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
Panama	1
Puerto Rico	1

Trials by US State

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

ELIMITE Market Analysis and Financial Projection

Clinical Trials and Market Analysis for ELIMITE (Permethrin 5% Cream)

Introduction

ELIMITE, also known as permethrin 5% cream, is a topical treatment commonly used for scabies and lice infestations. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Efficacy and Safety

Clinical trials for ELIMITE have primarily focused on its efficacy and safety in treating scabies and lice infestations. Studies have shown that ELIMITE is effective in eliminating these parasites. For instance, approximately 75% of patients treated with ELIMITE who continued to manifest pruritus at 2 weeks showed significant improvement[4].

Adverse Reactions

The safety profile of ELIMITE has been well-documented. Common adverse reactions include mild and transient burning and stinging, pruritus, erythema, numbness, tingling, and rash. These side effects are generally mild and occur in a small percentage of patients[4].

Geriatric Use

Clinical studies have not identified significant differences in responses between elderly and younger patients. However, it is important to note that the drug is metabolized in the liver and excreted in the urine, which could be a consideration for patients with impaired renal function, although no increased risk has been observed when used as labeled[4].

Market Analysis

Current Market Status

The market for topical treatments like ELIMITE is stable, with a consistent demand driven by the prevalence of scabies and lice infestations. The market is not as dynamic as those for newer or more innovative treatments, but it remains a vital segment due to the ongoing need for effective parasitic treatments.

Competitive Landscape

The market for scabies and lice treatments includes several other products, such as oral ivermectin and other topical creams. However, ELIMITE remains a popular choice due to its efficacy and relatively safe profile. The competitive landscape is characterized by a mix of branded and generic products, with ELIMITE being one of the well-established brands.

Regulatory Environment

Regulatory approvals for ELIMITE have been maintained over the years, with no significant changes or updates that would impact its market position. The drug is widely approved and available in various regions, contributing to its stable market presence.

Market Projections

Demand and Growth

The demand for ELIMITE is expected to remain steady, driven by the consistent incidence of scabies and lice infestations. While the market may not experience rapid growth, it is anticipated to maintain its current level of sales. There are no significant market drivers or inhibitors expected to alter the demand for ELIMITE in the near future.

Pricing and Revenue

The pricing of ELIMITE is generally stable, with minimal fluctuations. Revenue projections indicate that the drug will continue to generate consistent sales, although the market share might be influenced by the introduction of new treatments or changes in consumer preferences.

Key Takeaways

• Efficacy and Safety: ELIMITE has been shown to be effective and safe in clinical trials, with a well-documented adverse reaction profile.
• Market Stability: The market for ELIMITE is stable, driven by consistent demand for scabies and lice treatments.
• Competitive Landscape: ELIMITE competes with other topical and oral treatments but remains a popular choice due to its efficacy and safety.
• Regulatory Environment: The drug has maintained its regulatory approvals and is widely available.
• Market Projections: Demand and revenue for ELIMITE are expected to remain steady with no significant growth or decline anticipated.

FAQs

1. What is ELIMITE used for? ELIMITE (permethrin 5% cream) is used for the treatment of scabies and lice infestations.

2. What are the common side effects of ELIMITE? Common side effects include mild and transient burning and stinging, pruritus, erythema, numbness, tingling, and rash.

3. Is ELIMITE safe for elderly patients? Clinical studies have not identified significant differences in responses between elderly and younger patients, although caution is advised due to renal function considerations.

4. How does ELIMITE compare to other treatments for scabies and lice? ELIMITE is a popular choice due to its efficacy and relatively safe profile, competing with other topical and oral treatments like ivermectin.

5. What are the market projections for ELIMITE? The market for ELIMITE is expected to remain stable, with consistent demand and no significant growth or decline anticipated.

References

[4] https://www.drugs.com/pro/elimite.html [3] https://www.biospace.com/press-releases/hiv-clinical-trials-market-size-expected-to-hit-usd-2-42-billion-by-2034 [5] https://www.mining.com/lithium-market-could-see-modest-recovery-in-2025-adams-intelligence/