A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp
Public ClinicalTrials.gov record NCT03115476. 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
Incidence of Squamous Cell Carcinoma and Other Skin Neoplasia in Subjects With Actinic Keratosis Treated With Ingenol Disoxate Gel 0.018% or 0.037%, or Vehicle Gel
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.
Study identification
- NCT ID
- NCT03115476
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 563 participants
Conditions and interventions
Conditions
Interventions
- ingenol disoxate gel 0.018% Drug
- ingenol disoxate gel 0.037% Drug
- Vehicle gel Other
Drug · Other
Eligibility (public fields only)
- Age range
- Not listed
- 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
- Jun 16, 2017 (Actual)
- Primary completion
- Mar 12, 2018 (Actual)
- Completion
- Mar 12, 2018 (Actual)
- Last update posted
- Mar 11, 2025
2017 – 2018
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | — |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | — |
| Dermatology Specialists, Inc | Murrieta | California | 92562 | — |
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | — |
| Contour Dermatology & Cosmetic Surgery Center | Rancho Mirage | California | 92270 | — |
| Skin Surgery Medical Group, Inc. | San Diego | California | 92117 | — |
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| University Clinical Trials, Inc. | San Diego | California | 92123 | — |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | — |
| Colorado Medical Research Center, Inc. | Denver | Colorado | 80210 | — |
| AboutSkin Dermatology and DermSurgery, PC | Greenwood Village | Colorado | 80111 | — |
| Dermatology and Dermatologic Surgery | Danbury | Connecticut | 06810 | — |
| The GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | — |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | — |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | — |
| Visions Clincal Research | West Palm Beach | Florida | 33406 | — |
| MedaPhase | Newnan | Georgia | 30263 | — |
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | — |
| Laser & Skin Surgery Center of Indiana | Carmel | Indiana | 46032 | — |
| Research Institute of Deaconess Clinic | Evansville | Indiana | 47713 | — |
| DermAssociates, PC | Rockville | Maryland | 20850 | — |
| ActivMed Practices & Research, Inc. | Methuen | Massachusetts | 01844 | — |
| Clarkston Skin Research | Clarkston | Michigan | 48346 | — |
| Clinical Studies Group | Henderson | Nevada | 89074 | — |
| The Dermatology Group, P.C. | Verona | New Jersey | 07044 | — |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | — |
| Center for Clinical Studies | Houston | Texas | 77065 | — |
| Suzanne Bruce and Associates, P.A., The Center for Skin Research | Katy | Texas | 77494 | — |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | — |
| Premier Clinical Research | Spokane | Washington | 99202 | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03115476, 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 11, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03115476 live on ClinicalTrials.gov.