RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
Public ClinicalTrials.gov record NCT02142959. 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
A Randomized, Double-blind, Vehicle-controlled, Parallel-group Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of RTA 408 Lotion in the Treatment of Patients at Risk for Radiation Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation therapy. The most common strategy employed in an attempt to prevent or minimize radiation dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants, such as scratching and rough clothing. However, this strategy has been shown to lack clinically significant efficacy. Consequently, there is a clinical need for new treatments that are effective in protecting against radiotherapy-induced oxidative stress and the subsequent development of radiation dermatitis. Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology patients undergoing radiation therapy. This randomized, double-blind, vehicle-controlled, parallel-group trial will study the efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.
Study identification
- NCT ID
- NCT02142959
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 187 participants
Conditions and interventions
Conditions
Interventions
- Omaveloxolone Lotion 0.5% Drug
- Omaveloxolone Lotion 3% Drug
- Vehicle Lotion Drug
- 3D conformal radiation therapy Radiation
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- Female
- 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 30, 2014 (Actual)
- Primary completion
- Apr 30, 2015 (Actual)
- Completion
- Apr 30, 2015 (Actual)
- Last update posted
- Jun 3, 2025
2014 – 2015
United States locations
- U.S. sites
- 27
- U.S. states
- 17
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers | Mesa | Arizona | 85206 | — |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Arizona Cancer Center | Scottsdale | Arizona | 85258 | — |
| University of Colorado Hospital, Dept. of Radiation Oncology | Aurora | Colorado | 80045 | — |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | — |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | — |
| John B. Amos Cancer Center | Columbus | Georgia | 31904 | — |
| St. Vincent Anderson Regional Hospital Cancer Center | Anderson | Indiana | 46016 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Radiation Oncology Associates - Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46628 | — |
| Willis-Knighton Cancer Center | Shreveport | Louisiana | 71103 | — |
| University of Nebraska Medical Center - Eppley Cancer Center | Omaha | Nebraska | 68198 | — |
| CaroMont Health Comprehensive Cancer Center | Gastonia | North Carolina | 28054 | — |
| Sanford Health | Bismarck | North Dakota | 58501 | — |
| St. John Health System | Tulsa | Oklahoma | 74104 | — |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | — |
| Hughes Cancer Center | East Stroudsburg | Pennsylvania | 18301 | — |
| Mount Nittany Medical Center | State College | Pennsylvania | 16803 | — |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | — |
| 21st Century Oncology - Carolina Regional Cancer Center | Myrtle Beach | South Carolina | 29577 | — |
| Spartanburg Regional Medical Center - Gibbs Cancer Center | Spartanburg | South Carolina | 29303 | — |
| Sanford Research/USD | Sioux Falls | South Dakota | 57104 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Cancer Care Northwest | Spokane | Washington | 99202 | — |
| Mayo Clinic - LaCrosse | La Crosse | Wisconsin | 54601 | — |
| Columbia St. Mary's | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02142959, 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 Jun 3, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02142959 live on ClinicalTrials.gov.