Sulfur vs. Different Regimes of Permethrin for Scabies

NCT06396507 | Completed Phase 3 DMC

• 1 other identifier: UDMS-Dermatology-06-2022
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 3

Brief Summary

In 2017, the World Health Organization (WHO) labeled scabies as a neglected tropical disease. It is a serious health problem especially in poor developing countries like Syria, where overcrowding, poverty, and war consequences are considered major factors for spreading the disease. Permethrin lotion or cream is the treatment of choice for scabies, and it is applied once a week for two consecutive weeks according to the global guidelines. However, most practitioners in Syria do not adhere to this standard regimen, and a variety of regimens are used instead based mostly on clinical experience. In this study, the investigators are comparing four different regimens of permethrin application and comparing Sulfur to permethrin in terms of efficacy and safety.

Conditions

Scabies

Keywords

Scabies; Permethrin; Sulfur; Skin Diseases; Parasitic Diseases; Sarcoptes scabiei; scabies mite; Skin Infectious Diseases

Outcome Measures

Primary Outcomes (1)

• Clinical Recovery

  Clinical recovery is defined as: * Absence of new scabietic skin lesions, AND * All remaining scabietic lesions are in healing, AND * Improvement of itch, defined by a decrease in itching grading score up to grade 0, 1, or 2 or a decrease for one grade, as for the participants who were diagnosed as grade 2 or less from the first visit. The variable is binary: Yes or No.

  At day 14 and 28 following the intervention.

Secondary Outcomes (2)

• Rate of adverse events

  At day 14 and 28 following the intervention.

• Verbal rating scale of pruritus

  At day 14 and 28 following the intervention.

Study Arms (5)

Arm P1

ACTIVE COMPARATOR

Permethrin 5% solution Participants randomly assigned to this group will apply the solution once, leave it on for ≥ 8 hours, rinse it, then reapply it the same way on day 8.

Drug: Permethrin Solution

Arm P2

EXPERIMENTAL

Permethrin 5% solution Participants randomly assigned to this group will apply the solution on days one, two, and three -for ≥ 8 hours each day- then rinse it (without rinsing in between these days) and reapply it on days eight, nine, and ten then rinse it.

Drug: Permethrin Solution

Arm P3

EXPERIMENTAL

Permethrin 5% solution Participants randomly assigned to this group will apply the solution on days one, two, and three -for ≥ 8 hours each day- then rinse it (without rinsing in between these days). They will reapply it on day eight and rinse it after ≥ 8 hours.

Drug: Permethrin Solution

Arm P4

EXPERIMENTAL

Permethrin 5% solution Participants assigned to this group will apply the solution on the first two days in the first week (for ≥ 8 hours each day with rinsing in between these days) and reapply it on day eight and rinse it after ≥ 8 hours.

Drug: Permethrin Solution

Arm S

EXPERIMENTAL

Sulfur 10%+ vaseline 90 % ointment Participants assigned to this group will apply the ointment for three consecutive days (for ≥ 8 hours each day and without rinsing in between these days).

Drug: Sulfur

Interventions

Permethrin Solution DRUG

permethrin 5 % solution

Also known as: Primothrin®, Permethrin®, Cidal®

Arm P1; Arm P2; Arm P3; Arm P4

Sulfur DRUG

Sulfur 10%+ vaseline 90 % ointment

Also known as: sulphur

Arm S

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Scabies participants who meet "The 2020 International Alliance for the Control of Scabies (IACS) Consensus Criteria" level A or B.
• Participants can apply the treatment themselves or by their guardians if they are children.
• Participants willing to commit to the study's requirements

You may not qualify if:

• Participants are younger than two years.
• Participants with other skin diseases that could interfere with their assessment.
• Participants who received treatment for scabies in the preceding month.
• Receiving treatment with corticosteroids in the preceding week.
• Pregnancy, planning for pregnancy during the study, or breastfeeding.
• Systemic infection or receiving systemic therapy for an infectious disease
• Immunocompromised Participants.
• Participants with crusted/Norwegian scabies.
• Having sensitivity or allergy to permethrin or sulfur.
• Participants with abnormal liver and kidney functions, thyroid disease, cardiac disorders, psychiatric illnesses.
• Participation of a family member, or another member of the household in the current study.
• The number of participants' households is seven or more.

