STUDY OF EFFICACY, SAFETY & TOLERABILITY OF ORAL ISOTRETINOIN IN PATIENTS OF MODERATE TO SEVERE ACNE VULGARIES

Abstract

BACKGROUND:Acne vulgaris is an almost universal problem of adolescence characterized by inflammation in and around sebaceous gland. Effective treatment is essential to prevent physical and psychological scarring. Antibiotic requires frequent administration and associated with side effects contributing to reduced compliance . Isotretinoin was a major therapeutic advanced which revolutionized the treatment of acne. Thus it is important to analyze its risk-benefit ratio at lower dosages. Hence the present study carried out with the objective of oral Isotretinoin in patients of moderate to severe grade acne vulgaris. METHODOLOGY: The present prospective study carried out among the acne vulgaris cases attending the out-patient department of dermatology at a tertiary care Centre during January 2007 to December 2007. Oral is otretinoin was started at a dose of 0.5 mg/kg/day for a total duration of 20 weeks. Patients were scheduled for 3 visits i.e. at the end of 1 st , 2nd & 5 th month after start of treatment. All collected data entered and analyzed using SPSS for efficacy of drug on different lesions. RESULTS: 38 (95%) patients completed the study and same were evaluated for efficacy and safety. 50% decrease in comedons at the end of 2 month from the initiation of treatment. The efficacy of oral isotretinoin on inflammatory lesions shows decreased from baseline 36.13 to 4.87 at the time of last visit at 5 month. This was statistically significant (0.0001). Side effects observed an 11% case includes dryness, palmoplantar peeling, exfoliative dermatitis, photosensitivity, facial dermatitis. CONCLUSION: The oral is otretino in is effective and safe as well as showing early response especially for inflammatory lesions.

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“…In their study oral isotretinoin was administered in initial dose of 10 mg/day with a variable increase according to tolerability, reaching a mean dose 0.43 mg/kg and reported very good results in 62.8% and good results in 31.9% of patients. Chetan D et al 16 studied 38 patients and found 50% decrease in comedons at the end of 2 month from the initiation of treatment. The efficacy of oral isotretinoin on inflammatory lesions showed decreased from baseline 36.13 to 4.87 at the time of last visit at 5 month.…”

“…Efficacy was determined by evaluating inflammatory lesions count at baseline and at every visit. 16 Institutional ethical committee approval was taken prior to the study. Written informed valid consent of the Patients fitting into the criteria was taken.…”