Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies

NCT05025696 | Completed DMC

• 1 other identifier: 18-08-0966
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scabies

Outcome Measures

Primary Outcomes (4)

• Number of participants with scabies a week after first treatment

  Number of participants with scabies a week after first treatment

  One week

• Number of participants with scabies four weeks after second treatment

  Number of participants with scabies four weeks after second treatment

  Four weeks

• Transepidermal water loss in gr/hr/m^2 on first week

  Skin barrier damage one week after first treatment

  One week

• Transepidermal water loss in gr/hr/m^2 on fourth week

  Skin barrier damage one week after second treatment

  Four weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Blacksoap(R) applied whole body twice daily

Other: Blacksoap(R)

Control

PLACEBO COMPARATOR

Johnson and Johnsons Baby Soap applied whole body twice daily

Other: Blacksoap(R)

Interventions

Blacksoap(R) OTHER

Blacksoap(R)

Control; Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Students diagnosed with scabies and agreed to participate
• Age 12-18 years old
• Has been staying in the boarding school for at least 4 weeks

You may not qualify if:

• Not healthy (ie. fever or other conditions which caused subjects were not able to be examined)
• Secondary infection has been found ( yellow crusts, pus, dirty skin lesion, bullae, or systemic symptoms ie. fever)

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Departemen Dermatologi dan Venereologi Fakultas Kedokteran Universitas Indonesia

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Scabies

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators who scraped the skin and did the transepidermal water loss examination were blinded on which arm the subjects were allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Department of Dermatology Venereology, Faculty of Medicine Universitas Indonesia

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 27, 2021
• Study Start: September 18, 2018
• Primary Completion: October 20, 2018
• Study Completion: December 30, 2019
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)