CLINICAL TRIALS PROFILE FOR PICATO

All Clinical Trials for Picato

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01541553 ↗	A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp	Completed	LEO Pharma	Phase 3	2012-03-01	The purpose of this trial is to compare the rate of complete clearance of actinic keratosis (AK) using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.
NCT01803477 ↗	Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm	Completed	LEO Pharma	Phase 1/Phase 2	2013-02-01	The purpose of this study is to determine if the new vehicle formulations containing ingenol mebutate are as safe and effective as Picato® gel 0.05% (it's current vehicle formulation) when applied to AK lesions on the forearm for two consecutive days.
NCT02090465 ↗	Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks	Completed	LEO Pharma		2013-07-01	Assessment of treatment success and quality of life in patients with actinic keratoses under therapy with Ingenol Mebutate (Picato) in a period of 8 weeks.
NCT02242747 ↗	Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis	Completed	LEO Pharma	N/A	2014-05-01	Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy. Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial AKs. Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.
NCT02242747 ↗	Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis	Completed	University of Sao Paulo	N/A	2014-05-01	Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy. Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial AKs. Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.
NCT02281682 ↗	IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis	Unknown status	Maastricht University Medical Center	Phase 4	2014-11-01	A multi-centre randomised controled single blind clinical phase IV trial with the aim to determine the most effective treatment in terms of lesion reduction, costs and patient satisfaction in treatment of actinic keratosis (AK), when comparing topical treatment with photodynamic therapy (PDT), 5% 5-fluorouracil (5-FU) cream, 5% Imiquimod (IMI) cream and ingenol mebutate (IM) gel.

Clinical Trial Conditions for Picato

Condition Name

Condition Name for Picato
Intervention	Trials
Actinic Keratosis	13
Anogenital Warts	1
Carcinoma	1
Keratosis, Actinic	1

Condition MeSH

Condition MeSH for Picato
Intervention	Trials
Keratosis, Actinic	14
Keratosis	14
Lentigo	1
Hutchinson's Melanotic Freckle	1

Clinical Trial Locations for Picato

Trials by Country

Trials by Country for Picato
Location	Trials
United States	47
Netherlands	2
Korea, Republic of	1
Italy	1
Germany	1

Trials by US State

Trials by US State for Picato
Location	Trials
Texas	4
California	4
Tennessee	3
Indiana	3
Illinois	3

Clinical Trial Progress for Picato

Clinical Trial Phase

Clinical Trial Phase for Picato
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Picato
Clinical Trial Phase	Trials
Completed	13
Unknown status	5
Withdrawn	1

Clinical Trial Sponsors for Picato

Sponsor Name

Sponsor Name for Picato
Sponsor	Trials
LEO Pharma	11
Actavis Inc.	2
Centre Hospitalier Universitaire de Nice	2

Sponsor Type

Sponsor Type for Picato
Sponsor	Trials
Industry	13
Other	11

Picato: Clinical Trials, Market Analysis, and Projections

Introduction to Picato

Picato, also known as ingenol mebutate, is a topical prescription drug used to treat actinic keratosis (AK), a condition characterized by thick, hard, and scaly patches on the skin due to excessive sun exposure. It is available in two strengths: 0.015% and 0.05% gel formulations.

Clinical Trials and Safety Concerns

Efficacy in Clinical Trials

Clinical trials have shown that Picato is effective in treating actinic keratosis. In two double-blind, vehicle-controlled clinical trials, subjects with AK on the trunk, extremities, face, or scalp were treated with Picato gel. The trials demonstrated significant complete and partial clearance rates of AK lesions. For example, in trials using the 0.015% gel, complete clearance rates ranged from 37% to 47%, and partial clearance rates (≥ 75% reduction) ranged from 60% to 68%[4].

Safety Concerns and Risk of Skin Cancer

However, recent safety reviews have raised concerns about the potential link between Picato and an increased risk of skin cancer. Health Canada conducted a safety review and found that there may be a link between Picato and an increased risk of skin cancer, including squamous cell carcinoma. This review included data from clinical trials, case reports, and scientific literature[1].

