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Last Updated: January 9, 2025

CLINICAL TRIALS PROFILE FOR DOCOSANOL


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All Clinical Trials for DOCOSANOL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03977792 ↗ An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis Not yet recruiting Ecogene 21 Phase 2 2020-09-01 BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.
NCT03977792 ↗ An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis Not yet recruiting Laboratoire Boreaderme Inc. Phase 2 2020-09-01 BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for DOCOSANOL

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Recurrent Herpes Labialis[disabled in preview]
Condition Name for DOCOSANOL
Intervention Trials
Recurrent Herpes Labialis 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Herpes Labialis[disabled in preview]
Condition MeSH for DOCOSANOL
Intervention Trials
Herpes Labialis 1
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Clinical Trial Progress for DOCOSANOL

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 2[disabled in preview]
Clinical Trial Phase for DOCOSANOL
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Not yet recruiting[disabled in preview]
Clinical Trial Status for DOCOSANOL
Clinical Trial Phase Trials
Not yet recruiting 1
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Clinical Trial Sponsors for DOCOSANOL

Sponsor Name

trials000001111111Ecogene 21Laboratoire Boreaderme Inc.[disabled in preview]
Sponsor Name for DOCOSANOL
Sponsor Trials
Ecogene 21 1
Laboratoire Boreaderme Inc. 1
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Sponsor Type

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1OtherIndustry[disabled in preview]
Sponsor Type for DOCOSANOL
Sponsor Trials
Other 1
Industry 1
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DOCOSANOL Market Analysis and Financial Projection

Docosanol: Clinical Efficacy, Market Analysis, and Projections

Clinical Efficacy of Docosanol

Background and Objective

Docosanol, a saturated monofatty alcohol, has been studied extensively for its efficacy in treating recurrent herpes simplex labialis (HSL), a condition affecting 20% to 40% of the US population. The primary objective of clinical trials was to determine whether docosanol 10% cream is effective compared to a placebo in treating episodes of acute HSL[1].

Clinical Trials

Two identical double-blind, placebo-controlled studies were conducted at 21 sites. Healthy adults with documented histories of HSL were randomized to receive either docosanol 10% cream or a polyethylene glycol placebo. Treatment was initiated in the prodrome or erythema stage and administered five times daily until healing occurred.

Results

The clinical trials showed significant results in favor of docosanol:

  • The median time to healing in the docosanol group was 4.1 days, which was 18 hours shorter than in the placebo group (P = .008)[1].
  • Docosanol reduced the time to cessation of pain and other symptoms (itching, burning, and tingling) by 3 to 16.5 hours (P = .002)[1].
  • It also reduced the time to complete healing of classic lesions and the cessation of the ulcer or soft crust stage of classic lesions (P < .001)[1].
  • Adverse experiences with docosanol were mild and similar to those with the placebo[1].

Safety and Efficacy

Docosanol applied five times daily is safe and effective in treating recurrent HSL. The differences in healing time compared favorably with other approved treatments for HSL[1].

Market Analysis

Current Market Size and Growth

The global docosanol cream market is experiencing significant growth driven by its applications in treating cold sores and fever blisters. As of 2023, the market is projected to expand substantially over the forecast period from 2023 to 2031. The market size is expected to grow at a remarkable CAGR, with the global herpes market, which includes docosanol, projected to reach USD 2.06 billion by 2031 from USD 1.24 billion in 2023, growing at a CAGR of 6.6%[3].

Market Segmentation

The docosanol cream market is segmented based on type (online and offline), application (cold sores and fever blisters), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The online segment is projected to record a significant CAGR, while the offline segment is also expected to grow steadily over the next seven years[5].

Key Drivers and Restraints

The market is driven by the increasing demand for effective treatments for cold sores and fever blisters. However, factors such as competition from other antiviral treatments and regulatory challenges can act as restraints. The COVID-19 pandemic has highlighted the importance of agile pharmaceutical companies and robust supply chain management, further emphasizing the need for effective treatments like docosanol[5].

Regional Outlook

The market dynamics vary across different regions. North America and Europe are significant markets due to high awareness and demand for antiviral treatments. The Asia-Pacific region is also expected to show substantial growth due to increasing healthcare expenditure and awareness about herpes treatments[2].

Market Projections

Future Development Prospects

The global docosanol cream market is poised for noteworthy and impactful development. Projections indicate a sustained and significant expansion from 2023 to 2031. The market is expected to reach a substantial value in USD million by 2029, growing at a CAGR from 2023 to 2029[5].

Emerging Opportunities

The market presents several emerging opportunities, particularly in the online segment, which is expected to record a high CAGR. The increasing use of online pharmacies and the growing demand for over-the-counter (OTC) antiviral treatments are key drivers of this growth[5].

Key Players

Key companies in the docosanol cream market include Aleorderm, Glaxo Smith Kline, Jenson Pharmaceutical Services, and PL Developments. These companies are profiled based on their company details, products portfolio, sales data, market share, and ranking[5].

Conclusion

Docosanol has proven its clinical efficacy in treating recurrent herpes simplex labialis, reducing healing times and symptom duration. The market for docosanol cream is expected to grow significantly over the next few years, driven by increasing demand for effective antiviral treatments. As the global healthcare landscape continues to evolve, docosanol is positioned to remain a key player in the treatment of herpes-related conditions.

Key Takeaways

  • Clinical Efficacy: Docosanol 10% cream is safe and effective in treating recurrent HSL, reducing healing times and symptom duration.
  • Market Growth: The global docosanol cream market is expected to grow at a remarkable CAGR from 2023 to 2031.
  • Market Segmentation: The market is segmented by type, application, and geographical regions.
  • Key Drivers: Increasing demand for antiviral treatments and the growing online pharmacy segment.
  • Regional Outlook: Significant growth expected in North America, Europe, and the Asia-Pacific region.

FAQs

What is docosanol used for?

Docosanol is used for the treatment of recurrent herpes simplex labialis (HSL), commonly known as cold sores or fever blisters.

How effective is docosanol in treating HSL?

Docosanol has been shown to reduce the median time to healing by 18 hours compared to a placebo and also reduces the time to cessation of pain and other symptoms[1].

What are the key drivers of the docosanol cream market?

The key drivers include increasing demand for effective antiviral treatments and the growing online pharmacy segment[5].

Which regions are expected to show significant growth in the docosanol cream market?

North America, Europe, and the Asia-Pacific region are expected to show substantial growth due to high awareness and increasing healthcare expenditure[2].

Who are the key players in the docosanol cream market?

Key players include Aleorderm, Glaxo Smith Kline, Jenson Pharmaceutical Services, and PL Developments[5].

Sources

  1. Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: PubMed.
  2. Global Docosanol Cream Market Size, Trends and Projections: Market Research Intellect.
  3. Herpes Market Size, Statistics, Scope & Trends Analysis By 2031: Data Bridge Market Research.
  4. Docosanol – Knowledge and References: Taylor & Francis.
  5. Docosanol Cream - Global Market Insights and Sales Trends 2024: QY Research.

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