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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relizema cream | Experimental | Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
|
| Vehicle | No Intervention | Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relizema cram | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | after 14 and 42 days of treatment, 42 days reported |
| To Evaluate the Eczema Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Stingeni | Santa Maria della Misericordia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luca Stingeni | Perugia | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Vehicle | Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients were divided into 3 groups: infants from 6 months to 2 years, children from 3 to 11 years and adolescents from 12 to 16 years inclusive.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 28 days of treatment |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lia Fabbri | Relife Srl | 05556809528 | lfabbri@relifecompany.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | Nov 15, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2021 | Feb 12, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation
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The patients will be randomly allocated to one of the following treatment groups: Relizema cream and vehicle
|
To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score |
| after 14, 28 and 42 days of treatment, reported after 42 days |
| 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 | after 14, 28 and 42 days of treatment, day 42 reported |
| 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) | after 14, 28 and 42 days of treatment, reported 42 days |
| To Evaluate the Patient's Adherence to Treatment | Units on a scale of partecipants with an improvement in the dermatitis severity | 42 days |
| 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; | 42 days of treatment |
| 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) | at the end of the study ( day 42) |
| BG001 | Vehicle | Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Vehicle |
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
|
|
| 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 | Posted | Count of Participants | Participants | after 14 and 42 days of treatment, 42 days reported |
|
|
|
| Secondary | To Evaluate the Eczema Improvement | To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score | Posted | Count of Participants | Participants | after 14, 28 and 42 days of treatment, reported after 42 days |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | after 14, 28 and 42 days of treatment, day 42 reported |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | after 14, 28 and 42 days of treatment, reported 42 days |
|
|
|
| Secondary | To Evaluate the Patient's Adherence to Treatment | Units on a scale of partecipants with an improvement in the dermatitis severity | 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 | Posted | Mean | Standard Deviation | percentage of adherence | 42 days |
|
|
|
| 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; | Posted | Count of Participants | Participants | 42 days of treatment |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | at the end of the study ( day 42) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Vehicle | Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |