A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis
Public ClinicalTrials.gov record NCT01922050. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations
Study identification
- NCT ID
- NCT01922050
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 320 participants
Conditions and interventions
Conditions
Interventions
- LEO 43204 Formulation 1 Drug
- LEO 43204 Formulation 2 Drug
- LEO 43204 Formulation 1 Dose X Drug
- LEO 43204 Formulation 1 Dose Y Drug
- LEO 43204 Formulation 2 Dose XX Drug
- LEO 43204 Formulation 2 Dose YY Drug
- Placebo Formulation 1 Drug
- Placebo Formulation 2 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2013 (Type not available)
- Primary completion
- Nov 2014 (Actual)
- Completion
- Nov 2014 (Actual)
- Last update posted
- Mar 6, 2025
2013 – 2014
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Omni Dermatology | Phoenix | Arizona | 85018 | — |
| Torrance Clinical Research Institute Inc. | Lomita | California | 90717 | — |
| Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc. | San Diego | California | 92121 | — |
| Leavitt Medical Associates of Florida | Ormond Beach | Florida | 32174 | — |
| Clinical Research Center, Morsani Center for Advanced Healthcare | Tampa | Florida | 33612 | — |
| Research Institute of Deaconess Clinic | Evansville | Indiana | 47713 | — |
| Hudson Dermatology, LLC | Evansville | Indiana | 47714 | — |
| DermAssociates, PC | Rockville | Maryland | 20850 | — |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | — |
| Henry Ford Medical Center, Dept. of Dermatology | West Bloomfield | Michigan | 48322 | — |
| The Dermatology Group, P.C. | Verona | New Jersey | 07044 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01922050, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 6, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01922050 live on ClinicalTrials.gov.