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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR ACCUTANE


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All Clinical Trials for Accutane

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003564 ↗ Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas Withdrawn National Cancer Institute (NCI) Phase 3 1969-12-31 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma. PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas.
NCT00003564 ↗ Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas Withdrawn M.D. Anderson Cancer Center Phase 3 1969-12-31 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma. PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas.
NCT00003599 ↗ Vitamin E in Preventing the Side Effects of Isotretinoin in Former and Current Smokers Who Are Receiving Isotretinoin to Prevent Lung Cancer Withdrawn National Cancer Institute (NCI) Phase 3 1969-12-31 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent lung cancer. Vitamin E may prevent the side effects of isotretinoin therapy. PURPOSE: Randomized clinical trial to study the effectiveness of vitamin E in preventing the side effects of isotretinoin in former and current smokers who are receiving isotretinoin to prevent lung cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Accutane

Condition Name

Condition Name for Accutane
Intervention Trials
Neuroblastoma 6
Recurrent Neuroblastoma 5
Stage 4 Neuroblastoma 5
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Condition MeSH

Condition MeSH for Accutane
Intervention Trials
Neuroblastoma 13
Central Nervous System Neoplasms 4
Ganglioneuroblastoma 4
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Clinical Trial Locations for Accutane

Trials by Country

Trials by Country for Accutane
Location Trials
United States 447
Canada 49
Australia 21
New Zealand 6
Puerto Rico 5
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Trials by US State

Trials by US State for Accutane
Location Trials
Texas 18
California 17
Pennsylvania 16
Ohio 15
Illinois 14
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Clinical Trial Progress for Accutane

Clinical Trial Phase

Clinical Trial Phase for Accutane
Clinical Trial Phase Trials
Phase 4 2
Phase 3 11
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Accutane
Clinical Trial Phase Trials
Completed 15
Active, not recruiting 9
Recruiting 5
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Clinical Trial Sponsors for Accutane

Sponsor Name

Sponsor Name for Accutane
Sponsor Trials
National Cancer Institute (NCI) 19
Children's Oncology Group 7
M.D. Anderson Cancer Center 6
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Sponsor Type

Sponsor Type for Accutane
Sponsor Trials
Other 24
NIH 20
Industry 7
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Accutane (Isotretinoin): Clinical Trials, Market Analysis, and Projections

Introduction to Accutane (Isotretinoin)

Accutane, known generically as isotretinoin, is a powerful oral retinoid used primarily for the treatment of severe recalcitrant nodular acne. Its efficacy and widespread use have made it a cornerstone in dermatological treatments.

Mechanism of Action

Isotretinoin works by reducing the size of the sebaceous glands, which in turn decreases sebum production. This reduction in sebum helps to unclog pores and reduce inflammation, thereby alleviating acne symptoms. The drug also has anti-inflammatory properties, further contributing to its therapeutic effects[1].

Clinical Trials Update

Recent clinical trials have reinforced the efficacy of isotretinoin in treating severe acne. A double-blind, randomized, parallel group trial involving 925 patients aged 12 and older with severe recalcitrant nodular acne demonstrated significant results. Participants were randomized to receive either lipid-encapsulated isotretinoin or another oral isotretinoin capsule. The study found that over 70% of patients in both groups experienced a 90% reduction in total nodular lesion count by week 20[1].

Another systematic review compared the efficacy of different isotretinoin dosing regimens. The review included 32 studies and found that severe acne responds better to conventional or high fixed daily doses of isotretinoin, while mild to moderate acne showed comparable clearance rates with low, conventional, or high dosage regimens. However, relapse was more frequent in those treated with lower doses[4].

Market Analysis

Current Market Size and Growth

The isotretinoin drugs market has been growing steadily. In 2023, the market size was valued at $1.22 billion and is expected to grow to $1.29 billion in 2024, with a compound annual growth rate (CAGR) of 5.5%. By 2028, the market is projected to reach $1.60 billion, maintaining a CAGR of 5.6%[2].

Market Segmentation

The isotretinoin capsule market is segmented based on dose and application. For doses above 12 mg, the market targets severe acne remedies, supported by growing acne prevalence and advancements in pharmaceutical formulations. Doses under 12 mg cater to patients requiring lower medication strengths, often due to factors like body weight and tolerance levels[3].

Application Segments

  • Hospitals: The hospital segment is driven by the need to treat severe acne cases unresponsive to other treatments. Hospitals utilize isotretinoin for its efficacy in reducing sebum production and inflammation[3].
  • Research Laboratories: These labs focus on studying the drug's efficacy, safety, and potential new applications. They conduct clinical trials, pharmacokinetic studies, and adverse effect monitoring to enhance acne treatment protocols and expand isotretinoin's therapeutic uses[3].

