CLINICAL TRIALS PROFILE FOR ACETIC ACID 0.25% IN PLASTIC CONTAINER

« Back to Dashboard

All Clinical Trials for ACETIC ACID 0.25% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003697 ↗	Dimethylxanthenone Acetic Acid in Treating Patients With Solid Tumors	Completed	University of Glasgow	Phase 1	1995-10-01	RATIONALE: Dimethylxanthenone acetic acid may stop the growth of cancer cells by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of dimethylxanthenone acetic acid in treating patients with solid tumors that have not responded to previous therapy.
NCT00044213 ↗	Trial to Assess Chelation Therapy (TACT)	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 3	2003-09-01	The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
NCT00044213 ↗	Trial to Assess Chelation Therapy (TACT)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	2003-09-01	The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
NCT00044213 ↗	Trial to Assess Chelation Therapy (TACT)	Completed	Mt. Sinai Medical Center, Miami	Phase 3	2003-09-01	The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
NCT00051545 ↗	Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma	Terminated	LEO Pharma	Phase 3	1999-11-01	To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).
NCT00116454 ↗	Trial for Hepatocellular Carcinoma Adjuvant Treatment by Lipiocis	Completed	ANRS, Emerging Infectious Diseases	Phase 3	2005-07-01	The recurrence of hepatocellular carcinoma (HCC), two years after curative treatment is high, about 40% - 50%. Recently, it has been shown that intra-arterial radioactive lipiodol (Lipiocis®) could reduce the recurrence of cancer and increase the survival after resection of HCC developed on cirrhosis B. The aim of the present trial is to investigate the effect of Lipiocis® in preventing recurrence after curative treatment of HCC in patients with viral or alcoholic hepatitis related cirrhosis by surgical or percutaneous ablation.

Clinical Trial Conditions for ACETIC ACID 0.25% IN PLASTIC CONTAINER

Condition Name

Condition Name for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Intervention	Trials
Cervical Cancer	3
Unspecified Adult Solid Tumor, Protocol Specific	3
Cervical Cancers	2
Apical Periodontitis	2

Condition MeSH

Condition MeSH for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Intervention	Trials
Uterine Cervical Neoplasms	6
Neoplasms	5
Carcinoma	4
Uterine Cervical Dysplasia	4

Clinical Trial Locations for ACETIC ACID 0.25% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Location	Trials
United States	52
Egypt	10
Canada	8
Italy	7
Spain	5

Trials by US State

Trials by US State for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Location	Trials
California	6
Texas	5
New York	4
North Carolina	3
New Jersey	3

Clinical Trial Progress for ACETIC ACID 0.25% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	4

Clinical Trial Status

Clinical Trial Status for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	40
Unknown status	11
Recruiting	10

Clinical Trial Sponsors for ACETIC ACID 0.25% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Sponsor	Trials
National Cancer Institute (NCI)	7
M.D. Anderson Cancer Center	4
Tanta University	3

Sponsor Type

Sponsor Type for ACETIC ACID 0.25% IN PLASTIC CONTAINER
Sponsor	Trials
Other	104
Industry	17
NIH	10

Last updated: July 28, 2026

Acetic Acid 0.25% in Plastic Container: Clinical Trials Update, Market Analysis, and Projections

Acetic acid 0.25% in a plastic container is an over-the-counter (OTC) or low-prescription segment liquid product positioned for local use. A “clinical trials update” and “market projection” require a specific FDA-approved drug product record (NDC) and an evidentiary trail in registries (e.g., ClinicalTrials.gov) or label/IP documents that tie to that exact dosage strength and presentation. No such product-level identifiers, trial entries, or Orange Book/NDC-linked data are provided here, so a complete and accurate clinical and commercial assessment cannot be produced.

What is acetic acid 0.25% in plastic container and what is it used for?

No product-specific facts provided. “Acetic acid 0.25% in plastic container” could describe multiple marketed products that vary by indication, labeling (OTC vs prescription), packaging, and regulatory classification.

Is acetic acid 0.25% for otitis externa, ear irrigation, or another indication?

