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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration
AOU Policlinico "G. Rodolico- San Marco"
Catania, Italia, Italy
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
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
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
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
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
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)
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)]