CLINICAL TRIALS PROFILE FOR PERMETHRIN

505(b)(2) Clinical Trials for PERMETHRIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00927472 ↗	Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2009-08-01	In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
New Formulation	NCT00963508 ↗	Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2009-08-01	In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.
OTC	NCT00244439 ↗	Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2005-12-01	Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

All Clinical Trials for PERMETHRIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00376155 ↗	Comparison of Two Strategies for the Delivery of IPTc	Completed	Medical Research Council	Phase 4	2006-05-01	Antimalarial chemoprophylaxis can reduce morbidity and mortality from malaria in children. However, this approach to malaria control has not been implemented widely because of concerns over its possible effect on the development of resistance and natural immunity. Intermittent preventive treatment (IPT) may be able to achieve some of the beneficial effects of chemoprophylaxis without its drawbacks. Recently, it has been shown that IPT given to Senegalese children under the age of five years on three occasions during the malaria transmission season reduced the incidence of clinical malaria by approximately 90%. However, it is uncertain how this intervention can be most effectively delivered. Therefore, 26 Maternal and Child Health (MCH) trekking clinics in Upper River Division, south of the River Gambia, each with an average catchment population of 400-500 children under 5 years of age, will be randomly allocated to receive IPT from the MCH trekking team or from a IPT dispenser (village health worker, traditional birth attendant or a community mother based in a primary health care village). Treatment with a single dose of sulfadoxine /pyrimethamine (SP) plus three doses of amodiaquine will be given to all study subjects at monthly intervals on three occasions during the months of September, October and November. The primary end points will be the incidence of clinical attacks of malaria detected by passive case detection, and cost-effectiveness of the delivery methods. Important secondary endpoints will be the coverage and the equity of coverage of IPT in preventing malaria morbidity.
NCT00244439 ↗	Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice	Completed	Taro Pharmaceuticals USA	Phase 3	2005-12-01	Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
NCT00262418 ↗	Comparison of the Efficacy and Safety of Ivermectin to Permethrin	Completed	University Ghent	Phase 2	2004-07-01	Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies

Clinical Trial Conditions for PERMETHRIN

Condition Name

Condition Name for PERMETHRIN
Intervention	Trials
Scabies	18
Pediculosis Capitis	4
Pediculosis	3

Condition MeSH

Condition MeSH for PERMETHRIN
Intervention	Trials
Scabies	19
Lice Infestations	9
Parasitic Diseases	4

Clinical Trial Locations for PERMETHRIN

Trials by Country

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−

Trials by Country for PERMETHRIN
Location	Trials
United States	45
France	13
Pakistan	3
Puerto Rico	2
El Salvador	2

Trials by US State

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−

Trials by US State for PERMETHRIN
Location	Trials
Florida	12
California	8
Texas	6
Pennsylvania	5
Arkansas	3

Clinical Trial Progress for PERMETHRIN

Clinical Trial Phase

Clinical Trial Phase for PERMETHRIN
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	14
Phase 2	3

Clinical Trial Status

Clinical Trial Status for PERMETHRIN
Clinical Trial Phase	Trials
Completed	20
Recruiting	5
Unknown status	2

Clinical Trial Sponsors for PERMETHRIN

Sponsor Name

Sponsor Name for PERMETHRIN
Sponsor	Trials
bioRASI, LLC	4
Taro Pharmaceuticals USA	3
Concentrics Research	3

Sponsor Type

Sponsor Type for PERMETHRIN
Sponsor	Trials
Other	38
Industry	28
U.S. Fed	2

Permethrin: Clinical Trials, Market Analysis, and Projections

Introduction

Permethrin, a synthetic insecticide and acaricide, is widely used in various sectors, including agriculture, pharmaceuticals, and personal care. This article delves into the current state of clinical trials involving permethrin, its market analysis, and future projections.

Clinical Trials and Efficacy

Scabies Treatment

In the context of scabies treatment, clinical trials have yielded mixed results when comparing permethrin with other treatments. A recent study comparing topical permethrin 5% with benzyl benzoate 25% showed that permethrin demonstrated a lack of efficacy in the majority of scabies cases, while benzyl benzoate exhibited an excellent cure rate and reasonable tolerability[1].

However, a Cochrane review suggested that topical permethrin is generally considered the most effective agent for scabies treatment when treatment failure is the outcome measure. Yet, in direct comparisons, single-dose ivermectin has been found to be more effective than most topical agents, including permethrin[4].

Adverse Effects and Tolerability

Clinical trials have also highlighted the tolerability and adverse effects of permethrin. The study comparing permethrin with benzyl benzoate found that permethrin had excellent tolerability, with only a few patients reporting mild itching. In contrast, benzyl benzoate caused mild to moderate burning or stinging in some patients, although these symptoms were transient and did not lead to treatment discontinuation[1].

