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临床试验/NCT07742241
NCT07742241已完成不适用

Efficacy Study of a Repairing Cream Containing Hyaluronic Acid, Sh-oligopeptide-1, Polyphenols in Atopic Dermatitis

Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L.1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2023年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
Change in skin temperature measured by ST 500 Skin thermometer

研究概览

简要总结

The application of DermControl®, a repair cream based on hyaluronic acid, sh-oligopeptide-1 and polyphenols, in combination with topical corticosteroids, could help to improve epidermal barrier function in patients with atopic dermatitis, improving their symptoms and Quality of Life.

详细描述

This is an experimental study to evaluate the efficacy of DermControl® repair cream in patients with atopic dermatitis receiving conventional treatment. The clinical trial consists of a preliminary sub-study in healthy patients lasting one week to analyse epidermal barrier parameters, cutaneous homeostasis-and especially to detect unexpected adverse effects. The sub-study will consist of selecting a group of healthy adult patients, who will apply the product 2 to 4 times a day on one of their arms, leaving the other arm without applying any product. Measurements will be taken at baseline and after one week of treatment. The clinical trial itself is a randomised clinical trial, in which a control group of patients with atopic dermatitis will receive their indicated treatment, prescribed and assessed by the doctor, and an intervention group, which will receive the indicated treatment, prescribed and assessed by the doctor, plus the application of DermControl® Repair cream. All procedures will be performed and conducted by suitably qualified healthcare personnel with experience in the dermatological treatment of sensitive and damaged skin. Patients will be assessed by the principal investigator and those who meet the inclusion criteria will be admitted to the study. The children's guardians and patients will be given all the information about the study, the product, how to use, etc. They will be given an information and informed consent form, which will be signed by one of the parents. At each visit, the corresponding questionnaire (EVA, SCORAD, DQLI) and the photographic session will be completed and inspected by the medical staff.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The person in charge of the evaluation of the participants will not know the group to which each participant was assigned.

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients from 2 years of age diagnosed with AD by a dermatologist according to Hanifin and Rajka criteria, with a disease duration of at least six months.

排除标准

  • Presence of any clinical infection in the area designated for measurement.
  • History of cancer or immunosuppression.
  • Coexisting inflammatory skin conditions such as psoriasis or hidradenitis suppurativa.

结局指标

主要结局

Change in skin temperature measured by ST 500 Skin thermometer

时间窗: Baseline (visit 0) and day 10 (visit 1)

It reflects changes in microcirculation and tends to rise in cases of barrier dysfunction.

Change in erythema index measured by MX 18 mexameter

时间窗: Baseline (visit 0) and day 10 (visit 1)

Associated with skin exposure to irritants, allergens, or UV radiations.

Change in Transepidermal Water Loss (TEWL) measured by Tewameter TM300

时间窗: Baseline (visit 0) and day 10 (visit 1)

Indicator of water diffusion through the stratum corneum.

Change in Stratum Corneum Hydration (SCH) measured by CM 825 Corneometer

时间窗: Baseline (visit 0) and day 10 (visit 1)

Marker of epidermal water content and related to the lipid organisation in the barrier.

Change in skin pH measured by PH 905 skin pHmeter

时间窗: Baseline (visit 0) and day 10 (visit 1)

Relevant for lipid organisation and metabolism within the stratum corneum.

Change in skin elasticity measured by Cutometer dual MPA 580

时间窗: Baseline (visit 0) and day 10 (visit 1)

It reflects the condition of dermal elastic fibres.

Change in SCORAD

时间窗: Baseline (visit 0) and day 10 (visit 1)

It assesses severity, integrating affected area, intensity of clinical signs and subjective symptoms. It is classified as mild (0-25), moderate (25-50) or severe (\>50).

Change in EASI

时间窗: Baseline (visit 0) and day 10 (visit 1)

It assesses the extent and severity of eczema across four anatomical regions: the head and neck, the trunk, the upper limbs, and the lower limbs. The severity categories were defined as follows: mild (\<7), moderate (7.1-21), severe (21.1-50) and very severe (\>50).

次要结局

  • Change in Dermatology Life Quality Index (DLQI)(Baseline (visit 0) and day 10 (visit 1))
  • User perception assessment(Day 10 (visit 1))

研究者

发起方
Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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