Skabi-Rid Lotion

Skabi-Rid Permethrin 5% lotion     

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Skabi-Rid is a skin lotion for the treatment of scabies caused by Sarcoptis scabiei. It is the drug of choice for this condition and has the most favourable side effect profile of all treatments.

  • Treatment of Choice Worldwide for more than 10 years
  • Listed on WHO Essential Drug List
  • Permethrin 5% is FDA Approved
  • Reg No: A40/13.2/0756
  • Nappi Code: 713148-001
  • Barcode: 6009665060002

Skabi-Rid was developed out of need for a new, safer, more effective and simpler treatment for scabies. This condition affects more than 300 million people worldwide every year.

Compliance in treating is essential as incomplete treatment leads to resistance, spreading of the disease and further morbidity. This application cures scabies with a single application. The formulation was developed by the Research Institute for Industrial Pharmacy, Potchefstroom.

Active Ingredient:
Skabi-Rid contains permethrin 5% (5g in 100g). Permethrin belongs to a group of toxins called the pyrethroids, synthetic derivatives of pyrethrins designed to be stable in ultraviolet light, whilst retaining the potent insecticidal properties.

Pyrethrins originate from the chrysanthemum genus of plants originally from China; these plants were cultivated in China as a flowering herb as far back as the 15th century BC. About 200 years ago people living in central Asia discovered that dried, crushed flowers of certain chrysanthemums were toxic to insects.

 

No more scratching around for first line treatment of Scabies

Better Efficacy
Proven to be more effective than

  • Oral ivermectin
  • Topical crotamiton
  • Topical lindane

As effective as benzyl benzoate
Efficacy in resistant lice infestation

Better Compliance

  • One single application

Best safety profile of all scabies treatment

  • Less irritation than benzyl benzoate & lindane
  • Treatment of choice for pregnant women in the US and UK
    CDC 1998 Guidelines for treatment of sexually transmitted diseases. MMWR 1998;47:1116.
    Clinical Effectiveness Group (Association of Genitourinary Medicine and the Medical Society for the Study of Venereal Diseases). National guideline for the management of scabies. Sex Transm Inf 1999;75 (Suppl):S767
    The risk of foetal toxicity following maternal application of permethrin is likely to be no greater than that for the general population
    (Drugs.com (sources include Micromedex™, Wolters Kluwer™)
  • First line treatment for scabies in AIDS patients
  • Treatment of choice for lactating women

 

 

Clinical Trial

In the development of Skabi-Rid, the following clinical trial was performed:
A single centre randomised investigator blind, parallel group study to determine the safety and efficacy of a single application of permethrin 5% lotion versus two applications of a benzyl benzoate 25% emulsion in the treatment of scabies. The study was performed by SACT (South African Clincal Trials) and lead by prof. Otto Müller.

Primary Objective:

To evaluate the efficacy of a single application of permethrin 5% lotion as compared to a benzyl benzoate 25% emulsion applied as two separate applications 12 hours apart in the treatment of scabies as determined by the treatment response at day 29 or early discontinuation visit.

Secondary objectives:

  • To evaluate the safety and tolerability of a single application of permethrin 5% lotion as compared to two separate applications of a benzyl benzoate 25% emulsion, 12 hours apart, in the treatment of scabies as determined by the reported and observed adverse events and changes in clinical laboratory values.
  • To evaluate the efficacy of a single application of permethrin 5% lotion as compared to two separate applications of a benzyl benzoate 25% emulsion, 12 hours apart, in the treatment of scabies as determined by the treatment response at day 15
  • To evaluate the difference between the two treatment groups in the changes in the severity of pruritis from baseline to Day 29 on the modified pruritis score scale.
  • To evaluate the differences between the two treatment groups in the changes in severity of infestation from baseline to Day 29 on a 5-point scale.


