RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
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
1 other identifier
interventional
187
1 country
27
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jun 2014
Shorter than P25 for phase_2 breast-cancer
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 20, 2014
CompletedStudy Start
First participant enrolled
June 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2015
CompletedResults Posted
Study results publicly available
May 6, 2023
CompletedJune 3, 2025
May 1, 2025
10 months
May 16, 2014
March 28, 2023
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy to the Breast Following Topical Application of Omaveloxolone Lotion or Lotion Vehicle
CTCAE Radiation dermatitis scoring: Grade 0 = No radiation dermatitis; Grade 1 = Faint erythema or dry desquamation; Grade 2 = Moderate to brisk erythema, patchy moist desquamation, mostly confined to skin folds and creases, moderate edema; Grade 3 = Moist desquamation in areas other than skin folds and creases, bleeding induced by minor trauma or abrasion; Grade 4 = Life-threatening consequences, skin necrosis or ulceration of full thickness dermis, spontaneous bleeding from involved site, skin graft indicated; Grade 5 = Death
Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported
Study Arms (3)
omaveloxolone (RTA 408) Lotion 0.5%
EXPERIMENTALOmaveloxolone Lotion at a fixed dose of 0.5% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
omaveloxolone (RTA 408) Lotion 3%
EXPERIMENTALOmaveloxolone Lotion at a fixed dose of 3% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 19 weeks)
Vehicle Lotion
PLACEBO COMPARATORVehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
Interventions
Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
Omaveloxolone lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
Lotion vehicle manufactured to mimic RTA 408 lotion will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
45 50.4 Gy in 1.8 Gy per day, in addition to 10 - 16 Gy boost or 46 - 50 Gy in 2 Gy per day, in addition to 10 - 16 Gy boost, at the physician's discretion
Eligibility Criteria
You may qualify if:
- Adult female patients (18 to 75 years of age, inclusive);
- Patients diagnosed with ductal carcinoma in situ or non-inflammatory breast adenocarcinoma who have been referred for post-operative radiotherapy and have had no prior radiation treatment to that breast;
- Patients planning to undergo 3D conformal radiation therapy to the whole breast (as part of breast-conservation therapy / lumpectomy) or chest wall (as part of post-mastectomy irradiation), with or without treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary), using one of the following treatment schedules:
- Gy in 1.8 Gy per day, in addition to 10-16 Gy boost
- Gy in 2 Gy per day, in addition to 10-16 Gy boost;
- Patients who received breast-conservation therapy / lumpectomy must be receiving ≥ 107% of the total radiation dose (calculated from the total radiation dose including boost) to any portion of the breast, based on radiation inhomogeneity, and/or have a breast volume ≥ 1200 cc;
You may not qualify if:
- Patients with Stage T4 or Stage IV breast cancer;
- Patients with prior radiation therapy to the breast treated in this study;
- Patients with type V or VI skin according to the Fitzpatrick scale;
- Patients with bilateral breast cancer;
- Patients receiving partial breast irradiation therapy;
- Patients with uncontrolled diabetes (HbA1c \> 11.0%, historical values within 6 months of screening are acceptable);
- Patients with collagen vascular disease or vasculitis;
- Patients with concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- Patients with active bacterial, fungal or viral skin infections;
- Patients with known active hepatitis B or hepatitis C infection;
- Patients who intend to use any other topical cream, lotion or preparation applied to the radiation treatment area;
- Patients receiving concomitant chemotherapy during the course of the planned radiation treatment regimen. Patients are eligible if they are receiving sequential, neoadjuvant or adjuvant chemotherapy that is not anticipated to be delivered during the time course of the radiation treatment regimen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Ironwood Cancer and Research Centers
Mesa, Arizona, 85206, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Arizona Cancer Center
Scottsdale, Arizona, 85258, United States
University of Colorado Hospital, Dept. of Radiation Oncology
Aurora, Colorado, 80045, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
St. Vincent Anderson Regional Hospital Cancer Center
Anderson, Indiana, 46016, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Radiation Oncology Associates - Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Willis-Knighton Cancer Center
Shreveport, Louisiana, 71103, United States
University of Nebraska Medical Center - Eppley Cancer Center
Omaha, Nebraska, 68198, United States
CaroMont Health Comprehensive Cancer Center
Gastonia, North Carolina, 28054, United States
Sanford Health
Bismarck, North Dakota, 58501, United States
St. John Health System
Tulsa, Oklahoma, 74104, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Hughes Cancer Center
East Stroudsburg, Pennsylvania, 18301, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
21st Century Oncology - Carolina Regional Cancer Center
Myrtle Beach, South Carolina, 29577, United States
Spartanburg Regional Medical Center - Gibbs Cancer Center
Spartanburg, South Carolina, 29303, United States
Sanford Research/USD
Sioux Falls, South Dakota, 57104, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Mayo Clinic - LaCrosse
La Crosse, Wisconsin, 54601, United States
Columbia St. Mary's
Milwaukee, Wisconsin, 53211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- US Biogen Clinical Trial Center
- Organization
- Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2014
First Posted
May 20, 2014
Study Start
June 30, 2014
Primary Completion
April 30, 2015
Study Completion
April 30, 2015
Last Updated
June 3, 2025
Results First Posted
May 6, 2023
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/