Atopic Dermatitis
Conditions
Keywords
cream, paediatric patients
Brief summary
The scope of this multicenter, double blind, randomized, vehicle-controlled clinical investigation is to evaluate and confirm the performance and safety of the Relizema cream in the improvement of the dermatitis severity in paediatric patients. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 42 days of treatment.
Detailed description
This is a Pre Market Study to evaluate and confirm the performance of the RelizemaTM cream in the improvement of the dermatitis severity, assessed through a clinical parameter, the Investigator's Global Assessment (IGA) at baseline and at Visit 3, compared to vehicle. To evaluate the performance of the RelizemaTM cream, compared to placebo in the eczema improvement through the EASI. The safety objectives is to evaluate the local and general tolerability of Relizema cream compared to placebo.
Interventions
DEVICERelizema 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.
Sponsors
Relife S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The patients will be randomly allocated to one of the following treatment groups: Relizema cream and vehicle
Intervention model description
multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Release of the written informed consent obtained prior to any study-related procedures, by both the parents/the guardian; * Male and female infants, children, adolescent aged between 6 months and 16 years, inclusive; * Presence of atopic dermatitis (AD) of mild-moderate severity: * IGA score 2 (=mild) or * IGA score 3 (=moderate) * Patients with a baseline score for itch at least 4 on the NRS * Patients/parents/guardian able to comprehend the full nature and the purpose of the investigation, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement
Exclusion criteria
* Severe dermatitis at inclusion; * Pregnant and breastfeeding patients; * Concomitant other skin disorders including skin infections; * Use of antibiotics in the past 7 days; * History of congenital or acquired immunodepression; * Immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, any typology of lupus, rheumatoid arthritis) which could place the patient at risk or interfere with study results; * Use of any topic or systemic drug for dermatitis in the past 10 days; * Use of any topic emollient product for dermatitis in the 2 days before study treatment start; * Any systemic treatment or procedure that could influence dermatitis activity within the past 30 days (or 5 half-lives); * Use of any corticosteroids, immunosuppressant drugs or immunotherapy within the past 30 days (or 5 half-lives); * Use of oral antihistamines and antidepressants in the past 30 days; * Patients with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations; * Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients; * Concomitant or previous participation in other interventional clinical study in the past 3 months; * Patients planning sun exposure or tanning booths or UV sources throughout the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients. | 28 days of treatment | The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Eczema Improvement | after 14, 28 and 42 days of treatment, reported after 42 days | To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score |
| To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits | after 14, 28 and 42 days of treatment, day 42 reported | To 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 |
| To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis | after 14, 28 and 42 days of treatment, reported 42 days | To 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) |
| To Evaluate the Performance of the Relizema Cream, Compared to Placebo, | after 14 and 42 days of treatment, 42 days reported | To evaluate the performance of the Relizema cream, compared to placebo, in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment |
| To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare; | 42 days of treatment | To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare; |
| To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo | 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) |
| To Evaluate the Patient's Adherence to Treatment | 42 days | Units on a scale of partecipants with an improvement in the dermatitis severity |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Vehicle Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Relizema Cream | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.33 years STANDARD_DEVIATION 4.97 | 6.42 years STANDARD_DEVIATION 4.45 | 6.38 years STANDARD_DEVIATION 4.71 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 25 Participants | 50 Participants |
| Region of Enrollment Italy | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients.
The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle.
Time frame: 28 days of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relizema Cream | To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients. | 17 Participants |
| Vehicle | To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients. | 13 Participants |
Secondary
To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis
To 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)
Time frame: after 14, 28 and 42 days of treatment, reported 42 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relizema Cream | 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 |
| Vehicle | To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis | 1.83 units on a scale | Standard Deviation 1.86 |
Secondary
To Evaluate the Eczema Improvement
To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
Time frame: after 14, 28 and 42 days of treatment, reported after 42 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relizema Cream | To Evaluate the Eczema Improvement | 18 Participants |
| Vehicle | To Evaluate the Eczema Improvement | 14 Participants |
Secondary
To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits
To 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
Time frame: after 14, 28 and 42 days of treatment, day 42 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relizema Cream | To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits | 5.45 units on a scale | Standard Deviation 6.62 |
| Vehicle | To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits | 4.31 units on a scale | Standard Deviation 6.26 |
Secondary
To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare;
To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare;
Time frame: 42 days of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relizema Cream | To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare; | 21 Participants |
| Vehicle | To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare; | 16 Participants |
Secondary
To Evaluate the Patient's Adherence to Treatment
Units on a scale of partecipants with an improvement in the dermatitis severity
Time frame: 42 days
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relizema Cream | To Evaluate the Patient's Adherence to Treatment | 97.46 percentage of adherence | Standard Deviation 5.13 |
| Vehicle | To Evaluate the Patient's Adherence to Treatment | 96.96 percentage of adherence | Standard Deviation 7.32 |
Secondary
To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo
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)
Time frame: at the end of the study ( day 42)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relizema Cream | 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 |
| Vehicle | To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo | 3.53 units on a scale | Standard Deviation 4 |
Secondary
To Evaluate the Performance of the Relizema Cream, Compared to Placebo,
To evaluate the performance of the Relizema cream, compared to placebo, in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment
Time frame: after 14 and 42 days of treatment, 42 days reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relizema Cream | To Evaluate the Performance of the Relizema Cream, Compared to Placebo, | 12 Participants |
| Vehicle | To Evaluate the Performance of the Relizema Cream, Compared to Placebo, | 10 Participants |