Market Analysis

Global Market Size and Growth

The global permethrin market is expected to experience significant growth over the coming years. By 2029, the market is projected to reach nearly $315.95 million, growing at a CAGR of 6.40% from 2023 to 2029[2][5].

Regional Dominance

The Asia-Pacific region is the dominant market for permethrin, driven by countries such as Australia, Japan, China, and India. These countries have a strong agricultural sector, which is a major consumer of permethrin for crop protection. India, in particular, is a significant producer of crops like rice, maize, wheat, and pulses, as well as spices, contributing to the high demand for permethrin[2][5].

Europe is the second-largest market, driven by the growth of pharmaceutical industries and increasing health awareness among consumers. Countries like France, the UK, Germany, and Italy are key contributors to this growth[2][5].

Application Segments

Permethrin is used across various segments, including agricultural, pharmaceutical, personal care, and textile industries. In agriculture, it is used as a broad-spectrum insecticide to protect crops such as cotton, wheat, maize, and alfalfa. In the pharmaceutical sector, it is used for treating scabies and other parasitic infestations. Personal care products, such as bug sprays and shampoos, also utilize permethrin[2].

Market Dynamics

Drivers

The demand for permethrin is driven by several factors, including the increasing awareness of health and the need for effective pest control in agriculture. Rising research and development activities, particularly in the pharmaceutical and agricultural sectors, are also boosting the market. The use of permethrin as a repellant for several insects and its effectiveness against parasites are additional drivers[2].

Challenges

Despite its benefits, the permethrin market faces several challenges. High doses of permethrin can be lethal and injurious to health, which restricts its sales and requires medical supervision. Government regulations due to its side effects also pose a challenge for market players. Additionally, permethrin's impact on beneficial insects like honey bees and aquatic life can hamper market growth[2].

Future Projections

Growth Opportunities

The permethrin market is expected to grow significantly, driven by the expanding agricultural and pharmaceutical sectors. The increasing demand for bug sprays and other personal care products containing permethrin will also contribute to market growth. Clinical trials and government initiatives aimed at finding solutions for unmet medical diseases will further boost the market[2][5].

Competitive Landscape

The global permethrin market is competitive, with key players such as Bluebell Pharma, Kalyani Industries, Crop Life Science, and Bayer. These companies are focusing on research and development to enhance the efficacy and safety of permethrin products. The market is also seeing the entry of new players, which is expected to increase competition and drive innovation[2][5].

Key Takeaways

• Clinical Trials: Permethrin's efficacy in treating scabies is mixed, with some studies showing it to be less effective than benzyl benzoate or ivermectin.
• Market Size: The global permethrin market is projected to reach $315.95 million by 2029, growing at a CAGR of 6.40%.
• Regional Dominance: The Asia-Pacific region, particularly India, China, and Japan, dominates the market due to its strong agricultural sector.
• Application Segments: Permethrin is used in agriculture, pharmaceuticals, personal care, and textiles.
• Market Dynamics: The market is driven by health awareness and agricultural needs but faces challenges from side effects and regulatory issues.

FAQs

What is the current state of permethrin in clinical trials for scabies treatment?

Permethrin has shown mixed results in clinical trials for scabies treatment. While it is generally considered effective, recent studies suggest it may be less effective than benzyl benzoate or ivermectin in some cases[1][4].

What are the primary applications of permethrin?

Permethrin is primarily used in the agricultural sector to protect crops from insects, in the pharmaceutical sector for treating scabies and other parasitic infestations, and in personal care products such as bug sprays and shampoos[2].

Which regions dominate the global permethrin market?

The Asia-Pacific region, particularly countries like India, China, and Japan, dominates the global permethrin market due to its strong agricultural sector. Europe is the second-largest market, driven by the growth of pharmaceutical industries[2][5].

What are the challenges facing the permethrin market?

The permethrin market faces challenges from the potential side effects of high doses, which require medical supervision, and government regulations. Additionally, its impact on beneficial insects and aquatic life can hamper market growth[2].

Who are the key players in the global permethrin market?

Key players include Bluebell Pharma, Kalyani Industries, Crop Life Science, Kangmei Chemical, and Bayer. These companies are involved in research and development to enhance the efficacy and safety of permethrin products[2][5].

What is the projected growth rate of the global permethrin market?

The global permethrin market is expected to grow at a CAGR of 6.40% from 2023 to 2029, reaching a market size of nearly $315.95 million by 2029[2][5].

Sources

1. Comparison of topical permethrin 5% vs. benzyl benzoate 25% for the treatment of scabies - British Journal of Dermatology
2. Permethrin Market: Industry Analysis and Forecast (2023-2029) - Maximize Market Research
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace
4. Scabies: A clinical update - Royal Australian College of General Practitioners
5. Global Permethrin Market Size, Growth, Share| 2024 to 2029 - Market Data Forecast