Glycolic acid Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several completed clinical trials have evaluated glycolic acid across diverse applications, including melasma, pharmacokinetic parameters, and flat warts in HIV-infected pediatric patients. Encompassing Phase 1 designs and studies with non-applicable phase designations, these trials were supported by various academic, institutional, and industry sponsors. Key research evaluated chemical peeling for melasma as well as topical treatments for cutaneous viral lesions in pediatric patients.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05362500	Completed	Melasma	Combined Military Hospital Abbottabad	2021-06-01	Phase 1
NCT03437265	Completed	Pharmacokinetic	Norgine\|Quotient Sciences	2020-09-03	Phase 1
NCT01289171	Completed	Flat Warts\|HIV	University of Pennsylvania\|NeoStrata Company Inc.\|Penn Center for AIDS Research (CFAR)	2009-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glycolic acid functions as a tyrosinase inhibitor, blocking enzymatic melanin synthesis within melanocytes to decrease cutaneous pigment accumulation. This suppression of melanin formation directly underlies its clinical utility in lightening skin coloration and managing hyperpigmentation conditions such as melasma.

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>).