Title: Efficacy and Safety Profile of Spironolactone 50mg v/s Isotretinoin 10mg in the Treatment of Female Patients with Acne Vulgaris Grade 1-2 - A Double Blinded, Randomized Comparative Study
Authors: Natasha Vijayendran, Mohan Kale, Varsha Jamale, Balkrishna Nikam, Asma Hussain, Shraddha J. Patil
DOI: https://dx.doi.org/10.18535/jmscr/v6i2.25
Abstract
Background: The recognition that post-adolescent women with AV respond to antiandrogenic hormonal therapies has prompted a sustained interest in oral spironolactone. We took this as an opportunity to determine the safety and efficacy of two treatment modalities for acne vulgaris grade 1-2 and provide standardized data regarding spironolactone as a treatment agent in acne vulgaris. This is the first double blinded study where low dose spironolactone and low dose isotretinoin has been studied.
Aims: To study the efficacy and safety profile of oral spironolactone v/s oral isotretinoin in the treatment of female patients with acne vulgaris grade 1-2.
Materials and Method: 60 patients were enrolled in the study. Thirty patients were treated with oral spironolactone (50mg/day) with topical clindamycin 1% and the other thirty were given oral isotretinoin (10mg/day) with topical clindamycin 1%. Efficacy variables used were Global Acne Grading System (GAGS) score, Physicians Global Assessment (PGA) and Visual Analogue Scale (VAS). The response was evaluated fortnightly for a total period of 12 weeks.
Results: At the end of the study, there was a 32.8% reduction in GAGS scores in the spironolactone group and 68.4%, in the isotretinoin group. The response of female patients to acne vulgaris grade 1-2 with isotretinoin was superior to that of spironolactone and this difference was statistically significant (p<0.05). The side effects were minimal with no laboratory abnormalities.
Conclusion: Isotretinoin and spironolactone are both efficacious. However, isotretinoin is more efficacious than spironolactonein the treatment of acne vulgaris (grade 1-2).
Keywords: Acne vulgaris, Spironolactone, Isotretinoin, Clindamycin.
References
- Goulden V, Clark SM, Cunliffe WJ. Post-adolescent acne: a review of clinical features. Br J of Dermatol. 1997;136:66–70.
- Mallon E, Netwon JN, Klassen A, et al. The quality of life in acne: a comparison with general medical conditions using generic questionnaires. Br J Dermatol. 1999;140:672–6.
- Leyden JJ. New understanding of the pathogenesis of acne. J Am Acad Dermatol. 1995;32:515–25.
- Hermes B, Praetel C, Henz BM (September 1998). "Medium dose isotret-inoin for the treatment of acne". J Eur Acad Dermatol Venereol. 11 (2): 117–21.
- Goodfellow A, Alaghband-Zadeh J, Carter G, et al. Oral spironolactone improve acne vulgaris and reduced sebum excretion. Br J Dermatol. 1984;111:124–125.
- Erdemir U, Okan G, Gungor S, Tekin B, Yildiz SO, Yildiz E. The oral adverse effects of isotretinoin treatment in acne vulgaris patients: A prospective, case–control study. Niger J.Clin Pract 2017;20:860-6.
- Amichai B, Shemer A, Grunwald MH (April 2006). "Low-dose isotretinoin in the treatment of acne vulgaris". J. Am. Acad. Dermatol. 54 (4): 644–6.
- Sardana K, Garg VK, Sehgal VN, Mahajan S, Bhushan P. Efficacy of fixed low-dose isotretinoin (20 mg, alternate days) with topical clindamycin gel in moderately severe acne vulgaris. J Eur Acad Dermatol Venereol 2009;23:556-60
- Muhlemann M.F., Carter G.D., Cream J.J., Wise P. Oral spironolactone: an effective treatment for acne vulgaris in women. Br J Dermatol. 1986;115:227–232
- Vaswani N, Pandhi RK. Treatment of acne vulgaris with anti-androgens. Indian J Dermatol Venereol Leprol 1990;56:34–36.
- Charny JW, Choi JK, James WD. Spironolactone for the treatment of acne in women, a retrospective study of 110 patients. International Journal of Women’s Dermatology. 2017;3(2):111-115.