Atopic Dermatitis
Conditions
Keywords
eczema lesions, adjuvant treatment to dermocorticoids, URGO FilmoCream Eczema
Brief summary
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.
Detailed description
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.
Interventions
DRUGTreatment period with dermocorticoid alone
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.
COMBINATION_PRODUCTTreatment period with combination of URGO FilmoCream Eczema and dermocorticoid
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.
COMBINATION_PRODUCTFollow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid
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.
DRUGFollow-up period after dermocorticoid treatment alone
During the 28-day follow-up period, in case of relapse, start with desonide 0.1%, escalate to betamethasone 0.05% if necessary.
Sponsors
Eurofins Dermscan Pharmascan
URGO Recherche, Innovation et Développement
CEN Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Evaluation of the lesions is carried out by a blind observer who is unaware of the treatment allocation of the lesions.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subject. 2. Aged 18 or more. 3. With mild to moderate atopic dermatitis based on the Investigator's Global Assessment for Atopic Dermatitis (IGA-AD). 4. Presence of two comparable atopic dermatitis lesions requiring treatment with topical corticosteroids, located at anatomically distant sites. 5. Having given her/his informed, written consent, 6. Cooperative, fully informed of the treatment procedures, and aware of the importance and schedule of follow-up visits, ensuring expected full adherence to the study protocol. 7. Psychologically capable of understanding the study information and providing informed consent. 8. Affiliated to a health social security system. 9. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end and must have a negative urine pregnancy test before the first treatment.
Exclusion criteria
1. Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment. 2. Subject unable to understand the information provided - including study procedures - due to linguistic or psychiatric reasons, and therefore unable to give written informed consent or to complete the study diary as required. 3. Subject who, in the investigator's judgment, is unlikely to comply with study-related constraints and requirements. 4. Subject who has forfeited his/her freedom by administrative or legal decision, or who is under legal guardianship. 5. Female subject of childbearing potential who is pregnant, breastfeeding, or planning to become pregnant during the study. 6. Subject with a known contraindication to topical corticosteroids, such as hypersensitivity to desonide, betamethasone, or any component of the prescribed corticosteroid formulations. 7. Subject with broken or ulcerated skin, acne, rosacea (including perioral dermatitis), any untreated or active skin infection (viral, bacterial, or fungal), or skin thinning at the application sites. 8. Subject with a skin disease, abnormality, or dermatological condition in the study area that may interfere with study assessments. 9. Subject with acute, chronic, or progressive disease, or relevant medical history, considered by the investigator to be hazardous for the subject, incompatible with the study, or likely to interfere with study assessments. 10. Any systemic treatment, including oral corticosteroids, that is incompatible with the study or likely to interfere with study assessments according to the investigator, administered in the weeks prior to the inclusion visit, ongoing, or planned to start during the study. 11. Any topical treatment on the tested area that is incompatible with the study or likely to interfere with study assessments according to the investigator, administered in the weeks prior to the inclusion visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in local SCORAD Index at end of treatment | up to 30 days | 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. |
| Change from baseline in local SCORAD Index at 7 days | 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. |
| Change from baseline in local SCORAD Index at 3 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pruritus severity at 3 days | 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. |
| Change from baseline in pruritus severity at 7 days | 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. |
| Change from baseline in pruritus severity at end of treatment | up to 30 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 to complete lesion resolution | 30 days | 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. |
| Dermocorticoid use during the treatment period | 30 days | 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. |
| Relapse rate after initial treatment | 28 days | 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 to the first relapse after initial treatment | 28 days | 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 |
| Dermocorticoid use in relapsed lesions | 28 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in skin hydration at 7 days | 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. |
| Change in skin barrier integrity at 3 days | 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. |
| Change in skin hydration at the end of the treatment | up to 30 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. |
| Change in skin barrier integrity at 7 days | 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. |
| Change in skin barrier integrity at the end of the treatment | up to 30 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. |
| Local tolerance to the treatments at Day 3 | 3 days | 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. |
| Local tolerance to the treatments at Day 7 | 7 days | 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. |
| Local tolerance to the treatments at the end of the treatment | up to 28 days | 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. |
| Occurrence of adverse events during the study | up to 58 days | 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. |
| Change in skin hydration at 3 days | 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. |
Countries
Poland
Contacts
Primary ContactChristelle FOUCHER
Backup ContactJoanna PAŁUBICKA
Outcome results
None listed