NCT04238728

Silverlon to Reduce Radiation Dermatitis

Completed Phase 1 Results posted Last updated 5 January 2024

What this trial tests

Phase 1 trial testing Silverlon in Radiation Dermatitis in 31 participants. Completed in 25 March 2022.

Timeline

31 August 2020

Primary endpoint
1 March 2022

25 March 2022

Quick facts

Lead sponsor	University of Rochester
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	31
Start date	31 August 2020
Primary completion	1 March 2022
Estimated completion	25 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Silverlon

Conditions studied

• Radiation Dermatitis — all drugs for Radiation Dermatitis →

Sponsor

University of Rochester

Who can join

22 and older, female only, with Radiation Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With an Adverse Skin Event Primary · 12 weeks

Group	Value	95% CI
Silverlon Arm	1

Number of Participants With Each Grade of the Radiation Therapy Oncology Group (RTOG) Toxicity Score Secondary · 2 weeks

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

Grade 0

Group	Value	95% CI
Silverlon Arm	1

Grade 1

Group	Value	95% CI
Silverlon Arm	20

Grade 2

Group	Value	95% CI
Silverlon Arm	9

Grade 3

Group	Value	95% CI
Silverlon Arm	0

Grade 4

Group	Value	95% CI
Silverlon Arm	0

Mean Radiation Induced Skin Reaction Assessment Scale Secondary · 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, itch

Group	Value	95% CI
Silverlon Arm	6.31	5.47 – 6.94

Mean Radiation Induced Skin Reaction Assessment Scale Secondary · 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, itch

Group	Value	95% CI
Silverlon Arm	10.77	9.28 – 12.25

Mean Radiation Induced Skin Reaction Assessment Scale Secondary · 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, itch

Group	Value	95% CI
Silverlon Arm	8.63	7.39 – 9.87

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Silverlon Arm

Serious: 1/31 (3%)

Deaths: 0/31

Serious adverse events (1 terms)

Reaction	System	Silverlon Arm
open area in inframammary fold	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: open area in inframammary fold.

Data from ClinicalTrials.gov NCT04238728 adverse events section.

Sponsor's own description

The purpose of this study is to see if a silver-nylon dressing (Silverlon®, Argentum Medical) is useful for the prevention or treatment of radiation dermatitis in patients receiving radiation therapy to the breast.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Review of the Terminology Describing Ionizing Radiation-Induced Skin Injury: A Case for Standardization.
   Burnett LR, Hughes RT, Rejeski AF, Moffatt LT, et al · · 2021 · cited 12× · PMID 34613833 · DOI 10.1177/15330338211039681
2. Radiation-induced skin reactions: oxidative damage mechanism and antioxidant protection.
   Liu C, Wei J, Wang X, Zhao Q, et al · · 2024 · cited 8× · PMID 39450273 · DOI 10.3389/fcell.2024.1480571
3. Overlapping Science in Radiation and Sulfur Mustard Exposures of Skin and Lung: Consideration of Models, Mechanisms, Organ Systems, and Medical Countermeasures: Overlapping science in radiation and sulfur mustard injuries to lung and skin.
   Satyamitra MM, Andres DK, Bergmann JN, Hoffman CM, et al · · 2023 · PMID 37852927 · DOI 10.1017/dmp.2023.176