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| Name | Class |
|---|---|
| Eurofins Dermscan Pharmascan | INDUSTRY |
| URGO Recherche, Innovation et Développement | UNKNOWN |
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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:
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):
This part lasts until the skin is fully healed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| URGO FilmoCream Eczema plus dermocorticoid | Experimental | During the treatment period, URGO FilmoCream Eczema is used alone in the morning and in combination with a topical corticosteroid in the evening. During the follow-up phase, it is applied only in case of relapse, twice daily. If the lesion does not improve or worsens, it must be combined with a dermocorticoid in the evening, as during the treatment period. |
|
| Dermocorticoid alone | Active Comparator | During the treatment period, a dermocorticoid is used. During the follow-up phase, dermocorticoid is applied only in case of relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment period with dermocorticoid alone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin hydration at 3 days | Skin hydration is assessed using the Corneometer® CM 825 (COURAGE & KHAZAKA), which measures the electrical capacitance of the skin surface. This parameter reflects the moisture level of the skin, providing an estimate of its hydration status. The results (hydration index) are expressed in arbitrary units (a.u.). The variations from baseline in hydration index values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christelle FOUCHER | Contact | +33380447049 | c.foucher@fr.urgo.com | |
| Joanna PAŁUBICKA | Contact | +48 58 732 02 99 | JPA@dermscan.pl |
| Name | Affiliation | Role |
|---|---|---|
| Ewa Karamon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Poland | Gdansk | Poland |
Patient data is not anonymized. To comply with European regulations, patients are informed that no sharing of IPD is planned in order to protect their personal data. Only aggregated data can be shared.
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In this intra-individual randomized design, each subject will have two comparable AD lesions, each randomized to receive either URGO FilmoCream Eczema + Desonide 0.1% cream or Desonide 0.1% cream alone.
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Evaluation of the lesions is carried out by a blind observer who is unaware of the treatment allocation of the lesions.
| Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid | Combination Product | 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. |
|
| Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid | Combination Product | 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. |
|
| Follow-up period after dermocorticoid treatment alone | Drug | During the 28-day follow-up period, in case of relapse, start with desonide 0.1%, escalate to betamethasone 0.05% if necessary. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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 | 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. | 28 days |
| 3 days |
| Change in skin hydration at 7 days | Skin hydration is assessed using the Corneometer® CM 825 (COURAGE & KHAZAKA), which measures the electrical capacitance of the skin surface. This parameter reflects the moisture level of the skin, providing an estimate of its hydration status. The results (hydration index) are expressed in arbitrary units (a.u.). The variations from baseline in hydration index values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone. | 7 days |
| Change in skin hydration at the end of the treatment | Skin hydration is assessed using the Corneometer® CM 825 (COURAGE & KHAZAKA), which measures the electrical capacitance of the skin surface. This parameter reflects the moisture level of the skin, providing an estimate of its hydration status. The results (hydration index) are expressed in arbitrary units (a.u.). The variations from baseline in hydration index values are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone. | up to 30 days |
| Change in skin barrier integrity at 3 days | Transepidermal Water Loss (TEWL) is measured using a Tewameter TM 300®. And expressed in grams per hour per square meter (g/h/m²). It quantifies the amount of water evaporating from the skin surface over one hour per unit area, providing an indicator of skin barrier function. The variations from baseline in TEWL values are compared between lesions treated with combination therapy and lesions treated with dermocorticoid alone. | 3 days |
| Change in skin barrier integrity at 7 days | Transepidermal Water Loss (TEWL) is measured using a Tewameter TM 300®. And expressed in grams per hour per square meter (g/h/m²). It quantifies the amount of water evaporating from the skin surface over one hour per unit area, providing an indicator of skin barrier function. The variations from baseline in TEWL values are compared between lesions treated with combination therapy and lesions treated with dermocorticoid alone. | 7 days |
| Change in skin barrier integrity at the end of the treatment | Transepidermal Water Loss (TEWL) is measured using a Tewameter TM 300®. And expressed in grams per hour per square meter (g/h/m²). It quantifies the amount of water evaporating from the skin surface over one hour per unit area, providing an indicator of skin barrier function. The variations from baseline in TEWL values are compared between lesions treated with combination therapy and lesions treated with dermocorticoid alone. | up to 30 days |
| Local tolerance to the treatments at Day 3 | Based on patient's reported clinical signs (pain, burning sensation, itching, discomfort or other symptoms) following application of the assigned treatment to the lesion, the investigator subjectively assesses tolerance using a 0-3 scale where 0= Poor tolerance at application, 1= Moderate tolerance at application, 2= Good tolerance at application, 3= Very good tolerance at application. Scores are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone. | 3 days |
| Local tolerance to the treatments at Day 7 | Based on patient's reported clinical signs (pain, burning sensation, itching, discomfort or other symptoms) following application of the assigned treatment to the lesion, the investigator subjectively assesses tolerance using a 0-3 scale where 0= Poor tolerance at application, 1= Moderate tolerance at application, 2= Good tolerance at application, 3= Very good tolerance at application. Scores are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone. | 7 days |
| Local tolerance to the treatments at the end of the treatment | Based on patient's reported clinical signs (pain, burning sensation, itching, discomfort or other symptoms) following application of the assigned treatment to the lesion, the investigator subjectively assesses tolerance using a 0-3 scale where 0= Poor tolerance at application, 1= Moderate tolerance at application, 2= Good tolerance at application, 3= Very good tolerance at application. Scores are compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone. | up to 28 days |
| Occurrence of adverse events during the study | Adverse events are described using MedDRA , whether they occur during the treatment period or during the follow-up period. Where appropriate, the frequency of treatment adverse effects is compared between lesions treated with the combination therapy and lesions treated with dermocorticoid alone. | up to 58 days |
| Private Practice | Malbork | Poland |
|
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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