About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subject.

Aged 18 or more.

With mild to moderate atopic dermatitis based on the Investigator's Global Assessment for Atopic Dermatitis (IGA-AD).

Presence of two comparable atopic dermatitis lesions requiring treatment with topical corticosteroids, located at anatomically distant sites.

Disqualifiers

Subject currently participating in another clinical study that may interfere with the assessments of the present study, according to the investigator's judgment.

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.

Subject who, in the investigator's judgment, is unlikely to comply with study-related constraints and requirements.

Subject who has forfeited his/her freedom by administrative or legal decision, or who is under legal guardianship.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: URGO FilmoCream Eczema plus dermocorticoidExperimental treatment 2 interventions

Group B: Dermocorticoid aloneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

2

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

3

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

Secondary outcomes

1

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

2

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

3

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

4

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

Other outcomes

1

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.

Time frame

3 days

2

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.

Time frame

7 days

3

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.

Time frame

up to 30 days

4

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.

Time frame

3 days

URGO FilmoCream Eczema + Dermocorticoids in Atopic Dermatitis

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts