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The scope of this open label clinical trial is to evaluate and confirm the performance of DermoRelizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology. 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 DermoRelizema 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 |
|---|---|---|---|
| DermoRelizema ecofoam | Experimental | DermoReizema ecofoam for 42 days, 2 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermoRelizema 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 Partecipants With Improvement of Dermatitis Severity | The primary endpoint was the change from baseline ( visit 1) to day 28 ( visit 3) in Investigator Global Assessment (IGA) and the assestment was also dichotomized in terms of treatment success or treatment failure | 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Partecipants With Improvement of the Dermatitis Severity | to evaluate the performance of the DermoRelizema ecofoam in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment; | after 14 and 42 days of treatment |
| Eczema Area and Severity Index Scores |
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Inclusion Criteria:
Subject's written informed consent obtained prior to any studyrelated procedures;
Generally healthy male and female aged ≥ 18 years;
Presence of dermatitis of any typology, including atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD), of mild-moderate severity:
Dermatitis affecting one or more body areas (face, legs, arms, etc.);
Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, 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:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriella Fabbrocini, MD | Ospedale "Federico II" Napoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria "Federico II" | Naples | Italia | 80138 | Italy |
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A total of 40 subject were enrolled in the study, signed the informed consent forms, attended the first visit and 40 started the treatment. Among them, 6 subjects withdrew from the study between V1 and V4 ( 3 subjects because they needed to start a not allowed medication, 2 were lost to follow-up and 1 withdrew the consent). Based on this, 34 subjects, out of 40, regularly completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | DermoRelizema Ecofoam | DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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 |
|
|
The demographic characteristics were analysed on FAS population
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| ID | Title | Description |
|---|---|---|
| BG000 | DermoReizema Ecofoam for 42 Days, 2 Times Per Day | DermoRelizema ecofoam is a topical compact mousse, to be applied 2 times per day, the first application in the morning and the second in the evening before bed time, for 42 consecutive days. |
| 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 Partecipants With Improvement of Dermatitis Severity | The primary endpoint was the change from baseline ( visit 1) to day 28 ( visit 3) in Investigator Global Assessment (IGA) and the assestment was also dichotomized in terms of treatment success or treatment failure | Primary endpoint data was analyzed in the FAS population and the analysis was then repeated in the PPAS population | Posted | Count of Participants | Participants | 28 days of treatment |
|
All subject enrolled were treated with DermoRelizema ecofoam for 42 consecutive days
Only two adverse event were registred during the study. This events were not related to the study treatment
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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 | DermoRelizema Ecofoam | DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | COVID 19 infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Coordinator | 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 | Yes | No | No | Study Protocol | Nov 6, 2020 | Nov 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 10, 2022 | Nov 10, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D003876 | Dermatitis, Atopic |
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
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Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
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to evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score. Severity strata for the EASI were as follows: 0 = clear; 01-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe |
| to 14, 28 and 42 days of treatment |
| VAS Scores for Itcing, Burning, Pain and Prurits at Visits | to evaluate the improvement in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale). The subject was requested to indicate at each visit his/her pruritus, itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). The rating was recorded as a distance from the left side of the scale (0 mm) to the mark made by the patient. | to 14, 28 and 42 days of treatment |
| Percentage of Partecipants With Improvement in the Quality of Life (QoL) | to evaluate improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index) questionnaire; 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 was 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. | to 14, 28 and 42 days of treatment |
| Number of Partecipants With Adherence to Treatment. | number of partecipants with adherence to treatment. | to 14, 28 and 42 days of treatment |
| Percentage of Patient With Improvement of Performance by IGA | to evaluate the subject's and Investigator's global evaluation of performance of DermoRelizema 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) |
| Percentage of Partecipants Who Indicated That the Treatment Was Acceptable | 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 |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of partecipants with clinical diagnosis of dermatitis of mild-moderate severity:IGA score 2-3 | IGA (Investigator Global Assessment) is a six-point scale (0 = clear, 1 = almost clear, 2 = mild, 3= moderate, 4 = severe, 5 = very severe. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Partecipants With Improvement of the Dermatitis Severity | to evaluate the performance of the DermoRelizema ecofoam in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment; | This endpoint was conducted on the FAS population | Posted | Count of Participants | Participants | after 14 and 42 days of treatment |
|
|
|
| Secondary | Eczema Area and Severity Index Scores | to evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score. Severity strata for the EASI were as follows: 0 = clear; 01-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe | EASI score change from baseline to every following time point | Posted | Mean | Standard Deviation | units on a scale | to 14, 28 and 42 days of treatment |
|
|
|
| Secondary | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | to evaluate the improvement in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale). The subject was requested to indicate at each visit his/her pruritus, itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). The rating was recorded as a distance from the left side of the scale (0 mm) to the mark made by the patient. | Change in ichting, burning, pain and prurits by VA from baseline to every following time point was analized using paired student's t-test if the variable is normally distribuited and wilcoxon signed rank test if the variabile is not normally distribuited. The subject was requested to indicate at each visit his/her pruritus, itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). . | Posted | Median | Standard Deviation | score on a scale | to 14, 28 and 42 days of treatment |
|
|
|
| Secondary | Percentage of Partecipants With Improvement in the Quality of Life (QoL) | to evaluate improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index) questionnaire; 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 was 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. | Not Posted | to 14, 28 and 42 days of treatment | Participants |
| Secondary | Number of Partecipants With Adherence to Treatment. | number of partecipants with adherence to treatment. | The subject's adherence to treatment was assessed through the number of applications reported on the subject's diary. | Posted | Number | number of partecipant | to 14, 28 and 42 days of treatment |
|
|
|
| Secondary | Percentage of Patient With Improvement of Performance by IGA | to evaluate the subject's and Investigator's global evaluation of performance of DermoRelizema 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) | Posted | Count of Participants | Participants | at the end of the study ( day 42) |
|
|
|
| Secondary | Percentage of Partecipants Who Indicated That the Treatment Was Acceptable | 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) | the acceptability was obteined by means of a 5 item scale will be summarized through number and the proportion of subject for each item | Posted | Number | percentage of participants | at the end of the study ( day 42) |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 2 |
| 40 |
| erythema with vesiculation and pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment | Worsening of clinical manifestations |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| after 42 days |
|
| Title | Measurements |
|---|---|
|
| itching at day 42 |
|
| burning at baseline |
|
| burning at day 14 |
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| burning at day 28 |
|
| burning at day 42 |
|
| pain at baseline |
|
| pain at day 14 |
|
| pain at day 28 |
|
| pain at day 42 |
|
| pruritus at baseline |
|
| pruritus at day 14 |
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| pruritus at day 28 |
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| pruritus at day 42 |
|