CLINICAL TRIALS PROFILE FOR IMIQUIMOD

All Clinical Trials for imiquimod

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00031759 ↗	Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia	Completed	National Cancer Institute (NCI)	Phase 2	1999-06-01	RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development of cancer. Applying topical imiquimod before abnormal cervical cells are removed may be effective in preventing cervical cancer. PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod before abnormal cervical cells are removed in preventing cervical cancer in patients who have recurrent or persistent cervical neoplasia.
NCT00031759 ↗	Imiquimod in Preventing Cervical Cancer in Women With Cervical Neoplasia	Completed	Alliance for Clinical Trials in Oncology	Phase 2	1999-06-01	RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development of cancer. Applying topical imiquimod before abnormal cervical cells are removed may be effective in preventing cervical cancer. PURPOSE: Randomized phase II trial to study the effectiveness of applying topical imiquimod before abnormal cervical cells are removed in preventing cervical cancer in patients who have recurrent or persistent cervical neoplasia.
NCT00066872 ↗	Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer	Completed	Queen's Medical Centre	Phase 3	2002-10-01	RATIONALE: Biological therapies such as imiquimod use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known if topical imiquimod is more effective than surgery in treating basal cell skin cancer. PURPOSE: This randomized phase III trial is studying how well topical imiquimod works compared to surgery in treating patients with basal cell skin cancer.
NCT00079300 ↗	Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer	Completed	National Naval Medical Center	Phase 1	2004-01-01	RATIONALE: Biological therapies, such as imiquimod cream, work in different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This randomized phase I trial is studying how well imiquimod cream works in treating patients with basal cell skin cancer.
NCT00110682 ↗	Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses	Completed	3M	Phase 4	2005-04-01	Study Aims: - To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy. - To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups. Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.
NCT00110682 ↗	Study of Imiquimod 5% Cream in Addition to Cryotherapy in the Management of Actinic Keratoses	Completed	Derm Research @ 888 Inc.	Phase 4	2005-04-01	Study Aims: - To compare the long-term efficacy and safety of imiquimod versus vehicle used as an adjunct to cryotherapy. - To assess and compare the recurrence rate and time to recurrence of the 2 different treatment groups. Hypothesis: The imiquimod arm will produce a more prolonged clearing of Actinic Keratoses (AK) compared to the vehicle arm.

Clinical Trial Conditions for imiquimod

Condition Name

Condition Name for imiquimod
Intervention	Trials
Actinic Keratosis	20
Actinic Keratoses	11
Cervical Intraepithelial Neoplasia	7
Basal Cell Carcinoma	7

Condition MeSH

Condition MeSH for imiquimod
Intervention	Trials
Keratosis	36
Keratosis, Actinic	36
Carcinoma	20
Carcinoma, Basal Cell	17

Clinical Trial Locations for imiquimod

Trials by Country

Trials by Country for imiquimod
Location	Trials
United States	315
United Kingdom	20
Germany	12
Netherlands	12
Austria	12

Trials by US State

Trials by US State for imiquimod
Location	Trials
Florida	22
New York	21
California	19
Texas	17
North Carolina	15

Clinical Trial Progress for imiquimod

Clinical Trial Phase

Clinical Trial Phase for imiquimod
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	35
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for imiquimod
Clinical Trial Phase	Trials
Completed	88
Recruiting	23
Terminated	17

Clinical Trial Sponsors for imiquimod

Sponsor Name

Sponsor Name for imiquimod
Sponsor	Trials
National Cancer Institute (NCI)	18
Graceway Pharmaceuticals, LLC	16
MEDA Pharma GmbH & Co. KG	11

Sponsor Type

Sponsor Type for imiquimod
Sponsor	Trials
Other	186
Industry	78
NIH	20

Imiquimod Market Analysis and Financial Projection

Imiquimod: Clinical Trials, Market Analysis, and Projections

Introduction to Imiquimod

Imiquimod is a topical cream that has been widely used in the treatment of various skin conditions, including basal cell carcinoma, actinic keratosis, and genital warts. It functions by stimulating the body's immune system to produce natural substances that fight these conditions.

Clinical Trials and Applications

Current Clinical Uses

Imiquimod is approved for the treatment of basal cell carcinoma, actinic keratosis, and genital warts. It is also used off-label for several other skin conditions, including molluscum contagiosum, herpes simplex virus (HSV), and human papillomavirus (HPV) infections[3][4].

Ongoing and Recent Clinical Trials

In recent years, imiquimod has been explored for its potential in treating other types of cancer. For instance, it has been applied in preclinical models and a phase II clinical trial for cutaneous breast cancer. This trial involved applying 5% imiquimod cream five days a week for eight weeks to patients with breast cancer skin metastases. The results showed that the treatment was well-tolerated with limited side effects, and partial responses were observed in two patients[3].

