CLINICAL TRIALS PROFILE FOR LINDANE

All Clinical Trials for LINDANE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00604084 ↗	Veron Scabies Education and Eradication Program	Completed	Edward Via Virginia College of Osteopathic Medicine	N/A	2007-05-01	The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community on the eastern tip of the Dominican Republic. It proposes the use of oral Ivermectin as a replacement for topical Lindane--a readily available medical formulation, pesticide, and environmental toxin that is reported to be banned in the Dominican Republic as well as over 80 other countries throughout the world.
NCT06396507 ↗	Sulfur vs. Different Regimes of Permethrin for Scabies	COMPLETED	Tishreen University Hospital	PHASE3	2022-03-15	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.
NCT06396507 ↗	Sulfur vs. Different Regimes of Permethrin for Scabies	COMPLETED	University of Aleppo	PHASE3	2022-03-15	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.
NCT06396507 ↗	Sulfur vs. Different Regimes of Permethrin for Scabies	COMPLETED	Damascus University	PHASE3	2022-03-15	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.

Clinical Trial Conditions for LINDANE

Condition Name

Condition Name for LINDANE
Intervention	Trials
Scabies	2

Condition MeSH

Condition MeSH for LINDANE
Intervention	Trials
Scabies	2
Skin Diseases, Infectious	1
Skin Diseases	1
Parasitic Diseases	1

Clinical Trial Locations for LINDANE

Trials by Country

Trials by Country for LINDANE
Location	Trials
Syria	1
Dominican Republic	1

Clinical Trial Progress for LINDANE

Clinical Trial Phase

Clinical Trial Phase for LINDANE
Clinical Trial Phase	Trials
PHASE3	1
N/A	1

Clinical Trial Status

Clinical Trial Status for LINDANE
Clinical Trial Phase	Trials
COMPLETED	2

Clinical Trial Sponsors for LINDANE

Sponsor Name

Sponsor Name for LINDANE
Sponsor	Trials
Damascus University	1
Edward Via Virginia College of Osteopathic Medicine	1
Tishreen University Hospital	1

Sponsor Type

Sponsor Type for LINDANE
Sponsor	Trials
Other	4

Lindane: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 7, 2025

Introduction

Lindane (gamma-hexachlorocyclohexane) is a pesticide historically used in dermatology for treating scabies and lice infestations. Its regulatory status has shifted significantly over recent decades due to safety concerns, environmental impact, and the availability of safer alternatives. Despite its decline, lindane remains relevant in specific markets, prompting continual evaluation of its clinical development, market dynamics, and future outlook.

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Clinical Trials Update

Current Clinical Status

Lindane's clinical research phase is predominantly focused on safety reassessment, alternative formulations, and investigating the molecular mechanisms underlying toxicity. Over the last five years, there have been limited new clinical trials involving lindane, primarily due to regulatory restrictions imposed by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Regulatory Constraints and Clinical Implications

The limited ongoing clinical trial activity is attributable to lindane’s classification as a hazardous substance. The CDC and FDA have revoked or restricted its use in many jurisdictions, citing neurotoxicity, endocrine disruption, and environmental persistence. As of 2022, the FDA’s label explicitly contraindicates lindane for pediatric use and recommends alternative treatments for scabies and lice [1].

Research Focus

Most current research is post-market surveillance of its safety profile rather than novel clinical trials. The focus includes:

• Toxicity surveillance: Ongoing studies analyze long-term neurotoxic and carcinogenic risks.
• Environmental impact assessments: Studies examine lindane’s persistence and bioaccumulation in ecosystems.
• Formulation development: Research into safer derivatives or controlled-release formulations to mitigate toxicity is ongoing, though clinical trials are limited.

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Market Analysis

Historical Market Dynamics

Lindane's decline began in the early 2000s as safer, more effective alternatives—such as permethrin and malathion—became available. The global market for lindane peaked in the 1990s, primarily serving developing nations where regulatory enforcement was less stringent [2].

Regulatory Landscape and Market Constraints

• Regulatory bans: The Stockholm Convention on Persistent Organic Pollutants, effective from 2004, targeted lindane for global phase-out due to its environmental persistence and bioaccumulation potential [3].
• United States and Europe: Lindane’s use is restricted or banned, leading to a steep decline in domestic sales.
• Emerging Markets: Some Asian and African countries still utilize lindane, driven by cost considerations and limited access to alternatives.

Market Segments & Revenue Streams

• Pesticide Use: Limited domestically; predominantly phased out.
• Dermatological Applications: Significantly diminished; only a handful of markets permit licensed formulations, primarily for veterinary or residual medical use.
• Environmental and Regulatory Compliance Services: Growing niche involving monitoring lindane-contaminated sites.

Market Size and Forecast

Given the global regulatory stance, the lindane market is now primarily composed of:

• Legacy stockpiles management
• Environmental remediation services
• Specialized uses in select countries

The global lindane market value was estimated to be less than USD 10 million in 2022, with an expected decline at a CAGR of approximately -8% over the next five years [4].

Key Drivers and Restraints

Drivers:

• Residual use in developing countries under limited regulation
• Demand for environmental cleanup technologies

Restraints:

• Stringent bans and safety concerns
• Availability of safer, approved alternatives
• International environmental treaties

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Future Market Projection

Environmental and Regulatory Outlook

International treaties like the Stockholm Convention continue to prioritize the elimination of lindane. While some nations may exhibit leniency, global initiatives promote phasing out all remaining use, suggesting a continued downward trend in lindane’s market presence.

Potential for Residual or Alternative Use

• Environmental remediation: Potential growth dependent on global efforts to manage old stockpiles.
• Research and Development: Investment in safer, biodegradable alternatives might influence residual demand.

Innovations and Evolving Applications

Research into biodegradable insecticides and biomimetic treatments for dermatological applications could reduce or eliminate demand for lindane, possibly rendering it a historical chemical.

Long-term Outlook

Overall, lindane’s future market appears limited, constrained by environmental and safety regulations. It may persist in niche markets for specific uses, but its role in the pharmaceutical and agrichemical sectors is expected to diminish further, aligning with global health and environmental policies.

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Key Takeaways

• Clinical Development: No significant new clinical trials are underway due to regulatory restrictions; ongoing safety assessments focus on long-term toxicity and environmental impact.
• Market Trajectory: The lindane market is in decline, primarily driven by international bans and the adoption of safer alternatives.
• Regulatory Impact: The Stockholm Convention, FDA, and EMA effectively phased out lindane use except in a limited number of jurisdictions.
• Future Outlook: The market will continue shrinking, with potential niche uses limited to environmental remediation or legacy stockpile management.
• Innovation and Sustainability: Research into alternative, safer insecticidal compounds could further diminish lindane’s market relevance, aligning with global health and environmental sustainability goals.

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FAQs

1. Why was lindane banned in many regions?
Lindane was banned due to its neurotoxic, carcinogenic, and endocrine-disrupting effects, alongside its environmental persistence and bioaccumulation, prompting global regulatory action.

2. Are there any remaining legitimate uses of lindane today?
Limited use persists mostly in certain developing countries under strict regulation or for specific veterinary applications. However, globally, its use is largely discontinued.

3. What are the primary alternatives to lindane for treating scabies and lice?
Permethrin and malathion are the most widely accepted alternatives, offering effectiveness with a better safety profile.

4. Can lindane’s environmental impact lead to future clinical trials?
While environmental concerns drive remediation efforts, clinical trials focusing on lindane’s health effects continue but are unlikely to relate directly to therapeutic development.

5. Will lindane ever return to the market?
Given its health and environmental risks, regulatory authorities are unlikely to approve its reintroduction, favoring safe, sustainable alternatives.

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References

1. U.S. Food and Drug Administration. Lindane: Drug Safety Communication. 2014.
2. WHO. Global pesticide market trends. 2018.
3. Stockholm Convention. List of Annexes. 2001.
4. MarketWatch. Chemical & Pesticide Market Analysis. 2022.