No indication mapping can be determined from the input alone.

Is the product OTC or prescription and what is the FDA regulatory status?

No NDC, dosage form code, or FDA listing details are provided.

---

What clinical trials have been completed or are ongoing for acetic acid 0.25% in this formulation?

No registry-linked trial data is provided. A “clinical trials update” requires at least one of the following: trial registry URLs/IDs, sponsor names, protocol titles, or an FDA label/NDC link that anchors the exact product to a trial program.

Are there Phase 1, Phase 2, or Phase 3 trials?

No trial phases can be stated without trial identifiers.

Do trials address formulation or packaging (plastic container) specifically?

No formulation-specific endpoints can be asserted without sourcing.

What endpoints and comparators are used (efficacy, safety, microbiology)?

No endpoint detail is available from the input.

---

What is the market size and growth outlook for acetic acid 0.25% solutions?

No market data is provided. Market sizing and growth projection depend on anchoring to:

• the correct product (strength + container + labeling),
• country scope,
• channel (retail OTC vs institutional),
• and consistent product definition across data providers.

Which geographies drive demand (US, EU5, UK, Canada, LATAM)?

No geographic scope is provided.

How does pricing vary by container type and distributor?

No pricing, reimbursement, or channel data is provided.

---

How do you forecast revenue and unit demand for acetic acid 0.25% in plastic containers?

A revenue or unit projection needs a baseline and drivers:

• current sales or unit volumes,
• uptake or displacement rates,
• competition intensity,
• regulatory or supply constraints,
• and shelf-life/storage implications by container.

None of these inputs are provided.

What adoption drivers apply (guideline use, hospital formularies, OTC switching)?

No commercial adoption factors are provided.

What supply and manufacturing risks exist for this category?

No supplier or manufacturing site data is provided.

---

What competitive landscape risks exist for acetic acid 0.25% products?

A credible competitive analysis depends on identifying labeled competitors and package-level differences (container, preservative, concentration, indication).

Which companies manufacture equivalent acetic acid solutions at 0.25%?

No manufacturer list can be produced from the input.

Is there substitution by other strengths or alternative agents (e.g., boric acid, antibiotic/antiseptic drops)?

No competitive substitutes can be enumerated without market/label confirmation.

---

What exclusivity or IP barriers affect generic or re-packaged entry?

This requires Orange Book patent listings, exclusivity determinations, or litigation/settlement records tied to the exact FDA product.

Are there listed patents for use, formulation, or manufacturing?

No patent dataset is provided.

Does any Paragraph IV certification or settlement exist?

No litigation data is provided.

---

What is the Orange Book status of acetic acid 0.25% in plastic container?

No FDA references, NDC, or Orange Book entries are supplied. A product-level Orange Book status cannot be stated.

---

What generic entry risks exist for acetic acid 0.25% solutions?

Generic risk is driven by regulatory classification and product-specific barriers. Without NDC/label records or patents, no risk level can be quantified.

---

How does acetic acid 0.25% in plastic containers compare with other acetic acid strengths or packaging?

No comparative label or stability evidence is provided.

Are higher or lower concentrations clinically interchangeable?

No clinical equivalence data is provided.

---

Key Takeaways

• A clinical trials update and market projection for “acetic acid 0.25% in plastic container” cannot be produced without product-level regulatory identifiers and trial/registry anchoring data.
• No FDA status, patent estate, competitive roster, or quantified forecast assumptions are provided in the input.

FAQs

1. How can I identify the correct FDA product entry for acetic acid 0.25% solutions by NDC?
2. What ClinicalTrials.gov search terms capture trials for acetic acid 0.25% ear preparations or antiseptic ear drops?
3. What are the most common regulatory pathways for locally acting OTC solutions and how do they affect market entry timing?
4. How do container type and preservation systems (if any) change stability and labeling requirements for topical solutions?
5. What data sources best support market sizing for OTC/local antiseptic solution categories in the US and EU?

References

1. ClinicalTrials.gov. (n.d.). Database. https://clinicaltrials.gov/
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/