Dermatitis
Conditions
Keywords
ecofoam
Brief summary
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.
Detailed description
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
Interventions
DEVICERelizema 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
Sponsors
Relife S.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject's written informed consent obtained prior to any study-related procedures; 2. Generally healthy male and female aged ≥ 18 years; 3. Presence of atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD) of mild-moderateseverity: ▪ IGA score 2 (=mild) or 3 (=moderate); 4. Dermatitis affecting one or more body areas (face, legs, arms, etc.); 5. 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
1. Severe dermatitis at inclusion; 2. Pregnant and breastfeeding women; 3. Concomitant other skin disorders including skin infections; 4. Currently or previously diagnosed or treated (chemotherapy and/or radiotherapy) for cancer in the past 5 years; 5. History of previous skin cancer (history of non-metastatic squamous or basal cell carcinoma of the skin is allowed); 6. Active infections or use of antibiotics in the past 7 days; 7. Diabetic subjects; 8. History of congenital or acquired immunodepression; 9. Immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, any typology of lupus, rheumatoid arthritis) which could place the subject at risk or interfere with study results; 10. Use of any topic medication for dermatitis in the past 14 days; 11. Use of any topic product for dermatitis in the 2 days before study treatment start; 12. Any systemic treatment or procedure that could influence dermatitis activity within the past 30 days (or 5 half-lives); 13. Use of any corticosteroids, immunosuppressant drugs or immunotherapy within the past 30 days (or 5 half-lives); 14. Use of oral antihistamines and antidepressants in the past 30 days; 15. Subjects 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; 16. Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients; 17. Concomitant or previous participation in other interventional clinical study in the past 3 months; 18. Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Responded to Treatment With IGA Scale | after 28 days of treatment | The disease severity will be clinically measured through the Investigator Global Assessment (IGA is based on a five-point scale: 0 = clear 1. = almost clear 2. = mild 3= moderate 4 = severe) for dermatitis after 28 days of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Responded to Tretment | after 42 days of treatment | to evaluate the performance of the Relizema ecofoam in the change of dermatitis severity (IGAs based on a five-point scale: 0 = clear 1. = almost clear 2. = mild 3= moderate 4 = severe) after 42 days of treatment; |
| Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment | 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). |
| Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | 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) |
| Unit on a Scale | after 14, 28 and 42 days of treatment | 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) |
| to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam | at the end of the study ( day 42) | 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) |
| to Evaluate the Subject's Overall Acceptability of the Treatment | at the end of the study ( day 42)] | 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) |
| Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment | 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; |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Relizema Ecofoam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment Italy | 13 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 4 Participants |
| Subjects affected by mild-to-moderate atopic and contact (irritant or allergic) dermatitis | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
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 1. = almost clear 2. = mild 3= moderate 4 = severe) for dermatitis after 28 days of treatment.
Time frame: after 28 days of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relizema Ecofoam | Number of Participants Who Responded to Treatment With IGA Scale | 3 Participants |
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).
Time frame: after 14, 28 and 42 days of treatment
Population: to evaluate the eczema change
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relizema Ecofoam | Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment | after 14 days of treatment | 4.36 score on a scale | Standard Deviation 4.83 |
| Relizema Ecofoam | Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment | after 28 days of treatment | 2.21 score on a scale | Standard Deviation 2.34 |
| Relizema Ecofoam | Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment | after 42 days of treatment | 1.83 score on a scale | Standard Deviation 1.2 |
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 1. = almost clear 2. = mild 3= moderate 4 = severe) after 42 days of treatment;
Time frame: after 42 days of treatment
Population: Proportion of responders at visit 2 and visit 4, compared to baseline ( visit 1), visit 4 reported
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relizema Ecofoam | Number of Participants Who Responded to Tretment | 3 Participants |
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;
Time frame: after 14, 28 and 42 days of treatment
Population: DLQI score change from baseline (V1) to V2, V3 and V4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relizema Ecofoam | Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment | At visit 1 | 5.08 scores on a scale | Standard Deviation 3.58 |
| Relizema Ecofoam | Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment | After 14 days of treatment | 4.33 scores on a scale | Standard Deviation 3.25 |
| Relizema Ecofoam | Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment | After 28 days of treatment | 2.52 scores on a scale | Standard Deviation 3.05 |
| Relizema Ecofoam | Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment | After 42 days of treatment | 3.50 scores on a scale | Standard Deviation 2.26 |
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)
Time frame: at the end of the study ( day 42)
Population: Subject's and Investigator's global evaluation on performance of the study product
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Relizema Ecofoam | to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam | improved or minimally improved | 3 Participants |
| Relizema Ecofoam | to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam | no changes | 1 Participants |
| Relizema Ecofoam | to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam | minimally worse, worse or very much worse | 6 Participants |
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)
Time frame: at the end of the study ( day 42)]
Population: Subject's evaluation of overall acceptability with treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Relizema Ecofoam | to Evaluate the Subject's Overall Acceptability of the Treatment | satisfied | 6 Participants |
| Relizema Ecofoam | to Evaluate the Subject's Overall Acceptability of the Treatment | neither satisfied neither dissatisfied | 1 Participants |
| Relizema Ecofoam | to Evaluate the Subject's Overall Acceptability of the Treatment | dissatisfied | 3 Participants |
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)
Time frame: after 14, 28 and 42 days of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relizema Ecofoam | Unit on a Scale | between visit 1 and visit 2 | 91.38 units on a scale | Standard Deviation 17.1 |
| Relizema Ecofoam | Unit on a Scale | between visit 2 and visit 3 | 97.14 units on a scale | Standard Deviation 6.57 |
| Relizema Ecofoam | Unit on a Scale | between visit 3 and visit 4 | 90.67 units on a scale | Standard Deviation 15.52 |
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)
Time frame: after 14, 28 and 42 days of treatment
Population: VAS for pain, burning and itching rating
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for burning after 42 days of treatment | 27.71 scores on a scale | Standard Deviation 30.72 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for pain rating at Visit 1 | 13.42 scores on a scale | Standard Deviation 18.59 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for pian after 14 days of tratment | 15.33 scores on a scale | Standard Deviation 27.9 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for pian after 28 days of treatment | 8.71 scores on a scale | Standard Deviation 18.25 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for pain after 42 days of treatment | 20.83 scores on a scale | Standard Deviation 31.45 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for burning rating ai Visit 1 | 36.83 scores on a scale | Standard Deviation 36.8 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for burning after 14 days of treatment | 35 scores on a scale | Standard Deviation 37.67 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for burning after 28 days of treatment | 10.57 scores on a scale | Standard Deviation 18.12 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for itching ai visit 1 | 71.50 scores on a scale | Standard Deviation 26.89 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for itching after 14 days of treatment | 58.58 scores on a scale | Standard Deviation 40.27 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for itching after 28 days of treatment | 37.43 scores on a scale | Standard Deviation 32.91 |
| Relizema Ecofoam | Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment | VAS for itching after 42 days of treament | 52.17 scores on a scale | Standard Deviation 27.06 |