Numerous clinical trials spanning Phase 1 through Phase 4 and post-marketing surveillance have evaluated retapamulin for dermatological and infectious conditions, primarily targeting impetigo, folliculitis, bacterial skin infections, and methicillin-resistant Staphylococcus aureus (MRSA) colonization. Sponsored by pharmaceutical entities such as GlaxoSmithKline and Stiefel alongside academic centers like NYU Langone Health and the University of California, Irvine, these studies examined topical decolonization efficacy and skin concentration kinetics. While multiple late-phase trials successfully reached completion, select early-phase and perioperative MRSA protocols were withdrawn prior to execution.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03304873 | COMPLETED | MRSA |
NYU Langone Health |
2017-12-01 | PHASE3 |
| NCT01461668 | COMPLETED | Methicillin-Resistant Staphylococcus Aureus |
University of California, Irvine |
2012-07 | PHASE4 |
| NCT03304873 | Completed | MRSA |
NYU Langone Health |
2017-12-01 | Phase 3 |
| NCT01812382 | COMPLETED | Skin Infections, Bacterial |
GlaxoSmithKline |
2014-04-02 | PHASE1 |
| NCT01812382 | Completed | Skin Infections Bacterial |
GlaxoSmithKline |
2014-04-02 | Phase 1 |
| NCT01397461 | COMPLETED | Impetigo |
Ferrer Internacional S.A. |
2012-03 | PHASE3 |
| NCT01126268 | COMPLETED | Impetigo; Folliculitis; Secondarily Infected Eczema; Minor Soft Tissue Infections |
The University of Texas Health Science Center, Houston |
2010-04 | PHASE4 |
| NCT01445600 | Completed | Skin Infections Bacterial |
GlaxoSmithKline |
2012-11 | -- |
| NCT01591785 | COMPLETED | Hand Eczema; Foot Eczema |
Gary Goldenberg |
2012-01 | |
| NCT01064947 | COMPLETED | Atopic Dermatitis; Secondary Infection |
Derm Research, PLLC |
2010-02 | PHASE4 |
| NCT00852540 | COMPLETED | Skin Infections, Bacterial |
Stiefel, a GSK Company |
2009-04 | PHASE3 |
| NCT00856089 | WITHDRAWN | Methicillin-resistant Staphylococcus Aureus |
Ochsner Health System |
2009-05 | PHASE4 |
| NCT00684177 | COMPLETED | Skin Infections, Bacterial |
GlaxoSmithKline |
2008-05 | PHASE3 |
| NCT00903279 | Withdrawn | Orthopedic Procedures|Methicillin-resistant Staphylococcus Aureus |
Bay Pines VA Healthcare System |
2009-08 | Phase 2 |
| NCT00555061 | COMPLETED | Skin Infections, Bacterial |
GlaxoSmithKline |
2007-09 | PHASE4 |
| NCT00539994 | COMPLETED | Infections, Bacterial |
GlaxoSmithKline |
2007-09 | PHASE2 |
| NCT00903279 | WITHDRAWN | Orthopedic Procedures; Methicillin-resistant Staphylococcus Aureus |
Bay Pines VA Healthcare System |
2009-08 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2020-03-19)
Mechanism and Biochemical Profile
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>).