CLINICAL TRIALS PROFILE FOR TERRA-CORTRIL

All Clinical Trials for TERRA-CORTRIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT00557193 ↗	Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	Children's Oncology Group	Phase 3	2008-01-14	This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	National Cancer Institute (NCI)	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.
NCT00536991 ↗	Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer	Terminated	Roswell Park Cancer Institute	Phase 1/Phase 2	2006-10-01	This phase I/II trial studies the side effects and best dose of calcitriol when given in combination with ketoconazole and therapeutic hydrocortisone and to see how well it works in treating patients with prostate cancer. Calcitriol may help prostate cancer cells become more like normal cells and grow and spread more slowly. Ketoconazole and therapeutic hydrocortisone may help calcitriol work better by making tumor cells more sensitive to the drug. Giving calcitriol together with ketoconazole and therapeutic hydrocortisone may be a better treatment for prostate cancer.

Clinical Trial Conditions for TERRA-CORTRIL

Condition Name

Condition Name for TERRA-CORTRIL
Intervention	Trials
B Acute Lymphoblastic Leukemia	2
Acute Lymphoblastic Leukemia	2
Untreated Childhood Acute Lymphoblastic Leukemia	2
Diffuse Large B-Cell Lymphoma	1

Condition MeSH

Condition MeSH for TERRA-CORTRIL
Intervention	Trials
Leukemia	4
Precursor Cell Lymphoblastic Leukemia-Lymphoma	3
Leukemia, Lymphoid	3
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma	2

Clinical Trial Locations for TERRA-CORTRIL

Trials by Country

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Trials by Country for TERRA-CORTRIL
Location	Trials
United States	213
Canada	30
Australia	5
New Zealand	5
Puerto Rico	3

Trials by US State

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−

Trials by US State for TERRA-CORTRIL
Location	Trials
Illinois	7
New York	6
Ohio	6
Minnesota	6
Massachusetts	6

Clinical Trial Progress for TERRA-CORTRIL

Clinical Trial Phase

Clinical Trial Phase for TERRA-CORTRIL
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	1
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for TERRA-CORTRIL
Clinical Trial Phase	Trials
Active, not recruiting	4
Recruiting	2
Terminated	1

Clinical Trial Sponsors for TERRA-CORTRIL

Sponsor Name

Sponsor Name for TERRA-CORTRIL
Sponsor	Trials
National Cancer Institute (NCI)	8
Children's Oncology Group	4
Roswell Park Cancer Institute	1

Sponsor Type

Sponsor Type for TERRA-CORTRIL
Sponsor	Trials
NIH	8
Other	8
Industry	1

Terra-Cortril: Clinical Trials, Market Analysis, and Projections

Introduction

Terra-Cortril is a topical ointment or suspension that combines the antibiotic oxytetracycline and the corticosteroid hydrocortisone. It is widely used for treating various skin and eye conditions, including eczema, dermatitis, and secondarily infected lesions. Here, we will delve into the clinical trials, market analysis, and future projections for Terra-Cortril.

Clinical Trials Overview

Completed Trials

One notable clinical trial involving Terra-Cortril was registered in the EU Clinical Trials Register. This trial, with the EudraCT number 2011-001407-13, was a Phase II study aimed at evaluating the efficacy and safety of Terra-Cortril in treating various dermatological conditions. The trial was completed and involved 100 adult participants, with the primary objectives focusing on the prophylaxis, therapy, safety, and efficacy of the treatment[1].

Recent Findings

Recent studies have raised some concerns about the use of Terra-Cortril in dental procedures. A retrospective cohort study published in 2021 found that the use of Terra-Cortril in extraction sockets increased the likelihood of unsuccessful healing and greater bone defects, which could complicate subsequent implant placement. This study highlighted significant surgical consequences associated with Terra-Cortril use, such as a higher odds ratio for unsuccessful healing[3].

Pain and Discomfort Reduction

On the other hand, a study published in PLOS ONE in 2021 showed that using oxytetracycline-hydrocortisone ointment in extraction sockets after third molar extraction reduced the occurrence of dry socket and spontaneous pain. This study indicated a positive outcome in terms of pain management and reducing the incidence of dry socket[4].

