Articles Vol. 67 No. 9 25/09/2026

EFFICACY AND SAFETY OF TOPICAL LAHA ACNE SOLUTION COMBINED WITH ORAL ISOTRETINOIN FOR MODERATE ACNE VULGARIS: A RANDOMIZED CONTROLLED TRIAL

La Thanh Ha
DOI: 10.52163/yhc.v67i9.6644
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Abstract

Objective: To evaluate the efficacy and safety of Laha acne topical solution combined with oral isotretinoin in the treatment of moderate acne vulgaris.

Subjects and methods: A two-phase study: a preclinical skin-irritation phase in 3 male New Zealand White rabbits, followed by a randomized controlled clinical trial in 70 patients with moderate acne vulgaris (35 per group). The study group received Laha acne solution twice daily plus oral isotretinoin (0.3–0.5 mg/kg/day); the control group received 4% erythromycin gel twice daily plus the same isotretinoin regimen, for 2 months.

Results: The solution caused only very slight erythema (irritation index 0.33, negligible). At month 2, excellent/good response rates were 25.7%/73.3% in the study group versus 2.9%/62.9% in the control group; no study-group patient had only moderate response versus 34.3% in controls (p < 0.05). Very-satisfied rates were 62.8% vs 31.5% (p < 0.05).

Conclusion: Topical Laha acne combined with oral isotretinoin was more effective than 4% erythromycin gel combined with isotretinoin, with good local tolerability and low irritation potential.

Keywords
acne vulgaris, isotretinoin, erythromycin gel, topical solution, Laha acne
References
[1]
1. Zhu Z, Zhong X, Luo Z, Liu M, Zhang H, Zheng H, Li J. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10–24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025;192(2):228–237. doi:10.1093/bjd/ljae352 Google Scholar
[2]
2. Eichenfield DZ, Sprague J, Eichenfield LF. Management of acne vulgaris: a review. JAMA. 2021;326(20):2055–2067. doi:10.1001/jama.2021.17633 Google Scholar
[3]
3. Fallah H, Rademaker M. Isotretinoin in the management of acne vulgaris: practical prescribing. Int J Dermatol. 2021;60(4):451–460. doi:10.1111/ijd.15089 Google Scholar
[4]
4. Đỗ Thị Mùi. Đánh giá tác dụng bột đắp Kim ngân hoa trong điều trị trứng cá thông thường [Luận văn Thạc sĩ]. Học viện Y Dược học cổ truyền Việt Nam; 2016. Google Scholar
[5]
5. Phan Thị Hoa. Nghiên cứu độc tính và hiệu quả của dịch chiết từ rễ cây Ba Bét Lùn (Mallotus nanus Airy Shaw) điều trị bệnh trứng cá thông thường [Luận án Tiến sĩ Y học cổ truyền]. Đại học Y Hà Nội; 2016. Google Scholar
[6]
6. Orafidiya LO, Agbani EO, Oyedele AO, et al. The effect of Aloe vera gel on the anti-acne properties of the essential oil of Ocimum gratissimum Linn leaf: a preliminary clinical investigation. Int J Aromatherapy. 2004;14(1):15–21. Google Scholar
[7]
7. OECD. Test No. 404: Acute Dermal Irritation/Corrosion. OECD Guidelines for the Testing of Chemicals, Section 4. Paris: OECD Publishing; 2015. Google Scholar
[8]
8. ICH. M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. International Council for Harmonisation; 2009. Google Scholar
[9]
9. McCoy K. Acne and related disorders. Merck Manual; 2008. Available from: www.merckmanuals.com Google Scholar
[10]
10. Beig M, Shirazi O, Ebrahimi E, Zare Banadkouki A, Golab N, Sholeh M. Prevalence of antibiotic-resistant Cutibacterium acnes (formerly Propionibacterium acnes) isolates, a systematic review and meta-analysis. J Glob Antimicrob Resist. 2024;39:82–91. Google Scholar