The risk of an increased eye pressure after treatment with steroid cream around the eye

Phase 1

• Conditions: Intraocular pressure in healthy individuals and in patients with atopic dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; MedDRA version: 20.1Level: LLTClassification code 10022801Term: Intraocular pressureSystem Organ Class: 100000004848; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2020-000252-35-DK
• Lead Sponsor: one Skov

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-11
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Age: 18-75 years
BMI: <30 kg/m2
Signed consent

Only relevant for patients with atopic dermatitis:
Known atopic dermatitis, assessed by EASI (Eczema Area and Severity Index) and TLSS (Target Lesion Severity Score)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical history of an eye disease that requires treatment with corticosteroids, including inflammatory eye diseases, such as iritis.

Treatment with previous drugs that contains corticosteroid (within the last 4 weeks).

Allergy towards the ingredients in the drugs administered during the trial.

Diagnosed diseases that may affect or can be affected by the trial/treatment. These include untreated infections, acne vulgaris, rosacea, perioral dermatitis and malignant/premalignant lesions.

Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified