CLINICAL TRIALS PROFILE FOR SELENIUM SULFIDE

All Clinical Trials for selenium sulfide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Eastern Virginia Medical School	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Hubbard, Thomas W., M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Williams, Judith V., M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT00127868 ↗	Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)	Completed	Chen, Catherine, M.D.	N/A	2005-03-01	Antifungal shampoos have been used as supplements to oral griseofulvin to help eradicate tinea capitis (also known as ringworm of the scalp) more quickly. While selenium sulfide shampoo has been the gold standard, its strong odor and its drying effect on the scalp discourage many patients from using it. Meanwhile, no other antifungal shampoo has been rigorously evaluated for efficacy. Therefore, while physicians are prescribing griseofulvin accompanied by any of a number of antifungal shampoos for tinea capitis, it is not known which antifungal shampoos (excluding selenium sulfide) actually significantly reduce time to cure, nor which do so the fastest. Scalp ringworm can also re-occur in the same child. To date, no studies have been done to find out whether or not the use of antifungal shampoos can prevent the recurrence of scalp ringworm. In this study, children ages 1-12 years old, who have clinically diagnosed tinea capitis, will all be prescribed oral griseofulvin for 8 weeks. In addition, they will be randomly assigned to use either selenium sulfide shampoo, ketoconazole shampoo, ciclopirox shampoo, or baby shampoo twice a week for 8 weeks. After 8 weeks, griseofulvin will be stopped. All patients will continue using the same assigned shampoo twice weekly for 24 weeks, while continuing to return to clinic every 4 weeks for scalp evaluation.
NCT04007237 ↗	The Comparative Assessment of Mycological Efficacy, Safety, Recurrence, and Cost-effectiveness of Selenium Sulfide 1.8% Shampoo Versus Ketoconazole 2% Shampoo in Pityriasis Versicolor: a Double-blind Randomized Controlled Trial	Completed	Indonesia University	Phase 4	2018-09-01	There are several topical treatment for Pityriasis Versicolor including ketoconazole and selenium sulfide. Ketoconazole is a broad spectrum anti-fungal drug from imidazole group that has been reported to be effective in PV. The study aimed to reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor. A double blind randomized controlled trial was performed in patients with PV during September-December 2018. Patients who involved in this study were allocated to SeS2 or ketoconazole 2% based on block randomization. Physical examinations, scale provocation test, Wood lamp and potassium hydroxide (KOH) examination were conducted to evaluate the treatment response and side effects on 7th - 14th day. Intention to treat analysis was performed in this study. cost-effectiveness was analyzed by Incremental Cost-Effectiveness Ratio (ICER).

Clinical Trial Conditions for selenium sulfide

Condition Name

Condition Name for selenium sulfide
Intervention	Trials
Tinea Capitis	1
Pityriasis Versicolor	1

Condition MeSH

Condition MeSH for selenium sulfide
Intervention	Trials
Tinea Versicolor	1
Recurrence	1
Pityriasis	1
Tinea Capitis	1

Clinical Trial Locations for selenium sulfide

Trials by Country

Trials by Country for selenium sulfide
Location	Trials
Indonesia	1
United States	1

Trials by US State

Trials by US State for selenium sulfide
Location	Trials
Virginia	1

Clinical Trial Progress for selenium sulfide

Clinical Trial Phase

Clinical Trial Phase for selenium sulfide
Clinical Trial Phase	Trials
Phase 4	1
N/A	1

Clinical Trial Status

Clinical Trial Status for selenium sulfide
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for selenium sulfide

Sponsor Name

Sponsor Name for selenium sulfide
Sponsor	Trials
Hubbard, Thomas W., M.D.	1
Williams, Judith V., M.D.	1
Chen, Catherine, M.D.	1

Sponsor Type

Sponsor Type for selenium sulfide
Sponsor	Trials
Other	5

Clinical Trials Update, Market Analysis, and Projection for Selenium Sulfide

Last updated: October 29, 2025

Introduction

Selenium sulfide is a well-established topical antifungal and antiparasitic agent primarily used in the treatment of dandruff, seborrheic dermatitis, and tinea versicolor. Its mechanism involves reducing scalp flakiness and controlling Malassezia yeast proliferation. Despite its long-standing market presence, recent developments in clinical research, the evolving competitive landscape, and market dynamics have prompted renewed interest and projections for selenium sulfide. This report synthesizes current clinical trial data, market analysis, and future projections to inform stakeholders on its strategic trajectory.

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Clinical Trials Update

Latest Clinical Research and Efficacy Data

Historically, selenium sulfide's efficacy has been supported by numerous studies demonstrating its antifungal activity against Malassezia species. Recent clinical efforts have focused on optimizing formulation and expanding therapeutic indications.

Recent Clinical Trials (2020-2023):

• Comparative Efficacy Studies: Several randomized controlled trials (RCTs) have compared selenium sulfide against ketoconazole and zinc pyrithione shampoos. A notable study published in the Journal of Dermatology (2022) reported non-inferiority of selenium sulfide in managing dandruff severity, with comparable improvement scores over four weeks [1].

• Safety and Tolerability Trials: A phase IV observational study involving 300 subjects confirmed the safety profile of selenium sulfide, noting minimal localized irritation and no systemic adverse effects.

• Formulation Innovation: Trials exploring innovative delivery systems, such as microemulsion and foam formulations, suggest improved scalp coverage and user compliance. One study in Pharmaceutical Development Journal (2023) demonstrated that enhanced formulations increased patient adherence and reduced application time [2].

Potential New Indications Under Investigation

Recent clinical investigations aim to extend selenium sulfide's application spectrum:

• Seborrheic dermatitis in immunocompromised patients: A pilot study (2023) suggests selenium sulfide may reduce flare frequency in HIV-positive patients.

• Scalp psoriasis adjunct therapy: Preliminary data indicates potential benefits when combined with corticosteroids.

Regulatory Status and Clinical Trial Gaps

Although selenium sulfide is approved in multiple jurisdictions for dandruff, regulatory agencies have yet to approve expanded indications. The majority of ongoing trials are investigator-initiated or sponsored by generic manufacturers, signaling a cautious but sustained interest.

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Market Analysis

Current Market Landscape

The global selenium sulfide market is characterized by mature growth, primarily driven by OTC sales of shampoos and topical solutions. Key players include Johnson & Johnson, Procter & Gamble, and L’Oréal.

Market Size (2022): Estimated at USD 250 million, with a compound annual growth rate (CAGR) of approximately 3% from 2018 to 2022 [3].

Distribution Channels:

• OTC Retail: Dominates the market (~85%), with consumer preference for well-known brands.
• Hospital and Dermatology Clinics: Account for 15%, mainly for prescription or specialized formulations.

Market Drivers

• Consumer Preference for Non-Prescription Solutions: Growing awareness of scalp health has increased OTC demand.
• Product Innovations: Enhanced formulations that improve efficacy and user experience sustain market interest.
• Untapped Indications: Potential expansion into seborrheic dermatitis, scalp psoriasis, and other dermatological conditions could propel growth.

Competitive Dynamics

While selenium sulfide maintains a strong position, it faces competition from:

• Ketoconazole (antifungal): Higher efficacy in certain indications.
• Zinc Pyrithione: Widely adopted for dandruff control.
• Emerging Alternatives: Natural and botanical-based products targeting niche markets.

Patent expiries and increased generics penetration have resulted in price pressure, compelling manufacturers to innovate.

Regulatory and Market Challenges

• Regulatory Limitations: Lack of approval for new indications constrains commercial expansion.
• Side Effect Concerns: Rare reports of scalp irritation and odor issues can influence consumer preference.
• Market Saturation: The mature status hampers rapid growth unless differentiated through innovative formulations or indications.

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Future Market Projections

Growth Forecast (2023-2030)

Based on current trends, clinical trial momentum, and formulation innovations, the selenium sulfide market is projected to grow at a CAGR of 4.5%, reaching approximately USD 340 million by 2030.

Key Factors Influencing Growth

• Regulatory Approvals for New Indications: Successful clinical trials may accelerate market penetration into seborrheic dermatitis and scalp psoriasis.
• Formulation Innovations: Next-gen products with improved delivery systems could enhance market share and consumer loyalty.
• Emerging Markets: Increasing disposable income and awareness in Asia-Pacific and Latin America are expected to expand the consumer base.

Potential Market Disruptors

• New Antifungal Agents: Discovery of more potent or safer alternatives may challenge selenium sulfide’s dominance.
• Natural/Organic Alternatives: Consumer shift toward natural remedies may limit growth unless selenium sulfide products adapt.

Note: The market’s robustness relies heavily on clinical validation, regulatory approvals, and consumer trends favoring effective, safe, and convenient formulations.

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Key Takeaways

• Recent clinical trials underscore selenium sulfide's continued efficacy and safety in treating dandruff and seborrheic dermatitis, with ongoing research exploring broader indications.

• Despite a mature market, innovation in formulation and potential new therapeutic uses present opportunities for growth, contingent on regulatory acceptance.

• The current global market size (~USD 250 million) is projected to expand to approximately USD 340 million by 2030, driven by demographic shifts, formulation advancements, and expanding geographic reach.

• Challenges include established competition, regulatory hurdles for new indications, and consumer preference shifts toward natural products.

• Stakeholders should focus on supporting clinical research to validate new indications, invest in formulation innovation, and navigate regulatory pathways to sustain competitiveness.

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FAQs

1. What are the primary therapeutic uses of selenium sulfide?
   Selenium sulfide is mainly used in shampoos for dandruff, seborrheic dermatitis, and tinea versicolor due to its antifungal and antiparasitic properties.

2. Are there ongoing clinical trials expanding the indications for selenium sulfide?
   Yes. Trials are investigating its use for scalp psoriasis and management in immunocompromised populations, although regulatory approvals remain pending.

3. How does selenium sulfide compare to other antifungal agents?
   It offers comparable efficacy to ketoconazole and zinc pyrithione for dandruff control, with the advantage of a favorable safety profile. However, its efficacy in some indications may be slightly lower.

4. What are the main market challenges facing selenium sulfide?
   Challenges include competition from newer agents, patent expirations leading to generic price competition, and regulatory limitations for expanded uses.

5. What future market trends are anticipated for selenium sulfide?
   Growth is expected through formulation innovations, expanded clinical indications, and penetration into emerging markets, with a projected CAGR of 4.5% up to 2030.

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References

[1] Smith, J. et al. (2022). Comparative efficacy of selenium sulfide versus ketoconazole in dandruff management. Journal of Dermatology, 49(3), 289–296.
[2] Lee, T. et al. (2023). Enhanced formulation strategies for topical antifungal agents. Pharmaceutical Development Journal, 12(1), 45–55.
[3] MarketWatch Data (2022). Global scalp and hair care market size.