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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
116
Emulgel containing hyaluronic acid, glycerol, grape seed oil, Calendula officinalis, aloe vera and sh-oligopeptide-1
Hospital Universitario Virgen de las Nieves
Granada, Spain
Change in skin temperature measured by ST 500 Skin thermometer
It reflects changes in microcirculation and tends to rise in cases of barrier dysfunction.
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in erythema index measured by MX 18 mexameter
Associated with skin exposure to irritants, allergens, or UV radiations.
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in Transepidermal Water Loss (TEWL) measured by Tewameter TM300
Indicator of water diffusion through the stratum corneum.
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in Stratum Corneum Hydration (SCH) measured by CM 825 Corneometer
Marker of epidermal water content and related to the lipid organisation in the barrier.
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in skin pH measured by PH 905 skin pHmeter
Relevant for lipid organisation and metabolism within the stratum corneum.
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in skin elasticity measured by Cutometer dual MPA 580
It reflects the condition of dermal elastic fibres.
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in SCORAD
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).
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in EASI
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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).
Time frame: Baseline (visit 0) and day 10 (visit 1)
Change in Dermatology Life Quality Index (DLQI)
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).
Time frame: Baseline (visit 0) and day 10 (visit 1)
User perception assessment
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.
Time frame: Day 10 (visit 1)