ScabiesNCT05025696
Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies
A study testing Blacksoap(R) in people with Scabies, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Scabies
- What is being tested?
- Blacksoap(R)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Sep 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Departemen Dermatologi dan Venereologi Fakultas Kedokteran Universitas Indonesia
Jakarta, Jakarta Pusat, 10430
About this study
Official title: Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies: a Single-blind Randomized Control Trial
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.
Read the 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).
- Conditions
- Scabies
- Being tested
- Blacksoap(R)
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blacksoap(R)Other
Blacksoap(R)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Blacksoap(R) applied whole body twice daily Receives: Other: Blacksoap(R) |
| Control | Placebo comparator | Johnson and Johnsons Baby Soap applied whole body twice daily Receives: Other: Blacksoap(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with scabies a week after first treatment
Number of participants with scabies a week after first treatment
Measured: One week
Number of participants with scabies four weeks after second treatment
Number of participants with scabies four weeks after second treatment
Measured: Four weeks
Transepidermal water loss in gr/hr/m^2 on first week
Skin barrier damage one week after first treatment
Measured: One week
Transepidermal water loss in gr/hr/m^2 on fourth week
Skin barrier damage one week after second treatment
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start18 Sep 2018
- Primary completion20 Oct 2018
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScabiesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Sandra Widaty, SpKK (K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025696
- Sponsor's protocol ID
- 18-08-0966
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Side Effects of Blacksoap® as Adjuvant Therapy of Scabies: a Single-blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05025696
- Acronym / sponsor ID
- 18-08-0966
- Conditions
- Scabies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Blacksoap(R)Blacksoap(R) applied whole body twice daily |
| Control | Placebo comparator | Other: Blacksoap(R)Johnson and Johnsons Baby Soap applied whole body twice daily |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blacksoap(R)Blacksoap(R) | Other | Control, Intervention |
Primary outcome
Number of participants with scabies a week after first treatment
Time frame: One week
Number of participants with scabies a week after first treatment
Number of participants with scabies four weeks after second treatment
Time frame: Four weeks
Number of participants with scabies four weeks after second treatment
Transepidermal water loss in gr/hr/m^2 on first week
Time frame: One week
Skin barrier damage one week after first treatment
Transepidermal water loss in gr/hr/m^2 on fourth week
Time frame: Four weeks
Skin barrier damage one week after second treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blacksoap(R) in people with Scabies, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with scabies a week after first treatment (time frame: One week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.