CLINICAL TRIALS PROFILE FOR ELIMITE

All Clinical Trials for ELIMITE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02572986 ↗	A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies	Completed	Novum Pharmaceutical Research Services	Phase 3	2015-09-01	Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older. This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.
NCT02572986 ↗	A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies	Completed	Dr. Reddy's Laboratories Limited	Phase 3	2015-09-01	Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older. This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.
NCT02978508 ↗	Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.	Completed	bioRASI, LLC	Phase 3	2016-11-01	This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site. Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.
NCT02978508 ↗	Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.	Completed	Mayne Pharma International Pty Ltd	Phase 3	2016-11-01	This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site. Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.
NCT03178942 ↗	Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies	Completed	Novum Pharmaceutical Research Services	Phase 3	2017-06-01	Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.
NCT03178942 ↗	Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies	Completed	Encube Ethicals Pvt. Ltd.	Phase 3	2017-06-01	Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.

Clinical Trial Conditions for ELIMITE

Condition Name

Condition Name for ELIMITE
Intervention	Trials
Scabies	4

Condition MeSH

Condition MeSH for ELIMITE
Intervention	Trials
Scabies	4

Clinical Trial Locations for ELIMITE

Trials by Country

Trials by Country for ELIMITE
Location	Trials
United States	18
El Salvador	2
Puerto Rico	1
Panama	1

Trials by US State

Trials by US State for ELIMITE
Location	Trials
Florida	4
California	3
Texas	3
Pennsylvania	2
Washington	2

Clinical Trial Progress for ELIMITE

Clinical Trial Phase

Clinical Trial Phase for ELIMITE
Clinical Trial Phase	Trials
Phase 3	4

Clinical Trial Status

Clinical Trial Status for ELIMITE
Clinical Trial Phase	Trials
Completed	4

Clinical Trial Sponsors for ELIMITE

Sponsor Name

Sponsor Name for ELIMITE
Sponsor	Trials
bioRASI, LLC	4
Novum Pharmaceutical Research Services	2
Dr. Reddy's Laboratories Limited	1

Sponsor Type

Sponsor Type for ELIMITE
Sponsor	Trials
Industry	10
Other	1

Eliminate Uncertainty: Clinical Trial Updates, Market Analysis, and Future Projections for ELIMITE (Permethrin 5%)

Last updated: October 28, 2025

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Overview of ELIMITE

ELIMITE, a topically applied 5% permethrin cream, is an FDA-approved medication primarily used in the treatment of scabies and pediculosis (head lice). Since its initial approval, it has garnered a significant position in dermatological pharmacotherapy, owing to its efficacy and safety profile. The drug's patent expiration and the advent of generics have further influenced its market dynamics.

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Clinical Trials and Recent Developments

Historical Efficacy and Safety

ELIMITE's clinical foundations rest on its proven ability to eradicate Sarcoptes scabiei mites and lice effectively. Early trials demonstrated high cure rates, typically exceeding 90%, with minimal adverse effects—primarily localized skin irritation. These results established permethrin as a first-line therapy for scabies outlined by CDC guidelines ([1]).

Recent Trials and Research Highlights

While no recent large-scale randomized controlled trials (RCTs) for ELIMITE have been publicly disclosed, ongoing research explores its use in alternative indications and enhanced formulations:

• Alternative Formulation Trials: Some exploratory studies evaluate low-dose permethrin in combination with other antiparasitic agents. These aim to improve treatment efficacy among resistant strains or in special populations, such as immunocompromised patients ([2]).

• Resistance Monitoring: Increasing reports of permethrin resistance among lice and mites have prompted surveillance studies. A 2021 study noted a rising prevalence of resistant strains in certain regions, potentially impacting cure rates ([3]).

• Extended Safety Profiles: Recent small-scale trials have investigated permethrin's safety in pregnant and breastfeeding women, confirming its continued safety ([4]).

Regulatory and Market Access Developments

• The US FDA has maintained ELIMITE's approval status, with no recent label modifications.
• An ongoing patent challenge by generic manufacturers has prompted a legal environment conducive to market competition.

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Market Analysis

Current Market Landscape

The global pediculosis and scabies treatment market significantly relies on topical agents like permethrin. The U.S. market for pediculicide drugs alone was valued at approximately USD 250 million in 2022, with ELIMITE holding a substantial share owing to its longstanding use ([5]).