In the European Union, the European Medicines Agency (EMA) also conducted a safety review after observing a higher number of skin cancer cases in patients using Picato. The review concluded that there was a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas treated with Picato compared to imiquimod. As a result, the marketing authorization for Picato was withdrawn in the EU[3].

Market Analysis

Global Market Overview

The global Picato gel market has been impacted significantly by the safety concerns and regulatory actions. Despite its initial approval and market presence, the drug's future in many regions is uncertain.

Market Size and Growth

The global market for actinic keratosis treatments, which includes Picato, is expected to see moderate growth. However, the specific market share of Picato is likely to decline due to the safety concerns. The U.S. actinic keratosis treatment market, for example, is projected to grow at a compound annual growth rate (CAGR) of 3.03% from 2023 to 2030, but this growth is largely driven by other topical treatments like nucleoside metabolic inhibitors (e.g., Fluroplex, Carac, and Efudex)[5].

Regional Analysis

The market for Picato has been most significantly affected in the European Union, where the drug has been withdrawn from the market. In contrast, Picato remains available in the United States, although the FDA is also reviewing its safety and risks[3].

Competitive Landscape

The competitive landscape for actinic keratosis treatments is diverse, with several other topical and systemic treatments available. The withdrawal of Picato from certain markets has created opportunities for other treatments to gain market share. For instance, imiquimod, which was compared to Picato in safety reviews, is likely to see increased usage as a safer alternative[3].

Market Projections

Future Outlook

Given the safety concerns and regulatory actions, the future market prospects for Picato are challenging. The drug's continued availability in the U.S. market is contingent on the outcome of the FDA's safety review. If the FDA decides to withdraw or restrict the use of Picato, it would significantly impact the drug's global market presence.

Impact on Actinic Keratosis Treatment Market

The actinic keratosis treatment market will likely see a shift towards other topical treatments that have a safer profile. The growth of the market will be driven by increased awareness and diagnosis of actinic keratosis, as well as the strong commercial performance of alternative treatments[5].

Recommendations for Patients and Healthcare Providers

Patients who have used Picato are advised to watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur. Healthcare providers should consider alternative treatment options for actinic keratosis, given the potential risks associated with Picato[3].

Key Takeaways

• Efficacy: Picato has shown significant efficacy in treating actinic keratosis in clinical trials.
• Safety Concerns: There is a potential link between Picato and an increased risk of skin cancer, leading to regulatory actions in several regions.
• Market Impact: The global market for Picato has been negatively impacted by safety concerns and regulatory withdrawals.
• Future Outlook: The drug's future is uncertain, with its continued availability dependent on ongoing safety reviews.
• Alternative Treatments: Other topical treatments are gaining market share due to their safer profiles.

FAQs

What is Picato used for?

Picato is used to treat actinic keratosis, a condition characterized by thick, hard, and scaly patches on the skin due to excessive sun exposure.

What are the safety concerns associated with Picato?

There is a potential link between Picato and an increased risk of skin cancer, including squamous cell carcinoma.

Why was Picato withdrawn from the European market?

Picato was withdrawn from the European market due to a higher occurrence of skin cancers in areas treated with the drug compared to other treatments like imiquimod.

Is Picato still available in the United States?

Yes, Picato is still available in the United States, but the FDA is reviewing its safety and risks.

What are the alternative treatments for actinic keratosis?

Alternative treatments include other topical formulations like imiquimod, Fluroplex, Carac, and Efudex, which have a safer profile compared to Picato.

Sources

1. Health Canada: Information Update - Use of the drug Picato may increase the risk of skin cancer.
2. Cognitivemarketresearch.com: Global Picato Gel Market Report 2024 Edition.
3. The Hospitalist: EU panel review supports decision to pull Picato from market.
4. FDA: PICATO® (ingenol mebutate) gel, for topical use.
5. Grandviewresearch.com: U.S. Actinic Keratosis Treatment Market Size Report, 2030.