Better Disease Control by Multidrug Regimen in Scabies

Scabies Clinical Trial

Official title:

Better Disease Control by Multidrug Regimen in Scabies: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198947
• Other study ID #: 162/073/074-IRC
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2018

Study information

• Verified date: January 2022
• Source: B.P. Koirala Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Scabies is associated with significant discomfort and social taboo. Existing treatment regimen frequently fails due to lack of patient compliance. We compared single use regimen to existing standard repeat application regimen for treatment of scabies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

Inclusion Criteria:

• Willing patients

• Clinical diagnosis of scabies

• Within the age limits

Exclusion Criteria:

• Unwilling patients

• Patients with severe co-morbidities requiring long term medication

• Pregnant women

• Patients who don't fulfill the age limit criteria

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Permethrin Lotion 5%
Topical permethrin 5% lotion to apply on day 1 and repeat after 1 week.
• Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg
Topical permethrin 5% lotion and oral ivermectin 200 mcg/kg to be taken on day 1 only.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
B.P. Koirala Institute of Health Sciences

References & Publications (18)

1. Mushtaq A, Khurshid K, Pal SS. Comparison of efficacy and safety of oral ivermectin with topical permethrin in treatment of scabies. J Pakistan Assoc Dermatologists. 2010;20(4):227-31.

Arora P, Rudnicka L, Sar-Pomian M, Wollina U, Jafferany M, Lotti T, Sadoughifar R, Sitkowska Z, Goldust M. Scabies: A comprehensive review and current perspectives. Dermatol Ther. 2020 Jul;33(4):e13746. doi: 10.1111/dth.13746. Epub 2020 Jul 6. Review. — View Citation

Chandler DJ, Fuller LC. A Review of Scabies: An Infestation More than Skin Deep. Dermatology. 2019;235(2):79-90. doi: 10.1159/000495290. Epub 2018 Dec 13. Review. — View Citation

Chhaiya SB, Patel VJ, Dave JN, Mehta DS, Shah HA. Comparative efficacy and safety of topical permethrin, topical ivermectin, and oral ivermectin in patients of uncomplicated scabies. Indian J Dermatol Venereol Leprol. 2012 Sep-Oct;78(5):605-10. doi: 10.4103/0378-6323.100571. — View Citation

Dhana A, Yen H, Okhovat JP, Cho E, Keum N, Khumalo NP. Ivermectin versus permethrin in the treatment of scabies: A systematic review and meta-analysis of randomized controlled trials. J Am Acad Dermatol. 2018 Jan;78(1):194-198. doi: 10.1016/j.jaad.2017.09.006. Review. — View Citation

FitzGerald D, Grainger RJ, Reid A. Interventions for preventing the spread of infestation in close contacts of people with scabies. Cochrane Database Syst Rev. 2014 Feb 24;(2):CD009943. doi: 10.1002/14651858.CD009943.pub2. Review. — View Citation

Goldust M, Rezaee E, Hemayat S. Treatment of scabies: Comparison of permethrin 5% versus ivermectin. J Dermatol. 2012 Jun;39(6):545-7. doi: 10.1111/j.1346-8138.2011.01481.x. Epub 2012 Mar 5. — View Citation

Heukelbach J, Feldmeier H. Scabies. Lancet. 2006 May 27;367(9524):1767-74. Review. — View Citation

Heukelbach J, Mazigo HD, Ugbomoiko US. Impact of scabies in resource-poor communities. Curr Opin Infect Dis. 2013 Apr;26(2):127-32. doi: 10.1097/QCO.0b013e32835e847b. Review. — View Citation

Hicks MI, Elston DM. Scabies. Dermatol Ther. 2009 Jul-Aug;22(4):279-92. doi: 10.1111/j.1529-8019.2009.01243.x. Review. — View Citation

Mounsey KE, Holt DC, McCarthy J, Currie BJ, Walton SF. Scabies: molecular perspectives and therapeutic implications in the face of emerging drug resistance. Future Microbiol. 2008 Feb;3(1):57-66. doi: 10.2217/17460913.3.1.57. Review. — View Citation

Purvis RS, Tyring SK. An outbreak of lindane-resistant scabies treated successfully with permethrin 5% cream. J Am Acad Dermatol. 1991 Dec;25(6 Pt 1):1015-6. — View Citation

Rosumeck S, Nast A, Dressler C. Ivermectin and permethrin for treating scabies. Cochrane Database Syst Rev. 2018 Apr 2;4:CD012994. doi: 10.1002/14651858.CD012994. Review. — View Citation

Sharma R, Singal A. Topical permethrin and oral ivermectin in the management of scabies: a prospective, randomized, double blind, controlled study. Indian J Dermatol Venereol Leprol. 2011 Sep-Oct;77(5):581-6. doi: 10.4103/0378-6323.84063. — View Citation

Strong M, Johnstone P. Interventions for treating scabies. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD000320. Review. — View Citation

Sunderkötter C, Aebischer A, Neufeld M, Löser C, Kreuter A, Bialek R, Hamm H, Feldmeier H. Zunahme von Skabies in Deutschland und Entwicklung resistenter Krätzemilben? Evidenz und Konsequenz. J Dtsch Dermatol Ges. 2019 Jan;17(1):15-24. doi: 10.1111/ddg.13706_g. Review. — View Citation

Taplin D, Porcelain SL, Meinking TL, Athey RL, Chen JA, Castillero PM, Sanchez R. Community control of scabies: a model based on use of permethrin cream. Lancet. 1991 Apr 27;337(8748):1016-8. — View Citation

Trettin B, Lassen JA, Andersen F, Agerskov H. The journey of having scabies-a qualitative study. J Nurs Educ Pract. 2018;9(2):1.

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus	Rate of relief from pruritus assessed using visual analog scale	1 month
Secondary	Skin lesions	Rate of eradication of skin lesions assessed using physician global assessment scale	1 month