Adolescents and young adults are particularly vulnerable to acne vulgaris, a chronic inflammatory condition of the pilosebaceous unit, which affects as much as 80-90% of this demographic. Comedones, papules, pustules, nodules, and cysts make up the range of lesions that characterize this condition, which mostly affects the back, chest, and face. Acne isn't always dangerous, but it can have serious mental consequences including low self-esteem, anxiety, and sadness, which can greatly affect one's quality of life [1-3].

Inflammation, hyperkeratinization of the follicles, colonization by the bacteria Cutibacterium acnes (formerly Propionibacterium acnes), and an increase in sebum production are all components of acne's complex pathophysiology. In addition to environmental triggers, hormonal effects, genetic predisposition, and nutritional factors all play a role in the severity of disease. Therefore, these fundamental mechanisms are the focus of management techniques [4, 5].

In cases with moderate to severe acne, the most effective treatment option is oral isotretinoin, a retinoid derivative of vitamin A. It reduces inflammation, normalizes follicular keratinization, and shrinks sebaceous glands and sebum production. The use of isotretinoin is restricted due to the possibility of adverse effects such as teratogenicity, hyperlipidemia, mucocutaneous dryness, hepatotoxicity, and long-term remission, which requires close monitoring [6].

Oral antibiotics like doxycycline and topical medicines like adapalene and benzoyl peroxide make up a common combo therapy. When used correctly, this method targets inflammatory responses and bacterial proliferation while also decreasing the likelihood of antibiotic resistance. While combination therapy does its job, it usually takes more time to see results and there's a chance of relapse if you stop taking it [7].

A comparative study is necessary to suggest the appropriate selection of treatment due to the variations in long-term results, safety profiles, and efficacy between oral isotretinoin and combination therapy. Thus, this study aimed to assess the oral isotretinoin and combination therapy for moderate to severe acne vulgaris in terms of clinical outcomes and side effects [8].

A randomized, comparative clinical study was conducted in the Department of Dermatology at a tertiary care center over a period of 12 months. This study was conduted at the Department of General Medicine, Kanyakumari Medical Mission Research Center, Muttom,Tamil Nadu, betwwen June 2023 to May 2024. A total of 60 patients clinically diagnosed with moderate to severe acne vulgaris were enrolled after obtaining written informed consent. Ethical approval was obtained from the Institutional Ethics Committee prior to the initiation of the study

Inclusion Criteria:

• Patients aged 16–35 years
• Clinically diagnosed with moderate to severe acne vulgaris
• Willing to participate and provide informed consent
• Patients not receiving any systemic acne treatment in the past 4 weeks

Exclusion Criteria:

• Patients with mild acne vulgaris
• Pregnant or lactating women
• Patients with a history of liver disease, hyperlipidemia, or other significant systemic illness
• Known hypersensitivity to isotretinoin, doxycycline, or topical retinoids
• Patients on concurrent medications that may interfere with study outcomes
• Patients unwilling to comply with follow-up schedule

A total of 60 patients with moderate to severe acne vulgaris were enrolled and completed the study. Patients were randomized into Group A (oral isotretinoin, n=30) and Group B (combination therapy, n=30). The results are summarized below.

Table 1: Baseline Demographic and Clinical Characteristics

Table 1 demonstrates that both groups were similarly distributed by age, gender, acne duration, and baseline GAGS scores (p > 0.05), suggesting that the randomization was adequate.

Table 2: Reduction in GAGS Score Over Time

Both groups' GAGS scores decreased significantly with time, as seen in Table 2. On the other hand, at 8 and 16 weeks, Group A (isotretinoin) demonstrated a noticeably larger drop than Group B.

                Table 3: Clinical Response (≥75% Reduction in GAGS Score)

According to Table 3, the effectiveness of isotretinoin was demonstrated by the considerably larger percentage of patients in Group A (80%) who achieved a 75% improvement compared to Group B (56.7%; p < 0.05).

Table 4: Percentage Reduction in GAGS Score

Isotretinoin was more clinically successful than Group B, as shown in Table 4, which shows that Group A showed a considerably bigger percentage reduction in acne severity.