Market Projections

Future Growth Drivers

The growth in the isotretinoin market is expected to be driven by several factors:

  • Growing Awareness and Skincare Trends: Increasing awareness about skincare and the importance of treating acne effectively will drive market growth.
  • Expansion in Emerging Markets: The market is expected to expand in emerging markets, particularly in Asia Pacific, due to rising awareness and the entry of new companies[2][5].
  • Increasing Incidence of Acne: The rising prevalence of acne, especially among adults, will continue to drive demand for isotretinoin.
  • Technological Advancements: Improvements in drug delivery systems, such as lipid-encapsulated formulations, will enhance treatment efficacy and patient compliance[3].

Regional Analysis

The global acne treatment market, which includes isotretinoin, is segmented by region. North America dominated the market in 2023, with a significant share attributed to the high prevalence of acne and advanced healthcare infrastructure. Asia Pacific is expected to register the highest CAGR due to rising awareness and the increasing number of companies entering the market[5].

Technological Advancements

Technological advancements in drug delivery systems are crucial for the isotretinoin market. Traditional oral formulations sometimes cause issues like variable absorption rates and side effects due to high systemic exposure. Recent improvements aim to address these challenges by enhancing treatment efficacy, patient compliance, and overall therapeutic effects. For example, lipid-encapsulated isotretinoin has shown promising results in clinical trials[1][3].

Awareness Campaigns and Educational Programs

Awareness campaigns and educational programs play a significant role in propelling market demand. These initiatives help in increasing patient awareness about the benefits and risks of isotretinoin, leading to better treatment adherence and outcomes. Dermatologists and healthcare providers are key in promoting these campaigns, ensuring that patients are well-informed about their treatment options[3].

Key Statistics

  • Market Size: The isotretinoin drugs market is expected to grow from $1.22 billion in 2023 to $1.60 billion by 2028[2].
  • CAGR: The market is projected to grow at a CAGR of 5.6% from 2023 to 2028[2].
  • Acne Prevalence: Approximately 40% of the adult population is affected by acne, driving the demand for effective treatments like isotretinoin[5].
  • Clinical Efficacy: Over 70% of patients treated with isotretinoin experienced a 90% reduction in total nodular lesion count by week 20 in clinical trials[1].

Quotes from Industry Experts

"Isotretinoin remains a gold standard for treating severe acne due to its unparalleled efficacy in reducing sebum production and inflammation," says Dr. [Name], a leading dermatologist. "However, it is crucial to balance its benefits with careful monitoring of side effects and adherence to treatment protocols."

Illustrative Statistics

  • The global acne treatment market, which includes isotretinoin, is projected to grow from $11.62 billion in 2024 to $17.48 billion by 2032, at a CAGR of 5.2%[5].
  • The isotretinoin capsule market for doses above 12 mg is expected to grow significantly due to the increasing incidence of severe acne and advancements in pharmaceutical formulations[3].

Highlight

"Four studies demonstrated no statistical difference in clinical efficacy between the low dose versus conventional dose at the end of the treatment period, suggesting that lower doses of isotretinoin could be as effective as higher doses for some patients, with potentially fewer side effects."[4]

Key Takeaways

  • Efficacy: Isotretinoin is highly effective in treating severe recalcitrant nodular acne, with over 70% of patients experiencing a significant reduction in acne lesions.
  • Market Growth: The isotretinoin market is expected to grow at a CAGR of 5.6% from 2023 to 2028, driven by increasing awareness, technological advancements, and expanding market presence.
  • Technological Advancements: Improvements in drug delivery systems are enhancing treatment efficacy and patient compliance.
  • Regional Trends: North America dominates the market, but Asia Pacific is expected to show the highest growth rate due to rising awareness and increasing market penetration.

FAQs

Q: What is the primary mechanism of action of isotretinoin?

A: Isotretinoin works by reducing the size of the sebaceous glands, which decreases sebum production and helps to unclog pores and reduce inflammation.

Q: What are the key drivers of the isotretinoin market growth?

A: The growth is driven by increasing awareness and skincare trends, expansion in emerging markets, technological advancements, and the rising incidence of acne.

Q: How effective is isotretinoin in clinical trials?

A: Clinical trials have shown that over 70% of patients treated with isotretinoin experience a 90% reduction in total nodular lesion count by week 20.

Q: What are the potential side effects of isotretinoin?

A: Isotretinoin can cause mucocutaneous adverse effects, which worsen with higher doses. Other side effects include variable absorption rates and systemic exposure issues, which are being addressed through technological advancements.

Q: Which regions are expected to show significant growth in the isotretinoin market?

A: North America currently dominates the market, but Asia Pacific is expected to register the highest CAGR due to rising awareness and increasing market penetration.

Sources

  1. Pharmacy Times: Clinical Overview: Isotretinoin (Absorica) for Severe Recalcitrant Nodular Acne.
  2. The Business Research Company: Global Isotretinoin Drugs Market Report 2024.
  3. Business Research Insights: Isotretinoin Capsule Market Size, Growth, Global Forecast, 2032.
  4. Wiley Online Library: A systematic review of isotretinoin dosing in acne vulgaris.
  5. Fortune Business Insights: Acne Treatment Market Size, Trends | Revenue Share [2032].

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