Clinical Trials

Several completed clinical trials, encompassing Phase 4 designs and unclassified protocols, have evaluated allantoin across dermatological, metabolic, and physiological indications. Sponsored by academic institutions, healthcare organizations, and industry partners, these studies investigated applications including intertrigo, post-cesarean scar dehiscence and wound healing, neonatal oxidative stress, dietary uric acid metabolism, and exercise performance. Ultimately, these investigations assess allantoin's topical utility for cutaneous repair alongside its systemic involvement in metabolic and oxidative pathways.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06338410 Completed
Kangaroo Mother Care|Oxidative Stress
University of Health Sciences Lahore|Services Hospital Lahore
 2023-08-01 Not Applicable
NCT04325490 Completed
Intertrigo
Mahidol University|HOE pharmaceuticals Sdn. Bhd.
 2019-10-01 Phase 4
NCT04046783 Completed
Cesarean Section; Dehiscence|Scar Keloid|Wound Heal
University of Salerno
 2019-03-02 --
NCT03849677 Completed
Healthy|Diet Modification
Erasme University Hospital|Fonds National de la Recherche Scientifique|Fonds Erasme|Fonds pour la chirurgie cardiaque
 2019-03-10 --
NCT03631394 Completed
Exercise
Loma Linda University
 2018-09-01 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Allantoin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a purine catabolite derived from uric acid, allantoin stimulates extracellular matrix synthesis, enhances epithelial cell proliferation, and promotes the hydrated desquamation of cornified tissue. This cell-renewing and barrier-soothing mechanism provides the biological basis for its clinical investigation in accelerating skin wound healing, mitigating keloid scar formation after cesarean section, and alleviating inflammatory dermatoses such as intertrigo.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.