Table 5: Adverse Effects Observed

Isotretinoin patients were more likely to have mucocutaneous side effects (cheilitis and dry skin), according to Table 5, whereas combination therapy patients were less likely to have these side effects and had different ones, including gastrointestinal problems and photosensitivity.

Patients quality of life can be greatly affected by acne vulgaris, a persistent inflammatory disorder of the pilosebaceous unit that frequently demands lengthy therapy. In order to better understand how oral isotretinoin and combination therapy handle moderate to severe acne vulgaris, this study compared the two [9].

According to the Global Acne Grading System (GAGS), both the oral isotretinoin group and the combination therapy group had a statistically significant improvement in the severity of acne. Nevertheless, at 8 and 16 weeks, the isotretinoin group showed a considerably larger decrease in GAGS score than the combination therapy group (p < 0.001), proving that isotretinoin was more effective [10].

We can say with confidence that the treatment methods, and not confounding factors, were responsible for the observed variations in outcomes in this study because both groups had similar baseline characteristics, including age, gender distribution, duration of acne, and starting GAGS scores [11, 12].

Compared to 56.7% in the group that received combination therapy, 80% of patients in the group that received isotretinoin showed a 75% improvement or more in this trial. The results of this study demonstrate that isotretinoin is more successful than other treatments in producing noticeable improvements in patient health. When compared to more traditional treatments, isotretinoin has shown to be the most effective option for severe acne, with longer periods of remission and lower rates of recurrence [13-15].

The current study found that the combination therapy group had a considerably lower mean percentage reduction in GAGS score (61.2 ± 11.1% vs. 78.3 ± 9.4%) compared to the isotretinoin group. Previous research has shown similar patterns, with isotretinoin showing a greater decrease in lesion count and severity. This is likely due to its multifactorial impact, which includes reducing sebum production, normalizing follicular keratinization, and fighting inflammation [16, 17].

The isotretinoin group had a higher incidence of side effects in this trial, with the most common being dry skin (60%) and cheilitis (70%). A small percentage of individuals (10%) experienced a slight increase in liver enzymes. The combined therapy group, on the other hand, had a lower incidence of side effects, including photosensitivity (16.7%) and gastrointestinal distress (20%). Systemic side effects of isotretinoin are often moderate and reversible with careful monitoring, although mucocutaneous dryness has consistently been recorded as the most common side effect in prior trials [18].

Both treatment approaches appear to be safe when administered by trained medical professionals, since no major side effects were recorded in either group in this investigation. Isotretinoin has more adverse effects than other drugs, so it's important to keep an eye on your liver function and lipid levels [19].

When compared to combination therapy, which mainly focuses on bacterial colonization and inflammation, isotretinoin's enhanced effectiveness is due to its action on the primary pathogenic causes of acne. If a patient has an adverse reaction to or is unable to utilize isotretinoin, combination therapy is still an option to consider [20].

There are certain caveats to be aware of, notwithstanding the study's merits. Due to the short follow-up period of only 16 weeks and the small sample size, the results may not be indicative of long-term effects or recurrence rates. Patients' adherence to topical treatment in the combo group may also have played a role in the findings [21, 22].,

Combination treatment and oral isotretinoin are both beneficial in managing moderate to severe acne vulgaris, according to the present study. Nevertheless, oral isotretinoin proved to be far more effective, with a higher percentage of patients seeing significant clinical improvement and a bigger decrease in acne severity. Although side effects were more common with isotretinoin, they were usually minor, predictable, and tolerable with close supervision. The safety profile of combination therapy was better, but its effectiveness was lower. People with moderate to severe acne vulgaris, especially those who need a quick fix and something that will last, might benefit from taking oral isotretinoin. Nevertheless, to guarantee safety, it is crucial to carefully choose patients, provide counseling, and regularly evaluate their progress. For individuals who experience side effects or are unable to utilize isotretinoin, combination therapy is still an option to consider.

Funding

None

Conflict of Interest:

None .

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