Dermatitis
Conditions
Keywords
ecofoam, DermoRelizema ecofoam, dermatitis treatment, mild moderate dermatitis, atopic dermatitis, contact dermatitis
Brief summary
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.
Detailed description
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
Interventions
DEVICEDermoRelizema 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 studyrelated procedures; 2. Generally healthy male and female aged ≥ 18 years; 3. Presence of dermatitis of any typology, including atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD), of mild-moderate severity: * 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 Partecipants With Improvement of Dermatitis Severity | 28 days of treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index Scores | to 14, 28 and 42 days of treatment | 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 |
| VAS Scores for Itcing, Burning, Pain and Prurits at Visits | to 14, 28 and 42 days of treatment | 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. |
| Percentage of Partecipants With Improvement in the Quality of Life (QoL) | to 14, 28 and 42 days of treatment | 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. |
| Percentage of Partecipants With Improvement of the Dermatitis Severity | after 14 and 42 days of treatment | to evaluate the performance of the DermoRelizema ecofoam in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment; |
| Percentage of Patient With Improvement of Performance by IGA | at the end of the study ( day 42) | 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) |
| Percentage of Partecipants Who Indicated That the Treatment Was Acceptable | 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) |
| Number of Partecipants With Adherence to Treatment. | to 14, 28 and 42 days of treatment | number of partecipants with adherence to treatment. |
Countries
Italy
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DermoReizema Ecofoam for 42 Days, 2 Times Per Day |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Number of partecipants with clinical diagnosis of dermatitis of mild-moderate severity:IGA score 2-3 | 37 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 | 37 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Italy | 37 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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
Time frame: 28 days of treatment
Population: Primary endpoint data was analyzed in the FAS population and the analysis was then repeated in the PPAS population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermoRelizema Ecofoam | Number of Partecipants With Improvement of Dermatitis Severity | 37 Participants |
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
Time frame: to 14, 28 and 42 days of treatment
Population: EASI score change from baseline to every following time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DermoRelizema Ecofoam | Eczema Area and Severity Index Scores | after 14 days | 1.20 units on a scale | Standard Deviation 1.03 |
| DermoRelizema Ecofoam | Eczema Area and Severity Index Scores | after 28 days | 0.80 units on a scale | Standard Deviation 1.32 |
| DermoRelizema Ecofoam | Eczema Area and Severity Index Scores | baseline | 2.60 units on a scale | Standard Deviation 1.94 |
| DermoRelizema Ecofoam | Eczema Area and Severity Index Scores | after 42 days | 0.20 units on a scale | Standard Deviation 1.33 |
Secondary
Number of Partecipants With Adherence to Treatment.
number of partecipants with adherence to treatment.
Time frame: to 14, 28 and 42 days of treatment
Population: The subject's adherence to treatment was assessed through the number of applications reported on the subject's diary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DermoRelizema Ecofoam | Number of Partecipants With Adherence to Treatment. | 36 number of partecipant |
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)
Time frame: at the end of the study ( day 42)
Population: the acceptability was obteined by means of a 5 item scale will be summarized through number and the proportion of subject for each item
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DermoRelizema Ecofoam | Percentage of Partecipants Who Indicated That the Treatment Was Acceptable | 83.8 percentage of participants |
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.
Time frame: to 14, 28 and 42 days of treatment
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;
Time frame: after 14 and 42 days of treatment
Population: This endpoint was conducted on the FAS population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermoRelizema Ecofoam | Percentage of Partecipants With Improvement of the Dermatitis Severity | 35 Participants |
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)
Time frame: at the end of the study ( day 42)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermoRelizema Ecofoam | Percentage of Patient With Improvement of Performance by IGA | 36 Participants |
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.
Time frame: to 14, 28 and 42 days of treatment
Population: 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). .
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | itching at day 42 | 16.46 score on a scale | Standard Deviation 0 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | burning at baseline | 24.00 score on a scale | Standard Deviation 27.24 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pruritus at day 14 | 24.00 score on a scale | Standard Deviation 26.98 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pruritus at day 28 | 10.00 score on a scale | Standard Deviation 15.24 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | itching at baseline | 32.00 score on a scale | Standard Deviation 30.09 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | itching at day 14 | 17.00 score on a scale | Standard Deviation 23.29 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | itching at day 28 | 3.00 score on a scale | Standard Deviation 12.33 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | burning at day 14 | 18.40 score on a scale | Standard Deviation 10.5 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | burning at day 28 | 8.69 score on a scale | Standard Deviation 2 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | burning at day 42 | 0.00 score on a scale | Standard Deviation 11.95 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pain at baseline | 4.00 score on a scale | Standard Deviation 20.29 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pain at day 14 | 0.00 score on a scale | Standard Deviation 12.58 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pain at day 28 | 0.00 score on a scale | Standard Deviation 12.17 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pain at day 42 | 0.00 score on a scale | Standard Deviation 4.43 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pruritus at baseline | 52.00 score on a scale | Standard Deviation 31.6 |
| DermoRelizema Ecofoam | VAS Scores for Itcing, Burning, Pain and Prurits at Visits | pruritus at day 42 | 1.00 score on a scale | Standard Deviation 19.38 |