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Completed

NCT Number: NCT07742241

Efficacy Study of a Repairing Cream in Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dermcontrol, cream based on hyaluronic acid and sh-oligopeptide-1

Device

Emulgel containing hyaluronic acid, glycerol, grape seed oil, Calendula officinalis, aloe vera and sh-oligopeptide-1

Primary outcomes

  1. Change in skin temperature measured by ST 500 Skin thermometer

    Time frame: Baseline (visit 0) and day 10 (visit 1)

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

  2. Change in erythema index measured by MX 18 mexameter

    Time frame: Baseline (visit 0) and day 10 (visit 1)

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

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

    Time frame: Baseline (visit 0) and day 10 (visit 1)

    Indicator of water diffusion through the stratum corneum.

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

    Time frame: Baseline (visit 0) and day 10 (visit 1)

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

  5. Change in skin pH measured by PH 905 skin pHmeter

    Time frame: Baseline (visit 0) and day 10 (visit 1)

    Relevant for lipid organisation and metabolism within the stratum corneum.

  6. Change in skin elasticity measured by Cutometer dual MPA 580

    Time frame: Baseline (visit 0) and day 10 (visit 1)

    It reflects the condition of dermal elastic fibres.

  7. Change in SCORAD

    Time frame: 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).

  8. Change in EASI

    Time frame: 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 outcomes

  1. Change in Dermatology Life Quality Index (DLQI)

    Time frame: 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).

  2. User perception assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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