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The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 28 days of treatment.
The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology. The product will be applied for 42 days of treatment, 2 times per day into the face.
The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relizema ecofoam | Experimental | Reizema ecofoam for 42 days, 2 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relizema ecofoam | Device | DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Responded to Treatment With IGA Scale | The disease severity will be clinically measured through the Investigator Global Assessment (IGA is based on a five-point scale: 0 = clear
4 = severe) for dermatitis after 28 days of treatment. | after 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Responded to Tretment | to evaluate the performance of the Relizema ecofoam in the change of dermatitis severity (IGAs based on a five-point scale: 0 = clear
4 = severe) after 42 days of treatment; | after 42 days of treatment |
| Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Micali | AOU Policlinico "G. Rodolico-San Marco" Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico "G. Rodolico- San Marco" | Catania | Italia | 95123 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Relizema Ecofoam | Reizema ecofoam for 42 days, 2 times per day Relizema ecofoam: DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Relizema Ecofoam | Reizema ecofoam for 42 days, 2 times per day Relizema ecofoam: DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration |
| 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 | Number of Participants Who Responded to Treatment With IGA Scale | The disease severity will be clinically measured through the Investigator Global Assessment (IGA is based on a five-point scale: 0 = clear
4 = severe) for dermatitis after 28 days of treatment. | Posted | Count of Participants | Participants | after 28 days of treatment |
|
|
42 days
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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 Ecofoam | Reizema ecofoam for 42 days, 2 times per day Relizema ecofoam: DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Giuseppe Micali | 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 | Jun 9, 2023 | May 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
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to evaluate the eczema change through the EASI (Eczema Area and Severity Index Four body regions are considered: head and neck, trunk (including genital area), upper limbs, lower limbs (including buttocks). The percentage of skin affected by eczema in each region is correlated to an area score (0 = 0: no eczema in this region, best result; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%: the entire region is affected by eczema, worst result). |
| after 14, 28 and 42 days of treatment |
| Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | to evaluate the change in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale) The subject will be requested to indicate at each visit his/her itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). (0: best result, 100mm:worst result) | after 14, 28 and 42 days of treatment |
| Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment | to evaluate change in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index DLQI is a questionnaire used to measure the impact of skin disease on the quality of life of an affected person. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, 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 DQLI will be compiled by the subject at each visit.) questionnaire; | after 14, 28 and 42 days of treatment |
| Unit on a Scale | to evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability (100% is the best result, 0% is the worst) | after 14, 28 and 42 days of treatment |
| to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam | to evaluate the subject's and Investigator's global evaluation of performance of Relizema ecofoam 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) |
| to Evaluate the Subject's Overall Acceptability of the Treatment | to evaluate the subject's overall acceptability of the treatment (which takes into account pleasant or unpleasant feeling with the product and the ease of use), performed by means of a 5-item scale (where 1 = very much satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very much dissatisfied) | at the end of the study ( day 42)] |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Subjects affected by mild-to-moderate atopic and contact (irritant or allergic) dermatitis | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants Who Responded to Tretment | to evaluate the performance of the Relizema ecofoam in the change of dermatitis severity (IGAs based on a five-point scale: 0 = clear
4 = severe) after 42 days of treatment; | Proportion of responders at visit 2 and visit 4, compared to baseline ( visit 1), visit 4 reported | Posted | Count of Participants | Participants | after 42 days of treatment |
|
|
|
| Secondary | Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment | to evaluate the eczema change through the EASI (Eczema Area and Severity Index Four body regions are considered: head and neck, trunk (including genital area), upper limbs, lower limbs (including buttocks). The percentage of skin affected by eczema in each region is correlated to an area score (0 = 0: no eczema in this region, best result; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%: the entire region is affected by eczema, worst result). | to evaluate the eczema change | Posted | Mean | Standard Deviation | score on a scale | after 14, 28 and 42 days of treatment |
|
|
|
| Secondary | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | to evaluate the change in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale) The subject will be requested to indicate at each visit his/her itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). (0: best result, 100mm:worst result) | VAS for pain, burning and itching rating | Posted | Mean | Standard Deviation | scores on a scale | after 14, 28 and 42 days of treatment |
|
|
|
| Secondary | Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment | to evaluate change in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index DLQI is a questionnaire used to measure the impact of skin disease on the quality of life of an affected person. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, 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 DQLI will be compiled by the subject at each visit.) questionnaire; | DLQI score change from baseline (V1) to V2, V3 and V4. | Posted | Mean | Standard Deviation | scores on a scale | after 14, 28 and 42 days of treatment |
|
|
|
| Secondary | Unit on a Scale | to evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability (100% is the best result, 0% is the worst) | Posted | Mean | Standard Deviation | units on a scale | after 14, 28 and 42 days of treatment |
|
|
|
| Secondary | to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam | to evaluate the subject's and Investigator's global evaluation of performance of Relizema ecofoam 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) | Subject's and Investigator's global evaluation on performance of the study product | Posted | Count of Participants | Participants | at the end of the study ( day 42) |
|
|
|
| Secondary | to Evaluate the Subject's Overall Acceptability of the Treatment | to evaluate the subject's overall acceptability of the treatment (which takes into account pleasant or unpleasant feeling with the product and the ease of use), performed by means of a 5-item scale (where 1 = very much satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very much dissatisfied) | Subject's evaluation of overall acceptability with treatment | Posted | Count of Participants | Participants | at the end of the study ( day 42)] |
|
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| Title | Measurements |
|---|---|
|
|
| VAS for pain after 42 days of treatment |
|
| VAS for burning rating ai Visit 1 |
|
| VAS for burning after 14 days of treatment |
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| VAS for burning after 28 days of treatment |
|
| VAS for burning after 42 days of treatment |
|
| VAS for itching ai visit 1 |
|
| VAS for itching after 14 days of treatment |
|
| VAS for itching after 28 days of treatment |
|
| VAS for itching after 42 days of treament |
|
| Title | Measurements |
|---|---|
|
| After 42 days of treatment |
|
| Title | Measurements |
|---|---|
|