Trial Outcomes & Findings for RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE (NCT NCT02142959)
NCT ID: NCT02142959
Last Updated: 2025-06-03
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
187 participants
Primary outcome timeframe
Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported
Results posted on
2025-06-03
Participant Flow
Participant milestones
| Measure |
Omaveloxolone (RTA 408) Lotion 0.5%
Omaveloxolone 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%
Omaveloxolone 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
Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
62
|
61
|
|
Overall Study
COMPLETED
|
59
|
59
|
55
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
6
|
Reasons for withdrawal
| Measure |
Omaveloxolone (RTA 408) Lotion 0.5%
Omaveloxolone 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%
Omaveloxolone 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
Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
3
|
|
Overall Study
Administrative Reasons
|
1
|
0
|
1
|
|
Overall Study
Missing
|
0
|
1
|
0
|
|
Overall Study
Treatment changed from radiation treatment to chemo
|
0
|
0
|
1
|
|
Overall Study
Patient didn't complete end of study visit
|
0
|
0
|
1
|
Baseline Characteristics
RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
Baseline characteristics by cohort
| Measure |
Omaveloxolone (RTA 408) Lotion 0.5%
n=64 Participants
Omaveloxolone 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%
n=62 Participants
Omaveloxolone 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
n=61 Participants
Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
56 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
56.6 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
56.8 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
187 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
175 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
155 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
62 participants
n=107 Participants
|
61 participants
n=206 Participants
|
187 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reportedPopulation: Intent-to-treat population (all randomized patients whether or not they received study drug)
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
Outcome measures
| Measure |
Omaveloxolone (RTA 408) Lotion 0.5%
n=64 Participants
Omaveloxolone 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%
n=62 Participants
Omaveloxolone 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
n=61 Participants
Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
|
|---|---|---|---|
|
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
|
1.1 Grade
Interval 1.0 to 1.2
|
1.2 Grade
Interval 1.1 to 1.3
|
1.2 Grade
Interval 1.1 to 1.3
|
Adverse Events
Omaveloxolone (RTA 408) Lotion 0.5%
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Omaveloxolone (RTA 408) Lotion 3%
Serious events: 3 serious events
Other events: 54 other events
Deaths: 1 deaths
Vehicle Lotion
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omaveloxolone (RTA 408) Lotion 0.5%
n=64 participants at risk
Omaveloxolone 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%
n=62 participants at risk
Omaveloxolone 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
n=61 participants at risk
Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
Cardiac disorders
Cardiomyopathy
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/64
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
|
Infections and infestations
Incision site cellulitis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/64
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/64
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
0.00%
0/61
|
Other adverse events
| Measure |
Omaveloxolone (RTA 408) Lotion 0.5%
n=64 participants at risk
Omaveloxolone 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%
n=62 participants at risk
Omaveloxolone 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
n=61 participants at risk
Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.7%
3/64 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
0.00%
0/61
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
2/64 • Number of events 2
|
1.6%
1/62 • Number of events 1
|
4.9%
3/61 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
7.8%
5/64 • Number of events 5
|
4.8%
3/62 • Number of events 4
|
8.2%
5/61 • Number of events 5
|
|
General disorders
Asthenia
|
0.00%
0/64
|
0.00%
0/62
|
3.3%
2/61 • Number of events 2
|
|
General disorders
Axillary pain
|
4.7%
3/64 • Number of events 3
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
|
General disorders
Fatigue
|
42.2%
27/64 • Number of events 29
|
43.5%
27/62 • Number of events 27
|
42.6%
26/61 • Number of events 28
|
|
General disorders
Pain
|
4.7%
3/64 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/64
|
3.2%
2/62 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Breast infection
|
3.1%
2/64 • Number of events 2
|
0.00%
0/62
|
0.00%
0/61
|
|
Infections and infestations
Bronchitis
|
3.1%
2/64 • Number of events 2
|
4.8%
3/62 • Number of events 3
|
0.00%
0/61
|
|
Infections and infestations
Folliculitis
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Influenza
|
3.1%
2/64 • Number of events 2
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/64
|
4.8%
3/62 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.6%
1/64 • Number of events 1
|
0.00%
0/62
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
3.1%
2/64 • Number of events 2
|
1.6%
1/62 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
4/64 • Number of events 4
|
1.6%
1/62 • Number of events 1
|
3.3%
2/61 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
3.1%
2/64 • Number of events 2
|
3.2%
2/62 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
Injury, poisoning and procedural complications
Incision site pain
|
1.6%
1/64 • Number of events 1
|
4.8%
3/62 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma
|
3.1%
2/64 • Number of events 2
|
0.00%
0/62
|
0.00%
0/61
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
3/64 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/64
|
1.6%
1/62 • Number of events 1
|
4.9%
3/61 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.6%
1/64 • Number of events 1
|
4.8%
3/62 • Number of events 3
|
4.9%
3/61 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.1%
2/64 • Number of events 2
|
0.00%
0/62
|
0.00%
0/61
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/64
|
4.8%
3/62 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.8%
5/64 • Number of events 5
|
4.8%
3/62 • Number of events 3
|
3.3%
2/61 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
3.1%
2/64 • Number of events 2
|
4.8%
3/62 • Number of events 3
|
4.9%
3/61 • Number of events 3
|
|
Nervous system disorders
Headache
|
4.7%
3/64 • Number of events 3
|
3.2%
2/62 • Number of events 2
|
6.6%
4/61 • Number of events 5
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/64
|
0.00%
0/62
|
3.3%
2/61 • Number of events 2
|
|
Nervous system disorders
Sciatica
|
3.1%
2/64 • Number of events 2
|
0.00%
0/62
|
0.00%
0/61
|
|
Nervous system disorders
Sinus headache
|
4.7%
3/64 • Number of events 4
|
1.6%
1/62 • Number of events 1
|
0.00%
0/61
|
|
Psychiatric disorders
Anxiety
|
1.6%
1/64 • Number of events 1
|
3.2%
2/62 • Number of events 2
|
0.00%
0/61
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/64 • Number of events 1
|
3.2%
2/62 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
Reproductive system and breast disorders
Breast pain
|
31.2%
20/64 • Number of events 28
|
30.6%
19/62 • Number of events 27
|
29.5%
18/61 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
4/64 • Number of events 4
|
4.8%
3/62 • Number of events 4
|
9.8%
6/61 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/64 • Number of events 1
|
4.8%
3/62 • Number of events 3
|
0.00%
0/61
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/64
|
1.6%
1/62 • Number of events 1
|
3.3%
2/61 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.1%
2/64 • Number of events 2
|
0.00%
0/62
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/64
|
3.2%
2/62 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.2%
20/64 • Number of events 22
|
27.4%
17/62 • Number of events 19
|
19.7%
12/61 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/64 • Number of events 1
|
4.8%
3/62 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
2/64 • Number of events 2
|
3.2%
2/62 • Number of events 3
|
1.6%
1/61 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
29.7%
19/64 • Number of events 20
|
24.2%
15/62 • Number of events 15
|
29.5%
18/61 • Number of events 19
|
|
Vascular disorders
Hot flush
|
4.7%
3/64 • Number of events 3
|
6.5%
4/62 • Number of events 4
|
6.6%
4/61 • Number of events 4
|
|
Vascular disorders
Lymphoedema
|
1.6%
1/64 • Number of events 1
|
3.2%
2/62 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER