CompletedNot Applicable

Efficacy Study of a Repairing Cream in Atopic Dermatitis

Spain116 participantsStarted 2023-01-09

Plain-language 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.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in skin temperature measured by ST 500 Skin thermometer

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in erythema index measured by MX 18 mexameter

Timeframe: Baseline (visit 0) and day 10 (visit 1)

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

Timeframe: Baseline (visit 0) and day 10 (visit 1)

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

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in skin pH measured by PH 905 skin pHmeter

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in skin elasticity measured by Cutometer dual MPA 580

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in SCORAD

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Trial details

NCT IDNCT07742241

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Atopic Dermatitis (AD) trials

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in skin temperature measured by ST 500 Skin thermometer

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in erythema index measured by MX 18 mexameter

Timeframe: Baseline (visit 0) and day 10 (visit 1)

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

Timeframe: Baseline (visit 0) and day 10 (visit 1)

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

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in skin pH measured by PH 905 skin pHmeter

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in skin elasticity measured by Cutometer dual MPA 580

Timeframe: Baseline (visit 0) and day 10 (visit 1)

Change in SCORAD

Timeframe: Baseline (visit 0) and day 10 (visit 1)