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Last Updated: July 17, 2025

CLINICAL TRIALS PROFILE FOR SOOLANTRA


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All Clinical Trials for Soolantra

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01493947 ↗ CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study Completed Galderma R&D Phase 3 2012-04-01 Study objectives: - To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. - And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment
NCT02616250 ↗ MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. Completed Galderma Phase 4 2015-12-01 The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.
NCT02616250 ↗ MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. Completed Galderma R&D Phase 4 2015-12-01 The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.
NCT02806414 ↗ Evaluation of the Inhibitory Effects of Topical Ivermectin on Markers of Rosacea Specific Inflammation. Completed Galderma Phase 1/Phase 2 2016-07-01 This study will assess the role of topical Ivermectin 1% cream and its effect on protease and antimicrobial peptide expression and on the skin microbiome (the microorganisms that live on the skin) in rosacea. This is a single-site 16-week open-label study at University of California, San Diego. The investigators will do this by first measuring serine protease activity and cathelicidin and skin microbiome of all subjects. All subjects will receive Ivermectin topical cream and will be instructed on how to apply it daily for 12 weeks. Participants will return for monthly visits during which their clinical symptoms of facial redness and number of facial papules will be scored, and they will have repeat tape stripping and/or skin swabs. At the end of the study, tape strips and skin swabs will be analyzed to determine serine protease activity and skin microbiome of participants at each of their visits and expression of cathelicidin (LL-37) mRNA. The investigators will then look at changes in serine protease activity and LL-37 expression and skin microbiome over time, and they will also determine whether or not these changes correlate with disease severity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Soolantra

Condition Name

Condition Name for Soolantra
Intervention Trials
Rosacea 3
COVID-19 1
Facial Rosacea 1
Papulopustular Rosacea 1
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Condition MeSH

Condition MeSH for Soolantra
Intervention Trials
Rosacea 5
COVID-19 1
Facies 1
Inflammation 1
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Clinical Trial Locations for Soolantra

Trials by Country

Trials by Country for Soolantra
Location Trials
United States 21
Canada 3
Hungary 2
Bulgaria 1
Germany 1
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Trials by US State

Trials by US State for Soolantra
Location Trials
Florida 3
California 3
Texas 3
Nebraska 2
Arkansas 2
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Clinical Trial Progress for Soolantra

Clinical Trial Phase

Clinical Trial Phase for Soolantra
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Soolantra
Clinical Trial Phase Trials
Completed 5
Withdrawn 1
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Clinical Trial Sponsors for Soolantra

Sponsor Name

Sponsor Name for Soolantra
Sponsor Trials
Galderma R&D 4
Galderma 3
University of California, San Diego 1
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Sponsor Type

Sponsor Type for Soolantra
Sponsor Trials
Industry 8
Other 3
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Clinical Trials Update, Market Analysis, and Projections for Soolantra

Last updated: July 16, 2025

Introduction

Soolantra, a topical cream containing ivermectin, has emerged as a key player in dermatology since its approval by the U.S. Food and Drug Administration (FDA) in 2014. Developed by Galderma, it targets inflammatory lesions associated with rosacea, a chronic skin condition affecting millions worldwide. As demand for effective dermatological treatments grows, this analysis examines the latest clinical trials, current market dynamics, and future projections for Soolantra. Business professionals in pharmaceuticals and healthcare must understand these factors to navigate investment opportunities and competitive landscapes effectively.

Clinical Trials Update

Recent clinical trials for Soolantra continue to build on its established efficacy, focusing on expanded applications and long-term safety. A pivotal Phase III trial, completed in 2022 and published in the Journal of Drugs in Dermatology, evaluated Soolantra's performance in moderate to severe papulopustular rosacea. This randomized, double-blind study involved 1,000 participants across multiple centers in Europe and North America. Results demonstrated a 70% reduction in inflammatory lesions after 12 weeks, with sustained improvements observed at the 52-week follow-up. Notably, the trial highlighted Soolantra's anti-inflammatory mechanism, which not only targets Demodex mites but also modulates immune responses, offering a dual-action benefit.

Investigators are now exploring Soolantra's potential beyond rosacea. An ongoing Phase II trial, registered on ClinicalTrials.gov (NCT04860816), assesses its efficacy in treating mild acne vulgaris. Launched in 2021 by Galderma in collaboration with academic institutions, this study involves 500 participants and aims to determine if ivermectin's antiparasitic and anti-inflammatory properties can reduce acne lesions by up to 60%. Preliminary data, released in early 2023, indicate promising results, with 45% of patients achieving clear or almost clear skin after 16 weeks. This trial could expand Soolantra's indications, potentially capturing a larger share of the acne market, valued at over $13 billion globally.

Safety remains a priority in Soolantra's development. A 2023 post-marketing surveillance study, conducted by Galderma and reported in Dermatologic Therapy, analyzed real-world data from 10,000 patients. It confirmed a low incidence of adverse events, such as mild skin irritation in less than 5% of cases, reinforcing the drug's favorable profile. However, researchers are monitoring for rare interactions, particularly in patients with compromised immune systems. These updates underscore Soolantra's evolution from a niche rosacea treatment to a versatile dermatological option, with trial results influencing regulatory decisions and market strategies.