Methodology:

Single centre investigator-blind, randomised, parallel group, active-controlled study in patients with scabies

Number of patients:

A total of 120 volunteers(36.7% male and 63.3% female) were randomised - 60 volunteers to permethrin 5% lotion and 60 volunteers to benzyl benzoate 25% emulsion. All volunteers randomised received the relevant investigational products.

Diagnosis and main criteria for inclusion:

Volunteers with clinical and/or parasitological signs and symptoms compatible with scabies defined as:

  • demonstration by light microscopy of eggs, larvae, mites or faecal pellets in skin scrapings. or
  • presence of at least three (3) of the following clinical criteria:
    • demonstration of a burrow
    • presence of scabetic lesions at the classical sites
    • nocturnal pruritis
    • family history of similar illness

To prevent re-infection by untreated individuals, all infected household members were invited to participate in the study. Those who did not participate in the study had to agree to be treated with benzyl benzoate 25% emulsion for the primary candidate to be eligible for the study.

Test product:
Permethrin 5% lotion - TomarMed (Pty) Ltd
Mode of administration: topical application
Batch number TT031

Reference product:
Benzyl benzoate 25% emulsion (Ascabiol) - Pharmacare Ltd.
Mode of administration: Topical application Batch No: 226686 Permethrin 5% matching placebo Lotion - TomarMed (Pty) Ltd Mode of administration: topical application
Batch Number: TT030


Treatment and duration of treatment:
Volunteers were randomised in a 1:1 ratio, investigator-blind design to one of the following treatments:

  • Treatment A: benzyl benzoate 25% emulsion (two applications 12 ± 2 hours apart)
  • Treatment B: permethrin 5 % lotion (single application of active followed by a single application of placebo 12 ± 2 hours later.

Willing household contacts were treated with benzyl benzoate 25% emulsion according to the South African Department of Health Standard Treatment Guidelines (1998) for Primary Health Care.

Primary efficacy endpoint:
Treatment response on Day 29 or early discontinuation visit, defined as:

  • Cure: No pruritis, no skin lesions, absence of mites or their products on microscopy
  • Moderate improvement: Improvement in pruritis, > 50% reduction in skin lesions, no new lesions, absence of mites or their products on microscopy.
  • Mild improvement: Improvement in pruritis, ≤ 50% reduction in skin lesions, no new lesions, absence of mites or their products on microscopy.
  • Treatment failure: No improvement in pruritis and no reduction in the number of skin lesions, or appearance of skin lesions, or presence of mites or their products on microscopy.


Safety and tolerability:

  • Adverse events
  • Clinical laboratory values (for haematology, clinical chemistry and urinalysis).



Summary of Results

  • Efficacy:
    Treatment with permethrin 5% lotion was associated with a 70.7% cure rate on Day 29, compared to a 67.8% cure rate in volunteers treated with benzyl benzoate 25% emulsion (p=> 0. 5)
  • A greater proportion of volunteers in the permethrin treated group had no residual skin lesions at Day 29 (86,2%), compared to those treated with benzyl benzoate (76.3%).
  • Safety:
    Permethrin lotion 5% and benzyl benzoate 25% emulsion were both well tolerated. Most adverse events were mild in intensity and were considered unrelated to the investigational products. The most common adverse event that appeared to be drug related was a transient burning sensation of the skin starting soon after the first application of scabicide. This is a known side effect of benzyl benzoate and to a lesser extent, permethrin. No significant changes were seen in any of the laboratory parameters during the study.

 

  • Conclusion
    Permethrin 5% lotion and benzyl benzoate 25% emulsion demonstrated similar efficacy with regard to the parameters measured. Permethrin 5% lotion offers an advantage for compliance of treatment over benzyl benzoate because of its superior safety profile and the fact that it involves just a single application.

    The study outcome justifies the recommendation of the South African Standard Treatment Guidelines and Essential Drugs List for Primary Health Care (1996), that permethrin 5% formulation be used as first line treatment for scabies.

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