Evaluation of Dermasectan cream versus standard of care to compare their effectiveness and safety in treating atopic dermatitis (eczema) in children

A prospective, multicenter, comparative study of Dermasectan versus standard of care (e.g. hydrocortisone) in the current clinical practice using subjective assessment in children with atopic dermatitis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11118799

Enrollment

Registered

2021-11-24

Start date

2019-08-20

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis

Interventions

Each patient was enrolled after the doctor decided to prescribe Dermasectan or SoC (e.g. hydrocortisone 10 mg / g ointment) and met the eligibility criteria in a 1:1 ratio. Dermasectan was provided by

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged between 6 months and 12 years old 2. Children with a confirmed diagnostic of atopic dermatitis 3. Patients initiated on standard of care for atopic dermatitis (e.g. hydrocortisone) or children initiated on Dermasectan at the moment of signing the informed consent 4. Informed consent signed according to local legislation

Exclusion criteria

Exclusion criteria: 1. Illness within the past 4 days before study enrollment or any medical condition that may affect the risk of study participation 2. Active diagnosis or history of other severe dermatological conditions 3. Concomitant use of medications that may affect the study; products that could have a similar effect as the investigated products (e.g. corticosteroids, anti-inflammatories) 4. Previous allergic reaction or known sensitivity to ingredients in study agents

Design outcomes

Primary

Measure	Time frame
Efficacy assessed by: 1. Erythema, pruritus, exudation, excoriation, crusted erosions and lichenification assessed using a 4-point (0-3) scale - the Atopic Dermatitis Severity Index (ADSI) - recorded at visits on day 0, day 8 and day 15 2. Redness, swelling, oozing/crusting, scratch marks, skin thickening (lichenification) and dryness measured using the SCORAD (Score Atopic Dermatitis) Calculator at the doctor’s office at the time of the visits on day 0, day 8 and day 15 3. Patient chart assessment by the Patient Oriented Eczema Measure (POEM) recorded at visits on day 0, day 8 and day 15	—

Measure

Time frame

Efficacy assessed by: 1. Erythema, pruritus, exudation, excoriation, crusted erosions and lichenification assessed using a 4-point (0-3) scale - the Atopic Dermatitis Severity Index (ADSI) - recorded at visits on day 0, day 8 and day 15 2. Redness, swelling, oozing/crusting, scratch marks, skin thickening (lichenification) and dryness measured using the SCORAD (Score Atopic Dermatitis) Calculator at the doctor’s office at the time of the visits on day 0, day 8 and day 15 3. Patient chart assessment by the Patient Oriented Eczema Measure (POEM) recorded at visits on day 0, day 8 and day 15

—

Secondary

Measure	Time frame
Safety outcomes (percentage of participants who experienced an adverse event, number of drop-outs due to side effects, disease progression) evaluated during the study visit on day 8, day 15 and day 28	—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026