Open-label Clinical Investigation to Evaluate the Performance and Safety of Medical Device "Urgo Filmocream Eczema" in Association With Dermocorticoids on Atopic Dermatitis Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change from baseline in local SCORAD Index at end of treatment
研究概览
简要总结
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:
- Does URGO FilmoCream Eczema improve symptom relief of atopic dermatitis when used alongside standard topical corticosteroid treatment?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Evaluation of the lesions is carried out by a blind observer who is unaware of the treatment allocation of the lesions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Having given her/his informed, written consent,
- •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.
- •Psychologically capable of understanding the study information and providing informed consent.
- •Affiliated to a health social security system.
- •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.
排除标准
- •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.
- •Female subject of childbearing potential who is pregnant, breastfeeding, or planning to become pregnant during the study.
- •Subject with a known contraindication to topical corticosteroids, such as hypersensitivity to desonide, betamethasone, or any component of the prescribed corticosteroid formulations.
- •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.
- •Subject with a skin disease, abnormality, or dermatological condition in the study area that may interfere with study assessments.
- •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.
- •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.
- •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.
研究组 & 干预措施
URGO FilmoCream Eczema plus dermocorticoid
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.
干预措施: Treatment period with combination of URGO FilmoCream Eczema and dermocorticoid (Combination Product)
URGO FilmoCream Eczema plus dermocorticoid
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.
干预措施: Follow-up period after treatment with URGO Filmocream Eczema associated with dermocorticoid (Combination Product)
Dermocorticoid alone
During the treatment period, a dermocorticoid is used. During the follow-up phase, dermocorticoid is applied only in case of relapse.
干预措施: Treatment period with dermocorticoid alone (Drug)
Dermocorticoid alone
During the treatment period, a dermocorticoid is used. During the follow-up phase, dermocorticoid is applied only in case of relapse.
干预措施: Follow-up period after dermocorticoid treatment alone (Drug)
结局指标
主要结局
Change from baseline in local SCORAD Index at end of treatment
时间窗: 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 3 days
时间窗: 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.
Change from baseline in local SCORAD Index at 7 days
时间窗: 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.
次要结局
- Time to the first relapse after initial treatment(28 days)
- Change from baseline in pruritus severity at 3 days(3 days)
- Change from baseline in pruritus severity at 7 days(7 days)
- Change from baseline in pruritus severity at end of treatment(up to 30 days)
- Time to complete lesion resolution(30 days)
- Dermocorticoid use during the treatment period(30 days)
- Relapse rate after initial treatment(28 days)
- Dermocorticoid use in relapsed lesions(28 days)