CLINICAL TRIALS PROFILE FOR ISOTRETINOIN

All Clinical Trials for Isotretinoin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000764 ↗	Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.	Completed	Hoffmann-La Roche	Phase 1	1969-12-31	PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.
NCT00000764 ↗	Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection.	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states.
NCT00001073 ↗	Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous. Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected women are at a greater risk, and often their tumors become cancerous more quickly than those in HIV-negative women. Isotretinoin may be able to prevent this from happening. However, since these tumors tend to disappear over time, many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects. This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves.
NCT00002506 ↗	Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer	Completed	Cancer Biotherapy Research Group	Phase 2	1992-08-01	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 cancer or stop cancer from growing. Interferon alfa may interfere with the growth of cancer cells. Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers. PURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer.
NCT00002506 ↗	Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer	Completed	Hoag Memorial Hospital Presbyterian	Phase 2	1992-08-01	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 cancer or stop cancer from growing. Interferon alfa may interfere with the growth of cancer cells. Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers. PURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer.
NCT00002737 ↗	Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1996-03-01	RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the growth of kidney cancer. Isotretinoin may help kidney cancer cells develop into normal cells. It is not yet known whether interferon alfa plus isotretinoin is more effective than interferon alfa alone for kidney cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without isotretinoin in treating patients who have metastatic kidney cancer.

Clinical Trial Conditions for Isotretinoin

Condition Name

Condition Name for Isotretinoin
Intervention	Trials
Neuroblastoma	28
Acne Vulgaris	16
Acne	10
Recurrent Neuroblastoma	8

Condition MeSH

Condition MeSH for Isotretinoin
Intervention	Trials
Neuroblastoma	40
Acne Vulgaris	25
Leukemia	7
COVID-19	7

Clinical Trial Locations for Isotretinoin

Trials by Country

Trials by Country for Isotretinoin
Location	Trials
United States	690
Canada	61
Australia	28
United Kingdom	11
Egypt	9

Trials by US State

Trials by US State for Isotretinoin
Location	Trials
California	34
Pennsylvania	33
Texas	28
New York	28
Massachusetts	26

Clinical Trial Progress for Isotretinoin

Clinical Trial Phase

Clinical Trial Phase for Isotretinoin
Clinical Trial Phase	Trials
Phase 4	22
Phase 3	27
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Isotretinoin
Clinical Trial Phase	Trials
Completed	72
Not yet recruiting	18
Recruiting	15

Clinical Trial Sponsors for Isotretinoin

Sponsor Name

Sponsor Name for Isotretinoin
Sponsor	Trials
National Cancer Institute (NCI)	39
Children's Oncology Group	11
M.D. Anderson Cancer Center	7

Sponsor Type

Sponsor Type for Isotretinoin
Sponsor	Trials
Other	161
NIH	46
Industry	35

Isotretinoin: Clinical Trials, Market Analysis, and Projections

Introduction to Isotretinoin

Isotretinoin, a derivative of vitamin A, is a potent medication primarily used to treat severe recalcitrant nodular acne that has not responded to other treatments. Its efficacy and widespread use have made it a significant player in the dermatological treatment market.

Clinical Trials and Efficacy

Recent clinical trials have reaffirmed the efficacy of isotretinoin in treating severe acne. A double-blind, randomized, parallel group trial involving 925 patients with severe recalcitrant nodular acne demonstrated the effectiveness of lipid-encapsulated isotretinoin compared to another oral isotretinoin formulation. The study showed that over 70% of patients in both groups experienced a 90% reduction in total nodular lesion count by the 20th week of treatment[1].

Mechanism of Action and Side Effects

Isotretinoin works by reducing sebum production and promoting skin renewal, leading to clearer and healthier skin. However, it is associated with significant side effects, including a high risk of embryo-fetal toxicity, which necessitates its use only through the iPLEDGE risk evaluation and mitigation strategy (REMS) to prevent use in pregnancy. Other notable side effects include psychiatric disturbances such as suicidal ideation, and the risk of severe skin reactions like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)[1].

New Safety Measures

To strengthen the safety of isotretinoin treatment, the Isotretinoin Expert Working Group of the Commission on Human Medicines has recommended several new measures. These include additional oversight on the initiation of treatment for patients under 18 years, consistent monitoring requirements for psychiatric and sexual side effects, and new warnings for the risk of sexual dysfunction. Patients must be fully informed about the potential benefits and risks, and healthcare professionals are advised to closely monitor patients for any side effects throughout treatment[4].

