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NCT02142959 · ClinicalTrials.gov registry record · Phase 2
RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 187
- Enrollment target
NCT02142959: Completed Phase 2 study, sponsored by Biogen.
NCT02142959 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 187 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02142959, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 187 participants
- Enrollment target
Study 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.
Primary Outcome
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, ski
Interventions
- DRUG Vehicle Lotion
- DRUG Omaveloxolone Lotion 0.5%
- DRUG Omaveloxolone Lotion 3%
- RADIATION 3D conformal radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2014-06-30 |
| Est. Completion | 2015-04-30 |
| Phase | Phase 2 |
What the finished NCT02142959 record still lists
NCT02142959 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 4 interventions - of which Vehicle Lotion is the first listed.
NCT02142959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02142959 about?
NCT02142959 is a clinical study titled "RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE". 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...
What is the current status of trial NCT02142959?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 187 participants. The study started on 2014-06-30. Estimated completion is 2015-04-30.
What interventions are being tested in trial NCT02142959?
The interventions under investigation include: Vehicle Lotion (DRUG), Omaveloxolone Lotion 0.5% (DRUG), Omaveloxolone Lotion 3% (DRUG), 3D conformal radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT02142959?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02142959's enrollment target sits among peer trials
187 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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