An interventional study of Blacksoap(R) in Scabies, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by Indonesia University · Not applicable, Interventional, and Treatment
Background: Scabies is a skin disease due to Sarcoptes scabiei. The transmission risk is high among communities living together, such as dormitories, boarding schools, nursing homes, and so on. Blacksoap® is a soap product that is recognized as adjuvant therapy. Until now, there has been no research on the effectiveness and side effects of using Blacksoap®. Purpose: This research aimed to assess the cure rate of standard scabies treatment, with and without Blacksoap®, to determine pruritus visual analog scale (VAS) score, transepidermal water loss (TEWL) score before and after receiving therapy, and to evaluate the side effects of the treatment. Methods: The intervention group obtained standard therapy and Blacksoap®; meanwhile, the control group received standard therapy and baby soap.
This study is a single-blind randomized clinical trial on scabies patient population at Pondok Pesantren Al Islami, Cibinong, Bogor. It is part of a research and social service by the Dermatology and Venereology Department of Faculty of Medicine Universitas Indonesia / dr. Cipto Mangunkusumo National Central General Hospital entitled "Early Detection of Scabies and Other Dermatoses and Evaluation of Scabies Treatment in Al-Hidayah and Al Islami Islamic Boarding School" Research subjects who are participating are those diagnosed with scabies (fulfilling 2 out of 4 cardinal signs of scabies).
The research was conducted from September to October 2018 with the entire scabies patient in Indonesia as the target population, and all students at Al Islami Boarding School who at the time had scabies as the accessible population. A random cluster sampling was done on the population member diagnosed with scabies based on the boarding school building location into the intervention group and control group. The intervention group was receiving permethrin 5% cream and Blacksoap®, while the control group was receiving permethrin 5% cream and baby soap.
Skin scraping examination was done on the research subjects with potassium hydroxide (KOH) solution to find the mites, alongside pruritus visual analog scale (VAS) score assessment and transepidermal water loss (TEWL) measurement before suitable therapy given. In the first and fourth weeks after the initial assessment, which includes the scabies cure rate, pruritus VAS score, TEWL score, and side effects evaluation, a follow-up was conducted. TEWL was measured using Tewameter® TM 300 made by Courage-Khazaka from Germany. Subsequent data were documented and processed using Statistical Product and Service Product (SPSS) program version 20. Finally, an analysis was done by a third-party which did not seem aware of the treatment given (single-blind).
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 78 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Blacksoap(R) applied whole body twice daily
Other: Blacksoap(R)
Johnson and Johnsons Baby Soap applied whole body twice daily
Other: Blacksoap(R)
Blacksoap(R)
Number of participants with scabies a week after first treatment
Number of participants with scabies a week after first treatment
Time frame: One week
Number of participants with scabies four weeks after second treatment
Number of participants with scabies four weeks after second treatment
Time frame: Four weeks
Transepidermal water loss in gr/hr/m^2 on first week
Skin barrier damage one week after first treatment
Time frame: One week
Transepidermal water loss in gr/hr/m^2 on fourth week
Skin barrier damage one week after second treatment
Time frame: Four weeks
Plan to share: No
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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