Sponsors & Collaborators

• Damascus University: lead
• University of Aleppo: collaborator
• Tishreen University Hospital: collaborator

Study Sites (3)

University of Aleppo

Aleppo, 15310, Syria

Location

Faculty of Medicine, University of Damascus

Damascus, DM20AM19, Syria

Location

University of Tishreen

Latakia, 00000, Syria

Location

Related Publications (11)

• Walton SF, Currie BJ. Problems in diagnosing scabies, a global disease in human and animal populations. Clin Microbiol Rev. 2007 Apr;20(2):268-79. doi: 10.1128/CMR.00042-06.

  PMID: 17428886 BACKGROUND

• Hay RJ, Steer AC, Engelman D, Walton S. Scabies in the developing world--its prevalence, complications, and management. Clin Microbiol Infect. 2012 Apr;18(4):313-23. doi: 10.1111/j.1469-0691.2012.03798.x.

  PMID: 22429456 BACKGROUND

• Fuller LC. Epidemiology of scabies. Curr Opin Infect Dis. 2013 Apr;26(2):123-6. doi: 10.1097/QCO.0b013e32835eb851.

  PMID: 23411418 BACKGROUND

• Strong M, Johnstone P. Interventions for treating scabies. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD000320. doi: 10.1002/14651858.CD000320.pub2.

  PMID: 17636630 BACKGROUND

• Khalil S, Abbas O, Kibbi AG, Kurban M. Scabies in the age of increasing drug resistance. PLoS Negl Trop Dis. 2017 Nov 30;11(11):e0005920. doi: 10.1371/journal.pntd.0005920. eCollection 2017 Nov.

  PMID: 29190303 BACKGROUND

• Karthikeyan K. Treatment of scabies: newer perspectives. Postgrad Med J. 2005 Jan;81(951):7-11. doi: 10.1136/pgmj.2003.018390.

  PMID: 15640423 BACKGROUND

• Avila-Romay A, Alvarez-Franco M, Ruiz-Maldonado R. Therapeutic efficacy, secondary effects, and patient acceptability of 10% sulfur in either pork fat or cold cream for the treatment of scabies. Pediatr Dermatol. 1991 Mar;8(1):64-6. doi: 10.1111/j.1525-1470.1991.tb00844.x.

  PMID: 1862029 BACKGROUND

• Chosidow O. Scabies and pediculosis. Lancet. 2000 Mar 4;355(9206):819-26. doi: 10.1016/s0140-6736(99)09458-1.

  PMID: 10711939 BACKGROUND

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

  PMID: 29608022 BACKGROUND

• Engelman D, Yoshizumi J, Hay RJ, Osti M, Micali G, Norton S, Walton S, Boralevi F, Bernigaud C, Bowen AC, Chang AY, Chosidow O, Estrada-Chavez G, Feldmeier H, Ishii N, Lacarrubba F, Mahe A, Maurer T, Mahdi MMA, Murdoch ME, Pariser D, Nair PA, Rehmus W, Romani L, Tilakaratne D, Tuicakau M, Walker SL, Wanat KA, Whitfeld MJ, Yotsu RR, Steer AC, Fuller LC. The 2020 International Alliance for the Control of Scabies Consensus Criteria for the Diagnosis of Scabies. Br J Dermatol. 2020 Nov;183(5):808-820. doi: 10.1111/bjd.18943. Epub 2020 Mar 29.

  PMID: 32034956 BACKGROUND

• 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.

  PMID: 21860157 BACKGROUND

Related Links

• Randomisation
• Scabies Treatment \& Management: Approach Considerations, Pharmacologic Therapy, Prevention
• Society guideline links: Scabies

MeSH Terms

Conditions

Scabies; Skin Diseases; Parasitic Diseases; Skin Diseases, Infectious

Interventions

Permethrin; Sulfur

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes; Chalcogens; Elements; Inorganic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of the five groups (Permethrin 5% P1, P2, P3, P4, and sulfur S). Participants will be followed every two weeks for a month to evaluate primary and secondary outcomes.

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: May 2, 2024
• Study Start: March 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: November 12, 2022
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (3)