Atopic Dermatitis (AD)NCT07742241
Efficacy Study of a Repairing Cream in Atopic Dermatitis
A study of Atopic Dermatitis (AD), run by Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis (AD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Study of a Repairing Cream Containing Hyaluronic Acid, Sh-oligopeptide-1, Polyphenols 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.
Read the 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Dermcontrol, cream based on hyaluronic acid and sh-oligopeptide-1
- Keywords
- atopic dermatitis, hyaluronic acid, sh-oligopeptide-1
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermcontrol, cream based on hyaluronic acid and sh-oligopeptide-1Device
Emulgel containing hyaluronic acid, glycerol, grape seed oil, Calendula officinalis, aloe vera and sh-oligopeptide-1
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control |
| Dermcontrol | Experimental | Dermcontrol Receives: Device: Dermcontrol, cream based on hyaluronic acid and sh-oligopeptide-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in skin temperature measured by ST 500 Skin thermometer
It reflects changes in microcirculation and tends to rise in cases of barrier dysfunction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (visit 0) and day 10 (visit 1)
Change in EASI
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).
Measured: Baseline (visit 0) and day 10 (visit 1)
Secondary outcomes (2)
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).
Measured: 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.
Measured: Day 10 (visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start9 Jan 2023
- Primary completion30 Apr 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742241
- Sponsor's protocol ID
- DA.HUVN-20
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of a Repairing Cream Containing Hyaluronic Acid, Sh-oligopeptide-1, Polyphenols in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07742241
- Acronym / sponsor ID
- DA.HUVN-20
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- atopic dermatitis, hyaluronic acid, sh-oligopeptide-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control |
| Dermcontrol | Experimental | Device: Dermcontrol, cream based on hyaluronic acid and sh-oligopeptide-1Dermcontrol |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermcontrol, cream based on hyaluronic acid and sh-oligopeptide-1Emulgel containing hyaluronic acid, glycerol, grape seed oil, Calendula officinalis, aloe vera and sh-oligopeptide-1 | Device | Dermcontrol |
Primary outcome
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.
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.
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.
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.
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.
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.
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).
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).
2 secondary outcomes
Change in Dermatology Life Quality Index (DLQI)
Time frame: Baseline (visit 0) and day 10 (visit 1)
User perception assessment
Time frame: Day 10 (visit 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Atopic Dermatitis (AD), run by Instituto de Investigacion Biotecnologica, Farmaceutica y Medicamentos Huerfanos, S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin temperature measured by ST 500 Skin thermometer (time frame: Baseline (visit 0) and day 10 (visit 1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.