Mechanism of Action

Imiquimod works as a toll-like receptor 7 agonist, inducing cytokine production and recruiting an immune response to target and remove pathogens or lesions. This immunomodulatory role has made it a versatile treatment option for various cutaneous diseases[3].

Market Analysis

Market Size and Growth

The genital warts treatment market, where imiquimod is a leading drug, is expected to grow significantly. By 2033, the market size is projected to reach USD 2,891.9 million from USD 1,792.4 million in 2023, growing at a CAGR of 4.9% during the forecast period from 2024 to 2033[2].

Market Share and Dominance

Imiquimod holds a significant market share in the treatment of genital warts, with approximately 38% of the market. In the actinic keratosis treatment market, prescription medications like imiquimod, fluorouracil, and ingenol mebutate dominate, with the prescription segment expected to continue its dominance with a CAGR of 4.3% during the forecast period[2][5].

Distribution Channels

Hospital pharmacies currently hold the largest market share in the distribution of imiquimod and other genital warts treatments, accounting for about 49% of the market. Retail and online pharmacies also play significant roles in the distribution[2].

Regional Analysis

Global Market Distribution

North America dominates the global genital warts treatment market with a 38% market share. Europe is expected to be the fastest-growing market, while other regions such as Asia-Pacific, South America, and the Middle East and Africa also contribute significantly to the global market[2].

Side Effects and Safety

Common and Rare Side Effects

Imiquimod treatment can result in various side effects, ranging from common to rare. Common side effects include skin itching, redness, and rash, affecting more than 10% of patients. Occasional side effects include small bumps on the skin, swollen lymph nodes, and back pain, affecting between 1 and 10% of patients. Rare side effects, occurring in fewer than 1% of patients, include mood changes, nausea, dry mouth, and flu-like symptoms[1].

Coping with Side Effects

Patients are advised to report any severe or worsening side effects to their healthcare team promptly. Early treatment can help manage side effects more effectively. Additionally, patients should avoid using other medications without consulting their doctor, as imiquimod can interact with other drugs and herbal products[1].

Contraception, Pregnancy, and Breastfeeding

Precautions

It is unknown whether imiquimod can harm a developing fetus, so patients are advised to avoid pregnancy during treatment. Effective contraception should be used before, during, and after treatment. Breastfeeding is also not recommended during imiquimod treatment due to the unknown risk of the drug passing into breast milk[1].

Future Projections and Trends

Growing Demand for Topical Treatments

The increasing prevalence of actinic keratosis and other skin conditions is expected to drive the demand for topical treatments like imiquimod. The global actinic keratosis treatment market is projected to grow from USD 7.14 billion in 2025 to USD 10.25 billion by 2033, at a CAGR of 4.1% during the forecast period[5].

Advancements in Immunomodulation

The immunomodulatory role of imiquimod continues to be a focus of research, with potential applications in treating various cutaneous and possibly other types of cancers. Ongoing and future clinical trials will likely explore its efficacy in new indications and combinations with other treatments[3].

Key Takeaways

• Clinical Trials: Imiquimod is being explored for new applications, including cutaneous breast cancer, with promising results in preclinical and phase II trials.
• Market Dominance: Imiquimod holds a significant market share in the treatment of genital warts and actinic keratosis.
• Side Effects: Common side effects include skin itching and redness, while rare side effects can include mood changes and flu-like symptoms.
• Safety Precautions: Patients should avoid pregnancy and breastfeeding during treatment and report any severe side effects promptly.
• Future Projections: The demand for imiquimod and other topical treatments is expected to grow due to increasing prevalence of skin conditions.

FAQs

Q: What is imiquimod used to treat?

Imiquimod is used to treat basal cell carcinoma, actinic keratosis, genital warts, and other non-cancerous skin conditions.

Q: How does imiquimod work?

Imiquimod works by stimulating the body's immune system to produce natural substances that fight the targeted skin conditions.

Q: What are the common side effects of imiquimod?

Common side effects include skin itching, redness, and rash. Occasional side effects can include small bumps on the skin and swollen lymph nodes.

Q: Can imiquimod be used during pregnancy or breastfeeding?

No, it is advised to avoid pregnancy and breastfeeding during imiquimod treatment due to the unknown risk of the drug passing into breast milk or harming a developing fetus.

Q: What is the market outlook for imiquimod in the coming years?

The market for imiquimod is expected to grow, driven by the increasing prevalence of skin conditions and the demand for topical treatments. The global actinic keratosis treatment market and genital warts treatment market are projected to grow significantly over the next decade.

Sources

1. Cancer Research UK: Imiquimod cream (Aldara) - Cancer Research UK
2. Market.us: Genital Warts Treatment Market Size, Share | CAGR of 4.9%
3. AACR Journals: Breast Cancer Treatment with Imiquimod: Applying an Old Lotion to ...
4. American Academy of Dermatology: Imiquimod: A treatment for some skin cancers, genital warts
5. Straits Research: Global Actinic Keratosis Treatment Market Size ... - Straits Research