Market Analysis

Indications and Usage

Terra-Cortril is indicated for various dermatological conditions, including exudative and secondarily infected eczema, primary irritant dermatitis, allergic and seborrhoeic dermatitis, and secondarily infected insect bite reactions. It is also used in ophthalmic and dental applications, although the latter has shown mixed results[2][5].

Market Demand

The demand for Terra-Cortril is driven by its broad-spectrum antibacterial and anti-inflammatory properties, making it a versatile treatment option for several common skin and eye conditions. The market for topical antibiotics and corticosteroids is substantial, particularly in regions with high prevalence rates of skin infections and inflammatory diseases.

Competitive Landscape

The market for topical antibiotics and corticosteroids is competitive, with several other products available that combine similar active ingredients. However, Terra-Cortril's specific formulation and established brand presence give it a significant market share. The competition is further intensified by generic versions of similar products, which can affect the pricing and market share of Terra-Cortril.

Market Projections

Growth Potential

Despite the mixed results from recent clinical trials, Terra-Cortril is expected to maintain its market presence due to its established use and efficacy in treating various dermatological conditions. The global market for topical antibiotics and corticosteroids is projected to grow, driven by increasing awareness of skin health and the rising incidence of skin infections.

Challenges and Opportunities

The challenges for Terra-Cortril include the potential for adverse effects, particularly when used in dental procedures, and the competition from other topical treatments. However, opportunities exist in expanding its use in new therapeutic areas and improving its formulation to address the concerns raised by recent studies.

Side Effects and Safety Considerations

Local Side Effects

Terra-Cortril can cause local side effects such as burning, itching, irritation, dryness, and allergic contact dermatitis. These effects are more common when used under occlusive dressings or for prolonged periods[2].

Systemic Absorption

There is limited information on the systemic absorption of oxytetracycline following dermal application, but variable absorption of hydrocortisone has been reported, especially when applied to large surfaces or under occlusive dressings[2].

Regulatory Status

Approvals and Compliance

Terra-Cortril has been approved for use in various countries and complies with regulatory standards for topical antibiotics and corticosteroids. It is classified under the pharmacotherapeutic group of weak corticosteroids combined with antibiotics, with the ATC code D07CA01[2].

Key Takeaways

• Clinical Trials: Recent studies have shown mixed results, with positive outcomes in reducing pain and dry socket but negative outcomes in terms of healing and bone defects in dental procedures.
• Market Analysis: Terra-Cortril has a significant market presence due to its broad-spectrum antibacterial and anti-inflammatory properties, but faces competition from other topical treatments.
• Market Projections: The market for Terra-Cortril is expected to grow, driven by increasing demand for topical antibiotics and corticosteroids, despite challenges and opportunities.
• Side Effects and Safety: Local side effects and variable systemic absorption are important safety considerations.
• Regulatory Status: Terra-Cortril is approved and compliant with regulatory standards.

FAQs

What are the primary indications for Terra-Cortril?

Terra-Cortril is indicated for exudative and secondarily infected eczema, primary irritant dermatitis, allergic and seborrhoeic dermatitis, and secondarily infected insect bite reactions.

What are the active ingredients in Terra-Cortril?

The active ingredients are oxytetracycline and hydrocortisone.

What are the potential side effects of Terra-Cortril?

Potential side effects include burning, itching, irritation, dryness, and allergic contact dermatitis.

Has Terra-Cortril been used in dental procedures?

Yes, but recent studies have raised concerns about its use in dental procedures due to increased risk of unsuccessful healing and greater bone defects.

What is the regulatory status of Terra-Cortril?

Terra-Cortril is approved and classified under the pharmacotherapeutic group of weak corticosteroids combined with antibiotics, with the ATC code D07CA01.

Sources

1. EU Clinical Trials Register: Terra-Cortril + Polymyxine B (oxytetracycline/ hydrocortisone /polymyxin B)[1].
2. Medicines.org.uk: Terra-Cortril ointment - Summary of Product Characteristics (SmPC)[2].
3. Synapse.patsnap.com: Hydrocortisone Acetate/Oxytetracycline Hydrochloride - Drug Overview[3].
4. PLOS ONE: Oxytetracycline-hydrocortisone ointment reduces the occurrence of dry socket after third molar extraction[4].
5. Dailymed.nlm.nih.gov: Label: terra-cortril- oxytetracycline hydrochloride and hydrocortisone acetate suspension[5].