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NCT05231044
A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp
Phase 3 trial testing KX01 ointment 1% in Actinic Keratosis in 108 participants. Completed in 20 November 2023.
20 November 2023
Quick facts
| Lead sponsor | PharmaEssentia |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 21 December 2021 |
| Primary completion | 20 November 2023 |
| Estimated completion | 20 November 2023 |
| Sites | 20 locations across Japan |
Drugs / interventions tested
- KX01 ointment 1% — full drug profile →
- Placebo
Conditions studied
- Actinic Keratosis — all drugs for Actinic Keratosis →
Sponsor
PharmaEssentia — full company profile →
Who can join
20 and older, any sex, with Actinic Keratosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05231044
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of KX01 ointment 1%
Trials testing the same drug.
- NCT05245578 — Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects · Phase 1 · completed
Other recruiting trials for Actinic Keratosis
Currently open trials in the same condition.
- NCT06778434 — The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans · Phase 2 · recruiting
- NCT05699603 — Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Prec · Phase 2 · active not recruiting
Other PharmaEssentia trials
Trials by the same sponsor.
- NCT06290765 — Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera · Phase 4 · not yet recruiting
- NCT06468033 — P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk · Phase 3 · recruiting
- NCT07053904 — Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors · Phase 1 · enrolling by invitation
- NCT06698861 — A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers · Phase 1 · completed
- NCT06665776 — HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05231044 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PharmaEssentia
- Last refreshed: 19 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05231044.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing