Trial Outcomes & Findings for Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients (NCT NCT05259774)
NCT ID: NCT05259774
Last Updated: 2025-03-28
Results Overview
The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle.
COMPLETED
NA
60 participants
28 days of treatment
2025-03-28
Participant Flow
Participant milestones
| Measure |
Relizema Cream
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
24
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients
Baseline characteristics by cohort
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
6.33 years
STANDARD_DEVIATION 4.97 • n=5 Participants
|
6.42 years
STANDARD_DEVIATION 4.45 • n=7 Participants
|
6.38 years
STANDARD_DEVIATION 4.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (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
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days of treatmentThe disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle.
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients.
|
17 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: after 14 and 42 days of treatment, 42 days reportedTo evaluate the performance of the Relizema cream, compared to placebo, in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate the Performance of the Relizema Cream, Compared to Placebo,
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: after 14, 28 and 42 days of treatment, reported after 42 daysTo evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate the Eczema Improvement
|
18 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: after 14, 28 and 42 days of treatment, day 42 reportedTo evaluate itching as reported by the patient at visits by the Numerical Rating Scale (NRS that is a numeric scale from 0 to 10, 0 is the best result, 10 is the worst), in the two treatment groups
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits
|
5.45 units on a scale
Standard Deviation 6.62
|
4.31 units on a scale
Standard Deviation 6.26
|
SECONDARY outcome
Timeframe: after 14, 28 and 42 days of treatment, reported 42 daysTo evaluate the QoL improvement of the patient related to his/her dermatitis, through the Children Dermatology Life Quality Index (CDLQI) questionnaire in the two treatment groups; The questionnaire asks for 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Global score: 0-1 = No effect on patient's life 2-5 = Small effect 6-10 = Moderate effect 11-20 = Very large effect 21-30 = Extremely large effect. The CDQLI was compiled by the patient at each visit. Young children were supported for the questionnaire compilation by the parents/guardian, if necessary)
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis
|
2.42 units on a scale
Standard Deviation 1.67
|
1.83 units on a scale
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: 42 daysPopulation: Treatment adherence was assessed by counting the applications reported in the patient's diary and dividing by the total number of applications. The percentage of applications applied is reported
Units on a scale of partecipants with an improvement in the dermatitis severity
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate the Patient's Adherence to Treatment
|
97.46 percentage of adherence
Standard Deviation 5.13
|
96.96 percentage of adherence
Standard Deviation 7.32
|
SECONDARY outcome
Timeframe: 42 days of treatmentTo evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare;
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare;
|
21 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: at the end of the study ( day 42)To evaluate the patient's global evaluation on performance of the study product performed by means of a 7-items scale (where 1 = very much improved, 2 = improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = worse, 7 = very much worse)
Outcome measures
| Measure |
Relizema Cream
n=25 Participants
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Relizema cram: Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
|
Vehicle
n=25 Participants
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
|
|---|---|---|
|
To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo
|
5.29 units on a scale
Standard Deviation 4.73
|
3.53 units on a scale
Standard Deviation 4
|
Adverse Events
Relizema Cream
Vehicle
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