Atopic Dermatitis (AD)
Conditions
Keywords
atopic dermatitis, hyaluronic acid, sh-oligopeptide-1
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDermcontrol, cream based on hyaluronic acid and sh-oligopeptide-1
Emulgel containing hyaluronic acid, glycerol, grape seed oil, Calendula officinalis, aloe vera and sh-oligopeptide-1
Sponsors
Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The person in charge of the evaluation of the participants will not know the group to which each participant was assigned.
Intervention model description
Randomised controlled clinical trial, with an intervention group, to which the repair cream will be applied in addition to receiving the conventional treatment (topical/systemic corticosteroids/monoclonal antibody/antibiotic) and a control group that will receive their conventional treatment and will not apply any other moisturising/repair cream.
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin temperature measured by ST 500 Skin thermometer | 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 | 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 | 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 | 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 | 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 | Baseline (visit 0) and day 10 (visit 1) | It reflects the condition of dermal elastic fibres. |
| Change in SCORAD | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dermatology Life Quality Index (DLQI) | Baseline (visit 0) and day 10 (visit 1) | It evaluates the impact of AD symptoms and treatments on patients' quality of life. Consisting of 10 questions with four response options (not at all, a little, a lot, very much), it is scored from 0 to 3; the response 'not relevant' is scored as 0. The final score is obtained by summing all items (range 0-30), with higher values reflecting greater impairment in quality of life. For interpretation purposes, the total score can also be expressed as a percentage of the maximum possible score (30 points). |
| User perception assessment | Day 10 (visit 1) | 10-item questionnaire covering different aspects of the formulation, including colour, odour, texture, potential irritation, absorption speed, ease of application, overall satisfaction, ease of use, packaging, and perceived improvement of the skin. Each item was rated on a seven-point scale ranging from very unsatisfactory to excellent. The mean score for each question was calculated and expressed as a percentage. |
Countries
Spain
Outcome results
None listed