Drugs / Hydrocortisone Butyrate
Hydrocortisone Butyrate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOCOID LIPOCREAM | — | 2009-10-19 | fda.gov ↗ |
| Approved | US (FDA) | LOCOID | — | 1982-03-31 | fda.gov ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02973776 | Dec 2016 → Feb 2017 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00640614 | Apr 2008 → Aug 2009 | contact dermatitis | Allerderm | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02959580 | Jan 2017 → Sep 2020 | granulomatous mastitis | Peking Union Medical College Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03758365 Comparator | Nov 2018 | vascular disorder | MC2 Therapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03676933 Background | Oct 2015 → Apr 2016 | atopic eczema | DS Biopharma | Completed | No outcome recorded |
| Phase 2 | NCT00801957 Comparator | Mar 2003 → Nov 2004 | atopic eczema | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03766997 Background | Feb 2019 → Jan 2021 | granulomatous mastitis | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03539601 Comparator | Apr 2018 → Dec 2020 | atopic eczema | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT02116608 Comparator | Sep 2014 → Sep 2019 | tracheal disorder | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 4 | NCT00693693 Comparator | Nov 2006 → Sep 2008 | atopic eczema | Wake Forest University | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hydrocortisone Butyrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03758365 ↗ |
| Known as | hydrocortisone 17-butyrate | “Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse...” NCT00640614 ↗ |
| Known as | Locoid | “Locoid® hydrocortisone-17-butyrate 0.1% ointment” NCT02973776 ↗ |
| Route | Topical | “topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis” NCT00693693 ↗ |