Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies
Condition: Scabies
MeSH terms: Scabies
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Blacksoap(R)
Intervention type(s): Other
Intervention description(s): Blacksoap(R)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Single (Investigator)
Primary purpose: Treatment