Trial Outcomes & Findings for Silverlon to Reduce Radiation Dermatitis (NCT NCT04238728)

NCT ID: NCT04238728

Last Updated: 2024-01-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 31 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-01-05

Participant Flow

111 patient screened. 41 were ineligible. 31 were not approached because they already started radiation therapy or were undergoing chemotherapy or surgery. 39 were approached. 1 screen failed and 31 consented and started the intervention.

Participant milestones

Measure	Silverlon Arm Silverlon: silver nylon dressing will be applied daily
Overall Study STARTED	31
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Silverlon Arm Silverlon: silver nylon dressing will be applied daily
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

Silverlon to Reduce Radiation Dermatitis

Baseline characteristics by cohort

Measure	Silverlon Arm n=31 Participants Silverlon: silver nylon dressing will be applied daily
Age, Continuous	57.6 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Silverlon Arm n=28 Participants Silverlon: silver nylon dressing will be applied daily
Number of Participants With an Adverse Skin Event	1 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: 30 patients completed the 2 week timepoint of the study.

The radiation oncologist or nurse will rate the skin reaction in the area where Silverlon dressing was applied using the RTOG scale which ranges from 0-5 with higher scores indicating worse outcome.

Grade 0 No change; Normal Skin Grade 1 Faint erythema; dry desquamation; epilation, decreased sweating Grade 2 Tender or bright erythema; moderate edema; patchy moist desquamation only in skin folds.

Grade 3 Confluent moist desquamation in areas other than skin folds; pitting edema Grade 4 Ulceration; hemorrhage; necrosis

Outcome measures

Measure	Silverlon Arm n=30 Participants Silverlon: silver nylon dressing will be applied daily
Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score Grade 1	20 Participants
Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score Grade 2	9 Participants
Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score Grade 3	0 Participants
Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score Grade 4	0 Participants
Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score Grade 0	1 Participants

SECONDARY outcome

Timeframe: Mid study-visit, approximately 2 weeks

This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale (HPAS) individually scores the extent and severity of erythema, dry desquamation, moist desquamation, and necrosis using a 5-point scale from 0 to 4. Erythema is rated based on the degree of color change. Dry desquamation, moist desquamation, and necrosis are rated based on the percentage of the treatment area affected by that particular reaction. The HPAS score can range between 0 to 16. The patient symptom scale focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The patient symptom scale can range between 4 to 16. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The total skin reaction score can range between 4 to 32. The higher the score, the worse the skin reaction.

Outcome measures

Measure	Silverlon Arm n=30 Participants Silverlon: silver nylon dressing will be applied daily
Mean Radiation Induced Skin Reaction Assessment Scale	6.31 score on a scale Interval 5.47 to 6.94

SECONDARY outcome

Timeframe: End of radiation therapy, approximately 4.5 weeks

This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale (HAPS) individually scores the extent and severity of erythema, dry desquamation, moist desquamation, and necrosis using a 5-point scale from 0 to 4. Erythema is rated based on the degree of color change. Dry desquamation, moist desquamation, and necrosis are rated based on the percentage of the treatment area affected by that particular reaction. The HPAS score can range between 0 to 16. The patient symptom scale focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The patient symptom scale can range between 4 to 16. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The total skin reaction score can range between 4 to 32. The higher the score, the worse the skin reaction.

Outcome measures

Measure	Silverlon Arm n=30 Participants Silverlon: silver nylon dressing will be applied daily
Mean Radiation Induced Skin Reaction Assessment Scale	10.77 score on a scale Interval 9.28 to 12.25

SECONDARY outcome

Timeframe: 2 weeks post radiation therapy, approximately 6.5 weeks

This scoring system contains both a healthcare professions assessment scale and a patient symptom scale. The healthcare professional assessment scale (HPAS) individually scores the extent and severity of erythema, dry desquamation, moist desquamation, and necrosis using a 5-point scale from 0 to 4. Erythema is rated based on the degree of color change. Dry desquamation, moist desquamation, and necrosis are rated based on the percentage of the treatment area affected by that particular reaction. The HPAS score can range between 0 to 16. The patient symptom scale focuses on skin tenderness, itching, burning, and functional activity using a 4-point scale from 1 to 4. The patient symptom scale can range between 4 to 16. The Healthcare Professional Assessment Scale scores and the Patient Symptom Scale scores are added together for a total skin reaction score. The total skin reaction score can range between 4 to 32. The higher the score, the worse the skin reaction.

Outcome measures

Measure	Silverlon Arm n=30 Participants Silverlon: silver nylon dressing will be applied daily
Mean Radiation Induced Skin Reaction Assessment Scale	8.63 score on a scale Interval 7.39 to 9.87

Adverse Events

Silverlon Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Silverlon Arm n=31 participants at risk Silverlon: silver nylon dressing will be applied daily
Skin and subcutaneous tissue disorders open area in inframammary fold	3.2% 1/31 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Julie Ryan, MD

University of Rochester Medical Center

Phone: 585-276-3862

Email: Julie_Ryan@URMC.Rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place