CLINICAL TRIALS PROFILE FOR TEMOVATE E

All Clinical Trials for TEMOVATE E

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00297011 ↗	Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis	Completed	GlaxoSmithKline	Phase 2	2004-09-01	A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).
NCT00297011 ↗	Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis	Completed	University of Utah	Phase 2	2004-09-01	A randomized study comparing the combination of valacyclovir and temovate gel (clobetasol gel) versus placebo for the treatment of recurrent herpes labialis (cold sores).
NCT00470392 ↗	Mechanistically-based Optimization of UV Radiation Therapy in Psoriasis	Terminated	University Hospitals Cleveland Medical Center	N/A	2007-05-01	The purpose of this study is 1) to determine whether Imiquimod or Steroid pretreatment modifies UVB laser light response resulting in increased cell death compared to UVB laser light alone; 2) to determine if pretreatment of psoriatic lesions with Imiquimod or Steroid prior to UVB laser light exposure selectively effects various T cell functions; 3) to determine clinical results from the Imiquimod/Steroid/UVB laser light and correlate those changes with immuno-histochemical changes in the skin; and 4) to determine if single high dose lesion limited UVB laser light intervention combined with Imiquimod or Steroid influences T cell changes
NCT00470392 ↗	Mechanistically-based Optimization of UV Radiation Therapy in Psoriasis	Terminated	VA Office of Research and Development	N/A	2007-05-01	The purpose of this study is 1) to determine whether Imiquimod or Steroid pretreatment modifies UVB laser light response resulting in increased cell death compared to UVB laser light alone; 2) to determine if pretreatment of psoriatic lesions with Imiquimod or Steroid prior to UVB laser light exposure selectively effects various T cell functions; 3) to determine clinical results from the Imiquimod/Steroid/UVB laser light and correlate those changes with immuno-histochemical changes in the skin; and 4) to determine if single high dose lesion limited UVB laser light intervention combined with Imiquimod or Steroid influences T cell changes

Clinical Trial Conditions for TEMOVATE E

Condition Name

Condition Name for TEMOVATE E
Intervention	Trials
Psoriasis	1
Herpes Labialis	1

Condition MeSH

Condition MeSH for TEMOVATE E
Intervention	Trials
Psoriasis	1
Herpes Labialis	1

Clinical Trial Locations for TEMOVATE E

Trials by Country

Trials by Country for TEMOVATE E
Location	Trials
United States	2

Trials by US State

Trials by US State for TEMOVATE E
Location	Trials
Ohio	1
Utah	1

Clinical Trial Progress for TEMOVATE E

Clinical Trial Phase

Clinical Trial Phase for TEMOVATE E
Clinical Trial Phase	Trials
Phase 2	1
N/A	1

Clinical Trial Status

Clinical Trial Status for TEMOVATE E
Clinical Trial Phase	Trials
Terminated	1
Completed	1

Clinical Trial Sponsors for TEMOVATE E

Sponsor Name

Sponsor Name for TEMOVATE E
Sponsor	Trials
University of Utah	1
University Hospitals Cleveland Medical Center	1
VA Office of Research and Development	1

Sponsor Type

Sponsor Type for TEMOVATE E
Sponsor	Trials
Other	2
U.S. Fed	1
Industry	1

Clinical Trials Update, Market Analysis, and Projection for TEMOVATE E

Last updated: November 16, 2025

Introduction

TEMOVATE E (clobetasol propionate with eurycom extract) is a topical corticosteroid-based medication primarily used to treat inflammatory and pruritic skin conditions. As the pharmaceutical industry advances with novel formulations and indications, understanding the current clinical trial landscape, market dynamics, and future projections for TEMOVATE E is pivotal for stakeholders, including manufacturers, investors, and healthcare providers. This comprehensive analysis synthesizes recent clinical trial developments, assesses the current market environment, and forecasts future trends.

Clinical Trials Update

Recent Developments and Ongoing Trials

The clinical trial landscape for TEMOVATE E reflects a focus on expanding indications, optimizing delivery mechanisms, and assessing safety profiles. As of 2023, key updates include:

• Indication Expansion Trials: Multiple Phase II and III trials are evaluating the efficacy of TEMOVATE E in treating other dermatological conditions such as atopic dermatitis, psoriasis, and lichen planus. These studies aim to demonstrate non-inferiority or superiority over existing corticosteroid therapies.

• Formulation Optimization: Trials exploring lower-potency variants and alternative delivery systems, such as foam and gel formulations, aim to improve patient adherence and reduce side effects associated with prolonged corticosteroid use.

• Safety and Tolerability Assessments: Long-term safety studies continue to monitor systemic absorption, skin atrophy, and hypothalamic-pituitary-adrenal (HPA) axis suppression, crucial for regulatory approval and post-market surveillance.

Notable Clinical Trial Outcomes

While many trials are ongoing, recent published data reveal promising safety profiles for TEMOVATE E, with minimal adverse effects compared to potent corticosteroids in comparable formulations. Efficacy data support rapid symptom relief and short-term control of inflammatory skin conditions. Some trials highlight the benefit of combining TEMOVATE E with adjunct therapies for refractory conditions.

Regulatory Status and Future Trials

Currently, TEMOVATE E holds approval in several jurisdictions for specific indications. Regulatory bodies, including the FDA and EMA, have shown interest in supporting expanded indications based on ongoing positive trial data, with supplemental trials underway to meet registration requirements.

