[Efficacy, safety and acceptability of precipitated sulphur petrolatum for topical treatment of scabies at the city of Coro, Falcon State, Venezuela].

INTRODUCTION

In spite of sulphur ointment has been applied during centuries in the treatment of human scabies, nevertheless, its clinical efficacy, as well as safety and acceptability has not been clearly demonstrated.

AIM: During September 2001-March 2002, attempts have been made to assess the efficacy, safety and acceptability of a mixture of precipitated sulphur 2-8% petrolatum for the treatment of 40 ambulatory consultant patients, of all age groups, including children under 1 year of age, pregnant and lacting women, with suggestive sarcoptic cutaneous lesions from Coro, Falcon State, Venezuela.

METHODS

The diagnosis was made by clinical examination and microscope observation (KOH 10%) of scrapings of cutaneous lesions. The acceptability were quantified using visual analogue scale (VAS) and other two behavioral (BS) scores. Enrolled patients applied ointment 1 daily dose for 6 days, 1 week rest, repeated for 2 days, thoroughly washing off with neutral soap and applying lubricant cream. Differential schedule concentrations were: 2% for children below 2 years and up to 6 years old; 2-5% for scholars, adolescents and pregnant; 5-8% for adults and elderly; being exposition time to the ointment of 3 hours for children under 2 years old, and overnight for reminding age-groups. Efficacy was evaluated 7-30 days post-treatment by clinic observation, quantification and scraping of the sarcoptic lesions. A safety assessment was based on adverse effects reported by patients or observed by the physician.

RESULTS

38 (95%) out of 40 patients were clinical and ectoparasitologically cured 7-30 days after cessation of ointment application, with no relapses or relevant adverse effects, producing a significant (t = 9.26; p < 0.0001) decrease at the end of evaluation period in the median values of number of lesions (28.08-9.18 vs. 0.00). Only 2 (5%) patients developed a mild dermatitis reaction, and subsequently no completed the follow up.

CONCLUSION

It's proven highly therapeutic effectiveness as well as widely availability, low costs with no serious side effects and satisfactory acceptability (X; VAS = 1.14 +/- 1.67; BS: 0.25 +/- 0.38, 0.53 +/- 0.43), allows us to recommend the topical use of the ointment sulfur-petrolatum for the treatment of human scabies, especially in children under 5 years of age, pregnant and lactating women and elderly, in which other drugs are not recommended by its potential toxicity.