Market Analysis

Current Market Size and Growth

The global isotretinoin capsule market has seen robust growth in recent years. As of 2024, the market size was valued at approximately USD 1.29 billion, with a compound annual growth rate (CAGR) of 5.5% from the previous year. This growth is attributed to the prevalence of severe acne, the effectiveness of isotretinoin, and increased dermatology visits[5].

Forecast and Projections

The isotretinoin drugs market is projected to continue its strong growth, reaching USD 1.60 billion by 2028 at a CAGR of 5.6%. Key drivers of this growth include growing awareness and skincare trends, expansion in emerging markets, increasing incidence of acne, an aging population, and a focus on mental health and well-being[5].

Regional Market Analysis

North America is currently the largest region in the isotretinoin drugs market, followed by other regions such as Asia-Pacific, Western Europe, Eastern Europe, South America, the Middle East, and Africa. The market is expected to see significant growth in these regions due to increasing demand for effective dermatological treatments[5].

Segment Market Analysis

The isotretinoin market is segmented by type and application. Hospitals are a major segment, where isotretinoin is used to treat severe acne cases unresponsive to other treatments. Research laboratories also play a crucial role in studying the drug's efficacy, safety, and potential new applications, which helps in advancing dermatological research and improving patient outcomes[3].

Technological Advancements

Technological advancements in drug delivery systems are expected to significantly impact the isotretinoin market. Improvements in drug delivery aim to address issues such as variable absorption rates and side effects due to high systemic exposure. New formulations, such as lipid-encapsulated isotretinoin, are being developed to enhance treatment efficacy, patient compliance, and overall therapeutic effects[3].

Awareness Campaigns and Educational Programs

Awareness campaigns and educational programs are crucial in propelling market demand for isotretinoin. These initiatives help in educating both healthcare professionals and patients about the benefits and risks associated with isotretinoin treatment, thereby increasing its adoption and ensuring safer use[3].

Competitive Landscape

The isotretinoin market is competitive, with several leading players involved in the development, marketing, and distribution of the drug. The market report provides insights into the sales, price, revenue, gross margin, product profile, and application of these major players, helping companies to strategize and tap into segments with the highest growth potential[2].

Key Takeaways

• Efficacy and Clinical Trials: Isotretinoin has been proven effective in treating severe recalcitrant nodular acne through clinical trials.
• Safety Measures: New safety measures are being implemented to monitor and mitigate side effects, especially in patients under 18 years.
• Market Growth: The global isotretinoin market is projected to grow significantly, driven by increasing demand and technological advancements.
• Regional Analysis: North America leads the market, but other regions are also expected to see substantial growth.
• Technological Advancements: Improvements in drug delivery systems are expected to enhance treatment efficacy and patient compliance.

FAQs

What are the primary uses of isotretinoin?

Isotretinoin is primarily used to treat severe recalcitrant nodular acne that has not responded to other treatments.

What are the significant side effects of isotretinoin?

Isotretinoin is associated with a high risk of embryo-fetal toxicity, psychiatric disturbances such as suicidal ideation, and severe skin reactions like SJS and TEN.

What new safety measures are being implemented for isotretinoin?

New measures include additional oversight on the initiation of treatment for patients under 18 years, consistent monitoring for psychiatric and sexual side effects, and new warnings for the risk of sexual dysfunction.

What is the projected growth of the isotretinoin market?

The isotretinoin market is projected to reach USD 1.60 billion by 2028 at a CAGR of 5.6%.

Which region leads the isotretinoin market?

North America is currently the largest region in the isotretinoin drugs market.

Sources

1. Pharmacy Times: Clinical Overview: Isotretinoin (Absorica) for Severe Recalcitrant Nodular Acne.
2. Market Intelligence: Isotretinoin Capsule Market 2024: Growth Drivers and Opportunities Forecast Through 2032.
3. Business Research Insights: Isotretinoin Capsule Market Size, Growth, Global Forecast, 2032.
4. GOV.UK: Isotretinoin (Roaccutane): new safety measures to be introduced in the coming months.
5. EIN Presswire: Isotretinoin Drugs Global Market 2024 To Reach $1.60 Billion By 2028 At Rate Of 5.6%.