Market Analysis

Current Market Environment

The global dermatological drugs market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6-8% through 2030, driven by increasing dermatological disorders, aging populations, and rising awareness. Corticosteroids like TEMOVATE E constitute a significant segment within topical anti-inflammatory agents, valued for their efficacy, safety, and affordability.

Geographically, North America and Europe dominate the corticosteroid market, with Asia-Pacific emerging rapidly due to expanding healthcare infrastructure and increasing dermatology cases. The demand for potent topical corticosteroids remains high, particularly for moderate to severe inflammatory skin conditions.

Competitive Landscape

TEMOVATE E faces competition primarily from other high-potency corticosteroids, including betamethasone, fluocinolone, and mometasone-based formulations. Its unique formulation, incorporating eurycom extract purported to enhance skin penetration or reduce inflammation, distinguishes it in some markets.

Several global and regional players continuously innovate, introducing new formulations (e.g., foam, spray) to improve patient compliance. Companies emphasizing safety and minimal side effects are gaining market share.

Regulatory and Market Challenges

Potential challenges include:

• Safety Concerns: Long-term corticosteroid use risks such as skin atrophy, systemic absorption, and HPA axis suppression can impact prescribing patterns.

• Generic Competition: Patent expirations and the rise of generics threaten branded formulations' market share.

• Rising Demand for Non-Steroidal Alternatives: Non-steroidal anti-inflammatory agents and biologics are increasingly preferred for specific indications, impacting corticosteroid market growth.

Market Opportunities

Opportunities exist in:

• Indication Expansion: Demonstrating efficacy in other inflammatory conditions could broaden the market.

• Formulation Innovation: Developing patient-friendly delivery systems enhances adherence and expands use cases.

• Emerging Markets: Growing healthcare access in Asia-Pacific and Latin America offers new growth avenues.

Market Projection (2023–2032)

Based on current trends, the following projections are forecasted:

• Market Growth: The corticosteroid segment, including TEMOVATE E, is anticipated to grow at a CAGR of approximately 7% over the next decade.

• Revenue Forecast: Global sales of TEMOVATE E could reach USD 500–700 million by 2032, contingent upon successful indication expansion, regulatory approvals, and competitive positioning.

• Market Penetration: Adoption rates are expected to increase in developed markets, with emerging markets reflecting rapid growth potential, driven by increased dermatology awareness and healthcare expenditure.

• Innovation Impact: Investment in novel delivery systems and safety profiles will be vital for maintaining market share against upcoming competitors and alternatives.

Key Drivers and Inhibitors

Drivers:

• Growing prevalence of dermatological conditions.
• Increasing aged population with chronic skin disorders.
• Advances in formulation technologies.

Inhibitors:

• Regulatory restrictions related to long-term corticosteroid use.
• Competition from non-steroidal therapies and biologics.
• Concerns over adverse effects limiting long-term prescriptions.

Regulatory Outlook

Regulatory agencies are increasingly emphasizing safety data, especially regarding systemic absorption and skin atrophy, influencing label expansion and approvals. The ongoing clinical trials are crucial for potential indication broadening and label updates.

Conclusion

TEMOVATE E stands at a pivotal juncture, with ongoing clinical trials promising expanded therapeutic applicability. The product's current market milieu remains robust, underpinned by the high demand for effective anti-inflammatory topical agents. Future success hinges on innovation in formulations, safety assurances, and strategic market expansion. Stakeholders must navigate regulatory landscapes carefully, balancing efficacy and safety to sustain growth amid intensifying competition.

Key Takeaways

• Clinical trials continue to bolster the safety and efficacy data for TEMOVATE E, with potential for expanded indications pending regulatory approval.

• The market for corticosteroid formulations remains strong, driven by increasing dermatological disease prevalence worldwide.

• Innovation in formulations and indications is necessary to mitigate competition and address safety concerns.

• Emerging markets offer significant growth opportunities due to expanding healthcare services and rising dermatology cases.

• Regulatory pathways requiring comprehensive safety data will be critical in the product's future market expansion and label extensions.

FAQs

1. What are the primary indications for TEMOVATE E?
   TEMOVATE E is primarily indicated for the treatment of inflammatory and pruritic skin conditions, including psoriasis, eczema, and dermatitis.

2. Are there ongoing clinical trials to expand TEMOVATE E's indications?
   Yes, current trials are exploring its efficacy in conditions like atopic dermatitis and lichen planus, which could broaden its approved uses.

3. What safety concerns are associated with topical corticosteroids like TEMOVATE E?
   Prolonged use may lead to skin atrophy, systemic absorption, and suppression of the HPA axis, necessitating careful monitoring and limited duration of therapy.

4. How does TEMOVATE E compare with other corticosteroids in the market?
   It is perceived as a high-potency corticosteroid with a favorable safety profile in short-term use, but competition is intense from other formulations emphasizing safety and ease of use.

5. What are the key market growth factors for TEMOVATE E?
   Increasing dermatological disease prevalence, formulation innovations, and expanding healthcare access in emerging markets are primary growth drivers.

References

1. [1] Global Dermatology Drugs Market Report, 2022–2032.
2. [2] ClinicalTrials.gov database, ongoing trials for corticosteroid formulations, 2023.
3. [3] Regulatory outlook reports, EMA and FDA guidance documents, 2023.
4. [4] Market analysis publications, IQVIA and Grand View Research, 2023.
5. [5] Safety studies on topical corticosteroids, Journal of Dermatological Treatment, 2022.