Trial Outcomes & Findings for Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis. (NCT NCT04483856)
NCT ID: NCT04483856
Last Updated: 2025-05-15
Results Overview
Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
two weeks after the last RT sessiont,day 35-42
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
DermoRelizema Cream
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
31
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
Baseline characteristics by cohort
| Measure |
DermoRelizema Cream
n=31 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=30 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
59.11 years
STANDARD_DEVIATION 10.86 • n=5 Participants
|
59.56 years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
59.34 years
STANDARD_DEVIATION 10.15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: two weeks after the last RT sessiont,day 35-42Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity
Outcome measures
| Measure |
DermoRelizema Cream
n=35 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=35 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Number of Participants With Progression of Radio Therapy Induced Skin Reaction
|
35 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 561\. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4)
Outcome measures
| Measure |
DermoRelizema Cream
n=30 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=31 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
|
27 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Number of patients that are better on the radiation symptoms reported by the patient in a diary
Evaluation of dermatitis symptoms management
Outcome measures
| Measure |
DermoRelizema Cream
n=30 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=31 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)
pain
|
15.56 units on a scale
Standard Deviation 15.58
|
17.90 units on a scale
Standard Deviation 14.05
|
|
Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)
itch
|
14.42 units on a scale
Standard Deviation 10.29
|
15.79 units on a scale
Standard Deviation 10.81
|
|
Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)
burning
|
15.53 units on a scale
Standard Deviation 11.97
|
12.65 units on a scale
Standard Deviation 10.21
|
|
Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)
tenderness
|
8 units on a scale
Standard Deviation 9.28
|
12.96 units on a scale
Standard Deviation 9.58
|
SECONDARY outcome
Timeframe: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)Population: Evaluation of the severity of radiation dermatitis by the investigator
Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC (system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer(grade 0-1: treatment is succesfull, grade 1 or magior: treatment insuccesful) ), at visits 2, 3 and 4
Outcome measures
| Measure |
DermoRelizema Cream
n=31 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=28 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V2 no erythema
|
9 Participants
|
2 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V2 erythema grade 1
|
18 Participants
|
24 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V2 erythema grade 2
|
4 Participants
|
1 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V2 erythema grade 3
|
0 Participants
|
1 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V3 no erythema
|
16 Participants
|
9 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V3 erythema grade 1
|
13 Participants
|
18 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V3 erythema grade 3
|
1 Participants
|
1 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V4 no erythema
|
29 Participants
|
25 Participants
|
|
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
V4 erythema grade1
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)Population: Evaluation of the severity of radiation dermatitis by the investigator
Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale. The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin ( grade 0: best result, grade 4§: worst result)
Outcome measures
| Measure |
DermoRelizema Cream
n=30 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=28 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale
V1 skin healthy
|
30 Participants
|
28 Participants
|
|
Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale
V4 grade 0
|
29 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)Population: instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters
Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,
Outcome measures
| Measure |
DermoRelizema Cream
n=30 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=28 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Number of Participants With Progression of Radio Therapy Induced Skin Reaction
|
30 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: patient's opinion on the products' pleasantness
Overall patient's opinion on the products' pleasantness
Outcome measures
| Measure |
DermoRelizema Cream
n=30 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=28 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Patient Opinion on Cream With a Likert Scale
smell pleasant/very pleasant
|
18 Participants
|
15 Participants
|
|
Patient Opinion on Cream With a Likert Scale
texture pleasant/very pleasant
|
30 Participants
|
27 Participants
|
|
Patient Opinion on Cream With a Likert Scale
spreadability pleasant/very pleasant
|
30 Participants
|
28 Participants
|
|
Patient Opinion on Cream With a Likert Scale
satisfaction pleasant/very pleasant
|
29 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Patient's adherence to treatment
Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst)
Outcome measures
| Measure |
DermoRelizema Cream
n=31 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=28 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Adherence to Treatment of Patients
|
96.50 units on a scale
Standard Deviation 7.98
|
97.50 units on a scale
Standard Deviation 8.82
|
SECONDARY outcome
Timeframe: up to 1 yearPopulation: Adverse Events
Occurrence of Adverse Events
Outcome measures
| Measure |
DermoRelizema Cream
n=31 Participants
The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
|
Dexeryl
n=28 Participants
The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
|
|---|---|---|
|
Occurrence of Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
DermoRelizema Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexeryl
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place