of M. oleifera seed oil on the entire face at night and massage it. The participants in Group B were told to apply the gel in a thin layer over the afflicted area of their face before going to bed. All participants were instructed to apply their respective medications daily on their face as directed for eight weeks.

Each participant was monitored for eight weeks following the start of therapy. The follow-up outpatient visits were scheduled at weeks 2, 4, 6, and 8. By calculating the entire number of inflammatory as well as non-inflammatory lesions at baseline (day 0), during the second, fourth, sixth, and eighth weeks of therapy, the efficacy was determined. The percentage reduction in total lesions from baseline (day 0) to the end of the treatment was calculated. Acne severity was assessed using the Physician’s Global Assessment (PGA) scale for acne (Table 1). During the follow-up, any adverse events were documented with date of onset and severity (mild, moderate, or severe) and assessed using the Global assessment of tolerability scale. A total number of 60 patients met the enrolment criteria, completed follow-up, and regularly used the study medications, making them eligible for final analysis.

Statistical analysis was carried out using SPSS software version 20. Continuous variables were depicted as mean±standard deviation (SD). The paired t-test was used to compare the variations seen within groups from baseline to follow-up visits. An independent t-test was used to compare the mean variations between the two groups. A P-value of less than 0.05 was considered statistically significant.

 Results

Sixty subjects with mild to moderate acne vulgaris successfully completed the 8-week follow-up.

The grading for response to treatment in this study is defined as follows:

Grade 1: Poor response (<30% reduction in lesions).

Grade 2: Fair response (30-60% reduction in lesions).

Grade 3: Good response (60-90% reduction in lesions).

Grade 4: Excellent response (>90% reduction in lesions).

Among the 30 patients included in Group A who received M. oleifera seed oil extract for mild to mod erate acne vulgaris, it was observed that the mean re sponse of comedones to treatment with oil extract of M. oleifera seeds was as follows: 2.86 at the end of 2nd week, 2.97 at the end of the fourth week, 2.77 after the 6th week, and 2.73 after the eighth week (Figure 1). As shown in Figure 2, the mean response of papules to treatment with M. oleifera seed oil extract was 3.20 at the end of the second week, 3.40 after the fourth week, 3.30 after the sixth week, and 3.30 at end of the 8th week. The mean response of pustules to treatment with M. oleifera seed oil extract was 3.43 after the second week, 3.37 at the end of the fourth week, 3.47 after the sixth week, and 3.50 after the eighth week (Figure 3).

Among the 30 patients included in Group B who were treated with 2.5% benzoyl peroxide for mild to moderate acne vulgaris, it was observed that the mean response of comedones to treatment at the end of the second week was 3.10, after the 4th week was 3.20, after the 6th week was 3.40, and by the conclusion of the eighth week was 3.67 (Figure 1). The mean response of papules to 2.5% benzoyl peroxide treatment by the conclusion of the sec ond week was 2.87, by the conclusion of the fourth week was 2.87, by the conclusion of the eighth week was 3.17, and at the end of 8th week was 3.30 (Figure 2). The mean response of pustules to 2.5% benzoyl peroxide treatment after the second week was 3.10, by the end of the fourth week was 3.30, after the 6th week was 3.50, and by the conclusion of 8th week was 3.80 (Figure 3).

During the study period, a notable distinction was ob served between the two treatment agents. The mean re sponse, based on grading, showed that treatment with 2.5% benzoyl peroxide resulted in a greater reduction of comedones, papules, and pustules compared to treat ment with M. oleifera seed oil extract. This indicates that treatment with 2.5 percent benzoyl peroxide was more effective in reducing comedones, papules, pus tules in individuals with mild to moderate acne vulgaris (Figure 1, 2, 3).

The total number of inflammatory and non-inflammatory lesions present at baseline was assessed and compared at  the conclusion of second, fourth, sixth and eighth weeks. Following an 8 week treatment period, the results revealed differences in the reduction of total lesions between the M. oleifera seed oil extract treatment and the 2.5% benzoyl peroxide treatment. For come- dones, by the conclusion of 2nd week, P = 0.149; after the 4thweek, P = 0.163; by the conclusion of the 6thweek, P = 0.001; at the end of the eighth week, P <0.001. For papules, after the 2nd week, P = 0.053; by the conclusion of 4thweek, P = 0.012; after the 6thweek, P = 0.529; by the conclusion of 8th week, P < 1. For pustules, at the end of second week, P = 0.126, by conclusion of the 4th week, P = 0.708; after the 6thweek, P = 0.845; by the conclusion of 8thweek, P <0.043 (Table 2).

The overall number of lesions, when compared between baseline and the end of the eighth week of treatment with M. oleifera seed oil extract, showed a P value of 0.967. In contrast, the total lesion count, when compared between baseline and the end of the 8th week of treatment with 2.5% benzoyl peroxide cream, showed a P value of <0.001 (Table 2).

Discussion

The current investigation was conducted to evaluate the effectiveness of the oil extract of Moringa oleifera seeds in comparison to 2.5 percent benzoyl peroxide in the treatment of mild to moderate acne vulgaris. During the treatment, a significant reduction in comedones, papules, and pustules was observed with 2.5% benzoyl peroxide treatment, indicating its superiority over Moringa oleifera seed oil extract in reducing the lesions of acne vulgaris.

In a controlled, randomized, non-superiority, open-label trial conducted by Abdurajak et al., 31 male students from Boniao National High School were included.7 Two groups of participants were created: the benzoyl peroxide group (n=17) and the Moringa oleifera group (n=14). The total lesion count (TLC) score on days 15, 30, and 45 was compared with the baseline. Treatment failure rates and side effects were reported. Following a 45-day treatment period, the results revealed distinct differences in the reduction of the mean TLC scores in the Moringa oleifera group (P =0.003) and the benzoyl peroxide group (P =0.003). Desquamation was the only negative impact reported in the Moringa oleifera group (8 out of 14), while pruritus was reported in the benzoyl peroxide group (2 out of 17). No treatment failure was noted in either group. There was a notable distinc tion between the two groups in terms of reducing the TLC scores. The study stated that M. oleifera is similar to benzoyl peroxide and is also an effective anti-acne treatment. It was recommended that high school students with acne vulgaris can receive the M. oleifera topical gel as an alternative to benzoyl peroxide.⁷

Bassett IB et al., conducted a single-blind, randomized clinical research involving 124 patients to test the skin tolerability and efficacy of 5% tea-tree oil gel v/s 5 per cent benzoyl peroxide lotion as a treatment for mild to moderate acne.8 Although the oil of tea-tree took longer to show effects, the study's findings demonstrated that both 5% tea-tree oil gel and 5% benzoyl peroxide sig nificantly reduced the number of non-inflammatory as well as inflammatory lesions (open & closed comedo nes) in patients with acne.⁸

Burke B et al., conducted a double-blind clinical trial including 94 participants. It was observed that 1.5 per cent (w/v) erythromycin lotion was as efficient as 5 per cent (w/v) benzoyl peroxide gel in lowering the number of tiny inflammatory lesions and the overall severity of acne. Nevertheless, erythromycin had little effect on non-inflammatory lesions, while benzoyl peroxide markedly decreased their quantity.⁹

In the present study on mild to moderate stage acne vulgaris, treatment with Moringa oleifera seed oil ex tract showed a poor mean response in reducing come dones by the end of the eighth week compared to base line. In contrast, treatment with 2.5% benzoyl peroxide demonstrated significant improvement in comedone re duction over the same period (Figure 1).

By the end of the 8th week, the mean response to treat ment with M. oleifera seed oil extract on papules, when contrasted to baseline, showed no improvement and even worsened. In contrast, treatment with 2.5% ben- zoyl peroxide resulted in significant improvement in papule reduction over the same period (Figure 2).

By the end of the eighth week, the mean response to M. oleifera seed oil extract treatment on pustules, compared to baseline, deteriorated. In contrast, treat ment with 2.5% benzoyl peroxide showed improvement in pustule reduction over the same period (Figure 3).

When comparing total lesion count between baseline and the 8th week of treatment, Moringa oleifera seed oil extract showed a P value of 0.967, indicating no  significant improvement. In contrast, treatment with 2.5% benzoyl peroxide resulted in a P value of <0.001, demonstrating a statistically significant decrease in le sion count (Table 2). Hence, a significant difference was observed in the reduction of the total lesion count, with 2.5 percent benzoyl peroxide, demonstrating greater effectiveness compared to M. oleifera seed oil extract in treatment of mild to moderate acne vulgaris.

In a double-blind clinical study conducted by Burke B et al., 5% benzoyl peroxide gel was effective in reducing the number of small, inflamed lesions and the overall acne severity in 94 subjects as compared to 1.5 percent erythromycin lotion. These findings align with that of the present study where improvement in comedones, papules and pustules was observed on treatment with 2.5 percent benzoyl peroxide.⁹

In the current study, five study participants reported side effects such as dryness and skin irritation after using benzoyl peroxide, which improved on using an oil free moisturizer. On using M. oleifera seed oil extract, four study participants reported erythema and skin irritation. These adverse effects were mild, comparable between both the groups and no patients withdrew from the study due to them.

This study adds to the growing body of evidence investigating natural alternatives to conventional acne treatments. Most of the studies conducted to date are limited by small sample size and a lack of diverse populations. Additionally, while benzoyl peroxide’s mechanisms of action are well-documented, the precise pathways through which M. oleifera exerts its effects on acne are not fully understood. Also, the absence of direct, large-scale comparative studies evaluating the effica cy and safety of M. oleifera extract against standard ized concentrations of benzoyl peroxide, such as 2.5%, highlights the need for further research. Long-term safety data on Moringa extract are scarce and the variability in preparation methods complicates the standardization of dosages. Furthermore, little is known about the potential of Moringa extract in combination with other acne therapies, or its side effect profile in prolonged usage. Hence further research would be required to address these gaps which in turn will be crucial for translating its use into clinical practice and optimizing its role in acne treatment.

The strengths of the study are, first, that it pro vides meaningful insights into the potential use of M. oleifera seed extract versus 2.5% benzoyl peroxide, in the treatment of mild to moderate acne vulgaris. Secondly, as there are not many studies available on alternative natural, plant-based treatment such as M. oleifera seed extract, this study contributes valuable preliminary data that can guide future research and clinical applications.

Limitations of this study include the small sample size and short duration. Studies involving a larger population and extended follow-up periods are needed to generate more robust scientific evidence regarding the efficacy and safety of M. oleifera seed oil and 2.5% benzoyl per oxide.

Conclusion

From this present research, it can be concluded that 2.5 percent benzoyl peroxide gel was more efficacious than Moringa oleifera seed oil extract treatment in decreasing the total number of non-inflammatory as well as inflammatory lesions in mild to moderate cases of acne vulgaris, thereby contributing to a more comprehensive understanding of alternative treatments for acne management. M. oleifera seed oil does not significantly reduce the inflammatory & non-inflamma tory lesions in mild to moderate cases of acne vulgaris.

Conflicts of Interest

None