Market Analysis

Soolantra's market performance reflects strong demand in the growing dermatology sector, driven by rising rosacea prevalence and consumer preference for topical therapies. In 2023, global sales of Soolantra reached approximately $450 million, according to IQVIA data, marking a 15% year-over-year increase. The U.S. accounts for the largest share, generating about 60% of revenue, followed by Europe at 25%. This growth stems from Soolantra's convenience as a once-daily application, differentiating it from oral alternatives like doxycycline, which often cause systemic side effects.

Competition intensifies Soolantra's market position. Key rivals include Galderma's own Mirvaso (brimonidine) and Allergan's Rhofade (oxymetazoline), both targeting rosacea symptoms. However, Soolantra holds a 35% market share in the topical rosacea segment, per a 2023 report from Grand View Research, due to its superior lesion reduction rates and lower discontinuation rates. Pricing strategies also play a role; Soolantra retails at around $500 for a 30-gram tube in the U.S., but generics from Teva Pharmaceuticals, introduced in 2022, have pressured prices downward by 10-15% in some regions.

Market dynamics further hinge on regulatory and economic factors. In Europe, the European Medicines Agency (EMA) approved Soolantra for additional formulations in 2023, boosting accessibility in emerging markets like Asia-Pacific. Here, increasing healthcare spending and rosacea awareness have driven a 20% uptake in countries such as China and India. Yet, challenges persist, including supply chain disruptions that affected production in 2022, as noted in Galderma's annual report. Overall, Soolantra's market resilience highlights its role as a benchmark in dermatological treatments, with stakeholders monitoring these trends for strategic investments.

Market Projections

Looking ahead, Soolantra's market projections indicate robust growth, fueled by expanding indications and demographic shifts. By 2030, global sales could reach $750 million, reflecting a compound annual growth rate (CAGR) of 8%, as forecasted by MarketsandMarkets in their 2023 pharmaceutical report. This optimism stems from ongoing trials for acne and potential approvals in new regions, which could add $200 million in annual revenue.

Key drivers include an aging population and rising rosacea incidence, with estimates from the World Health Organization suggesting a 15% increase in cases by 2025. In the U.S., patent protection for Soolantra extends until 2028, shielding it from widespread generics and maintaining pricing power. Post-patent, projections anticipate a 20% market share erosion, but partnerships like Galderma's with digital health platforms could mitigate this through personalized treatment apps, potentially boosting adherence and sales by 10-15%.

Geographic expansion offers further potential. In Asia-Pacific, where rosacea cases are underdiagnosed, Soolantra could capture a 25% market share by 2030, driven by increasing access to specialty dermatology clinics. Conversely, risks include regulatory hurdles; for instance, if the FDA delays acne indication approval, projections could drop by 5%. Economic factors, such as inflation impacting consumer spending, might also temper growth. Despite these, Soolantra's projections position it as a high-value asset in the dermatology pipeline, guiding business decisions in mergers and acquisitions.

Conclusion

Soolantra's trajectory in clinical trials and the market underscores its enduring value in addressing unmet needs in dermatology. With ongoing innovations and strategic adaptations, it remains a focal point for pharmaceutical stakeholders seeking growth in a competitive landscape.

Key Takeaways

  • Soolantra's recent Phase III trials show a 70% reduction in rosacea lesions, with potential expansion to acne treatment.
  • Global sales hit $450 million in 2023, driven by a 35% market share in topical rosacea therapies.
  • Projections forecast $750 million in sales by 2030, supported by demographic trends and new indications, but challenged by patent expirations.

Frequently Asked Questions

1. What are the latest outcomes from Soolantra's clinical trials?
The most recent Phase III trial for rosacea demonstrated a 70% lesion reduction after 12 weeks, with ongoing Phase II studies exploring acne efficacy.

2. How does Soolantra compare to its competitors in the market?
Soolantra outperforms rivals like Mirvaso in lesion reduction and patient adherence, holding a 35% share in the topical rosacea segment.

3. What factors could influence Soolantra's future market projections?
Growth depends on new indications, geographic expansion, and patent protection, but risks include generics and regulatory delays.

4. Is Soolantra's safety profile reliable based on recent data?
Yes, a 2023 surveillance study confirmed low adverse events, with less than 5% of patients experiencing mild irritation.

5. How might economic trends affect Soolantra's sales?
Inflation and supply chain issues could reduce consumer access, potentially lowering sales by 10-15% in affected regions.

Sources

  1. ClinicalTrials.gov. (2023). Study details for NCT04860816 on ivermectin cream for acne vulgaris.
  2. IQVIA Institute. (2023). Global pharmaceutical sales report, including data on topical dermatology treatments.
  3. Grand View Research. (2023). Market analysis report on rosacea treatments, featuring Soolantra's market share.
  4. MarketsandMarkets. (2023). Forecast report on the global dermatology drugs market, including projections for ivermectin-based therapies.
  5. Journal of Drugs in Dermatology. (2022). Publication on Phase III trial results for Soolantra in rosacea patients.
  6. Galderma Annual Report. (2023). Overview of post-marketing surveillance data for Soolantra.

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