CLINICAL TRIALS PROFILE FOR VANIQA

All Clinical Trials for VANIQA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03794349 ↗	Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2019-05-28	This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
NCT03794349 ↗	Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma	Active, not recruiting	Children's Oncology Group	Phase 2	2019-05-28	This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
NCT01817894 ↗	Treatment With Topical Eflornithin After Laser Treatment in Women With Facial Hirsutism	Completed	Bispebjerg Hospital	Phase 4	2012-01-01	Split-face investigation of the efficacy of applying Eflornithin cream twice daily for six months after a period with six laser treatments for hair removal.
NCT00601640 ↗	Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin	Completed	National Cancer Institute (NCI)	Phase 2	2007-01-01	RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.
NCT00601640 ↗	Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin	Completed	University of Arizona	Phase 2	2007-01-01	RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.

Clinical Trial Conditions for VANIQA

Condition Name

Condition Name for VANIQA
Intervention	Trials
Ganglioneuroblastoma	1
High Risk Neuroblastoma	1
Hirsutism	1
Non-melanomatous Skin Cancer	1

Condition MeSH

Condition MeSH for VANIQA
Intervention	Trials
Neuroblastoma	1
Ganglioneuroblastoma	1
Hirsutism	1
Skin Neoplasms	1

Clinical Trial Locations for VANIQA

Trials by Country

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Trials by Country for VANIQA
Location	Trials
United States	44
Canada	5
Australia	5
New Zealand	2
Denmark	1

Trials by US State

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−

Trials by US State for VANIQA
Location	Trials
South Dakota	1
California	1
South Carolina	1
Arkansas	1
Rhode Island	1

Clinical Trial Progress for VANIQA

Clinical Trial Phase

Clinical Trial Phase for VANIQA
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for VANIQA
Clinical Trial Phase	Trials
Completed	2
Active, not recruiting	1

Clinical Trial Sponsors for VANIQA

Sponsor Name

Sponsor Name for VANIQA
Sponsor	Trials
National Cancer Institute (NCI)	2
University of Arizona	1
Bispebjerg Hospital	1

Sponsor Type

Sponsor Type for VANIQA
Sponsor	Trials
Other	3
NIH	2

Vaniqa: Clinical Trials, Market Analysis, and Projections

Introduction to Vaniqa

Vaniqa, also known as eflornithine 11.5% cream, is a topical treatment designed to reduce excessive hair growth, particularly on the face and under the chin. It is the first and only FDA-approved topical treatment for this condition.

Clinical Trials Overview

The efficacy and safety of Vaniqa were evaluated in two double-blind, randomized, vehicle-controlled clinical trials involving 596 women with skin types I-VI. Here are the key findings:

Trial Design and Participants

• The trials included 395 women treated with Vaniqa and 201 women treated with a vehicle (placebo) for up to 24 weeks[1][4].

Assessment and Outcomes

• Physicians assessed the change from baseline on a 4-point scale (clear/almost clear, marked improvement, improved, no improvement/worse) 48 hours after shaving the treated areas.
• Significant improvements were observed as early as 8 weeks after initiation of treatment.
• At the end of the 24-week treatment period, the combined results showed:
  • Vaniqa 11.5% cream: 6% clear/almost clear, 29% marked improvement, 35% improved, and 30% no improvement/worse.
  • Vehicle: 0% clear/almost clear, 9% marked improvement, 33% improved, and 58% no improvement/worse[1][4].

Subgroup Analysis

• Subgroup analysis revealed differences in treatment success:
  • Non-white women: 27% showed marked or better improvement.
  • White women: 39% showed marked or better improvement.
  • Obese women (BMI ≥ 30): 29% showed marked or better improvement.
  • Normal weight women (BMI < 30): 43% showed marked or better improvement.
  • Postmenopausal women: Significant improvement (p < 0.001) was seen in this subgroup[1].

Safety Profile

Clinical Safety Data

• Over 2,000 patients have been exposed to topical eflornithine in clinical trials, with no significant adverse effects on fertility, teratogenicity, or carcinogenic potential observed[4].

Non-Clinical Safety Data

• Preclinical studies, including repeat dose toxicity, genotoxicity, and carcinogenic potential, showed no special hazard for humans. Dermal fertility and teratology studies in rats and rabbits also indicated no adverse effects at doses up to 180 and 36 times the human dose, respectively[4].

Market Analysis

Current Market Status

• Vaniqa is a niche product targeting a specific condition, and its market is relatively specialized compared to broader pharmaceutical markets.

Competitive Landscape

• The market for treatments targeting excessive hair growth is limited, with Vaniqa being one of the few FDA-approved options. This gives it a competitive edge, although it faces competition from other hair reduction methods such as laser treatments and depilatory creams.

Market Projections

Demand and Growth

• While specific market size projections for Vaniqa are not readily available, the demand for cosmetic and dermatological treatments is generally increasing. This trend is driven by consumer preferences for aesthetic improvements and the growing awareness of available treatments.

Consumer Preferences

• The broader trend in the healthcare and cosmetics industry towards natural and organic products could indirectly benefit Vaniqa, as consumers become more inclined towards topical treatments over more invasive procedures[2].

Financial and Regulatory Considerations

Pricing and Accessibility

• The pricing of Vaniqa can be a factor in its market penetration. It is generally more expensive than over-the-counter hair removal products, which may limit its accessibility to some consumers.

Regulatory Environment

• Vaniqa has already received FDA approval, which is a significant regulatory milestone. However, ongoing monitoring and potential updates to its labeling or usage guidelines could impact its market position.

Key Takeaways

• Clinical Efficacy: Vaniqa has demonstrated significant efficacy in reducing excessive hair growth in clinical trials, with improvements seen as early as 8 weeks.
• Safety Profile: The drug has a favorable safety profile, with no major adverse effects observed in clinical and preclinical studies.
• Market Position: Vaniqa holds a unique position in the market as an FDA-approved topical treatment for excessive hair growth.
• Market Trends: The demand for cosmetic and dermatological treatments is increasing, which could benefit Vaniqa.

FAQs

What is Vaniqa used for?

Vaniqa is used to reduce excessive hair growth on the face and under the chin.

How effective is Vaniqa in clinical trials?

In clinical trials, Vaniqa showed significant improvements in reducing hair growth, with 6% of patients achieving a clear/almost clear result and 29% showing marked improvement by the end of the 24-week treatment period[1].

Is Vaniqa safe to use?

Vaniqa has a favorable safety profile, with no significant adverse effects observed in clinical and preclinical studies[4].

How does Vaniqa compare to other hair removal methods?

Vaniqa is a topical treatment that offers a less invasive alternative to laser treatments and other hair removal methods, making it a preferred option for some consumers.

What are the potential market projections for Vaniqa?

While specific projections are not available, the growing demand for cosmetic and dermatological treatments suggests a positive outlook for Vaniqa's market position.

Sources

1. Medicines.org.uk: Vaniqa 11.5% cream - Summary of Product Characteristics (SmPC).
2. StraitsResearch: Vanilla Market Size to Surpass US$5253.25 million in 2032.
3. StockTitan: Vivani Medical Provides Update on Clinical Development Plans for ...
4. LancsMMG: New Medicine Assessment - Eflornithine (Vaniqa).
5. PRNewswire: USD 117.3 Billion Growth expected in Vanilla Market by 2025.