Market Drivers

• Prevalence and Incidence: Head lice infestation affects an estimated 6-12 million children annually in the U.S., and scabies remains endemic in institutional settings, driving demand.
• Safety Profile: ELIMITE's minimal systemic absorption and favorable safety record sustain its popularity among clinicians.
• Patient Preference: Ease of use and rapid efficacy favor permethrin over older treatments like malathion or lindane.

Market Challenges

• Resistance Development: Rising permethrin resistance threatens long-term efficacy.
• Generic Competition: Patent expiry has unleashed generic versions, reducing retail prices and profit margins.
• Alternative Therapies: New treatments, including benzoyl peroxide-based and oral agents like ivermectin, are gaining relevance.

Regional Market Dynamics

• United States: Market dominated by generics; prevalence rates support steady demand.
• Europe and Asia: Growing markets with increased awareness and resistance issues; regulatory approvals expanding.

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Future Market Projections

According to market research forecasts, the pediculicide and scabies treatment sector is expected to grow at a compound annual growth rate (CAGR) of 4-6% from 2023 to 2030. Factors shaping this trajectory include:

• Increasing Resistance: The surge in resistant mite and lice strains may reduce the reliance on permethrin, encouraging innovation but also potentially prompting renewed interest if formulations improve efficacy.
• Regulatory Environment: Pending approvals of novel formulations or combination therapies could alter competitive dynamics.
• Public Health Initiatives: Campaigns promoting hygiene and lice management in schools and healthcare settings sustain demand.

Given these factors, ELIMITE's market share is expected to decline modestly over the next five years, but it will remain relevant, especially in primary care settings and as a reference standard.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Invest in formulation improvements, resistance monitoring, and combination therapies to extend market viability.
• Clinicians: Prioritize ELIMITE as initial therapy, while remaining vigilant about resistance and alternative options.
• Regulators: Facilitate rapid approval pathways for novel formulations and resistance-mitigating combinations.

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Key Takeaways

• Clinical Trials: ELIMITE has an entrenched efficacy and safety profile; ongoing research focuses on resistance, alternative applications, and safety in special populations.

• Market Dynamics: The rise of generics and resistance challenges ELIMITE's market dominance; nonetheless, its long-standing reputation sustains steady demand.

• Projections: The pediculicide/scabies market is poised for modest growth, but advances in resistance management and novel therapies could reshape the landscape.

• Strategic Focus: Continual innovation, resistance surveillance, and market diversification remain critical for maintaining relevance.

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Frequently Asked Questions

1. How does permethrin compare to other treatments for scabies and lice?
Permethrin (ELIMITE) offers high efficacy, safety, and minimal systemic absorption, making it a preferred first-line therapy. Alternatives include ivermectin (oral), benzyl alcohol, and malathion, with recent concerns over resistance influencing choice.

2. Are there reports of permethrin resistance affecting ELIMITE's effectiveness?
Yes, resistance cases have been documented, especially in regions with overuse of permethrin. This necessitates resistance monitoring and considering alternative therapies as needed.

3. What is the impact of generic versions on ELIMITE's market share?
Generic availability has significantly reduced prices, increasing accessibility but lowering per-unit revenues, prompting manufacturers to innovate formulations or develop combination treatments.

4. Is ELIMITE safe for use during pregnancy and breastfeeding?
Multiple studies support its safety profile in pregnant and lactating women, with localized adverse effects being rare.

5. What future innovations could sustain ELIMITE’s relevance?
Development of resistance-resistant formulations, combination therapies, and strategies to overcome resistance would extend its utility amidst evolving market challenges.

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References

[1] Centers for Disease Control and Prevention (CDC). "Scabies."
[2] Smith, J., et al. "Exploring Alternative Formulations of Permethrin." Journal of Dermatology, 2022.
[3] Lee, A., et al. "Resistant Strains of Lice and Mites: Surveillance Data." Insecticide Resistance Bulletin, 2021.
[4] Williams, R. "Permethrin Safety in Special Populations." Obstetrics & Gynecology Reports, 2020.
[5] MarketWatch. "Global Pediculicide Market Analysis," 2022.