The goal of this clinical study is to determine whether URGO FilmoCream Eczema is effective as a non-steroidal treatment to relieve symptoms of atopic dermatitis. It also aims to evaluate the cream's ability to moisturize, soothe irritation, protect the skin, and promote healing of eczema lesions. The main questions the study seeks to answer are: 1. Does URGO FilmoCream Eczema improve symptom relief of atopic dermatitis when used alongside standard topical corticosteroid treatment? 2. How do eczema lesions treated with topical corticosteroids alone progress and heal compared to those treated with topical corticosteroids plus URGO FilmoCream Eczema? To investigate this, patients with at least two similar eczema lesions are enrolled. One lesion is treated with topical corticosteroids alone, while the other is treated with topical corticosteroids plus URGO FilmoCream Eczema. The progression of both lesions is monitored throughout treatment, until healing, and for 28 days after the last application of topical corticosteroids.
This study has two parts. 1\. Treatment phase (up to 30 days): * For the lesions treated with the combination of both products, URGO FilmoCream Eczema is applied at least twice a day, in the morning and evening. In the evening, it is applied after topical corticosteroid (Desonide 0.1% or, if needed, betamethasone 0.05%). * For the lesion treated with topical corticosteroid only: treatment starts with Desonide 0.1% and may switch to betamethasone 0.05% if needed. This part lasts until the skin is fully healed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Until lesion resolution, for a maximum of 30 consecutive days Treatment with dermocorticoids - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required.
Until lesion resolution, for a maximum of 30 consecutive days URGO FilmoCream Eczema is applied at least twice daily (morning and evening) in a thin layer over the entire surface of the selected lesion, extending 1 cm beyond the edges, and left to dry for about 30 seconds to form a protective film. Reapplication is allowed if the film is disturbed (e.g., due to water exposure), with a maximum of 20 pump pressures per day. In the evening, it is applied after the dermocorticoid - desonide 0.1%, or betamethasone 0.05% in case treatment escalation is required.
During the 28-day follow-up period, in case of relapse, URGO FilmoCream Eczema is reapplied twice daily (morning and evening). If there is no improvement or worsening, the combined treatment must be reinitiated under the same conditions as during the treatment period.
During the 28-day follow-up period, in case of relapse, start with desonide 0.1%, escalate to betamethasone 0.05% if necessary.
Eurofins Dermscan Poland
Gdansk, Poland
Private Practice
Malbork, Poland
Change from baseline in local SCORAD Index at end of treatment
The local SCORAD Index includes the intensity part of SCORAD (SCORing Atopic Dermatitis) index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation. The variations from baseline in the Local SCORAD Index are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Time frame: up to 30 days
Change from baseline in local SCORAD Index at 3 days
The variations from baseline at 3 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.
Time frame: 3 days
Change from baseline in local SCORAD Index at 7 days
The variations from baseline at 7 days in the Local SCORAD (SCORing Atopic Dermatitis) Index are compared between lesions treated with the combination therapy and those treated with dermocorticoid alone. The local SCORAD Index includes the intensity part of SCORAD index which consists of six signs-erythema, edema/papulation, oozing/crusting, excoriation, lichenification, and xerosis-each rated from 0 (absent) to 3 (severe). The total score is the sum of the 6 items and ranges from 0 to 18, with higher scores indicating more severe local inflammation.
Time frame: 7 days
Change from baseline in pruritus severity at 3 days
Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch. The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Time frame: 3 days
Change from baseline in pruritus severity at 7 days
Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch. The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Time frame: 7 days
Change from baseline in pruritus severity at end of treatment
Severity is assessed using a visual analog scale (0-10 VAS), where 0 means no itch and 10 the worst imaginable itch. The variations from baseline in 0-10 VAS values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Time frame: up to 30 days
Time to complete lesion resolution
Complete resolution is subjectively assessed by the investigator. The time to complete resolution is compared between the two lesion treatments using Kaplan-Meier survival analysis, with differences assessed by the log-rank test.
Time frame: 30 days
Dermocorticoid use during the treatment period
The average number of applications of desonide 0.1% and Betamethasone 0.05% will be compared between lesions treated with combination therapy and those treated with dermocorticoid alone.
Time frame: 30 days
Relapse rate after initial treatment
Proportions of lesions that relapse after having achieved resolution during the treatment period are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone.
Time frame: 28 days
Time to the first relapse after initial treatment
The time to the first relapse after initial treatment is compared between the two lesion treatments using Kaplan-Meier survival analysis, with differences assessed by the log-rank test
Time frame: 28 days
Dermocorticoid use in relapsed lesions
The average number of applications of desonide 0.1% and Betamethasone 0.05% will be compared between relapsed lesions initially treated with the combination therapy and those initially treated with dermocorticoid alone.
Time frame: 28 days
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