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

The risk of an elevated intraocular pressure after treatment with topical corticosteroids in the periocular region

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000252-35-DK

Enrollment

Registered

2020-02-11

Start date

2020-07-09

Completion date

Unknown

Last updated

2023-10-30

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

Conditions

Intraocular pressure in healthy individuals and in patients with atopic dermatitis MedDRA version: 21.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858 MedDRA version: 20.1 Level: LLT Classification code 10022801 Term: Intraocular pressure System Organ Class: 100000004848

Interventions

Trade Name: Locoid Lipid 0.1 % cream Pharmaceutical Form: Cream INN or Proposed INN: HYDROCORTISONE BUTYRATE CAS Number: 13609-67-1 Concentration unit: % (W/W) percent weight/weight Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 18-75 years BMI: =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate whether daily treatment with topical corticosteroids in the periocular region causes a change in comparison to the control group. ;Secondary Objective: Duration of treatment (number of days) with topical corticosteroids prior to a measurable increase in intraocular pressure and a potential dose-dependent variation thereof.;Primary end point(s): Total change in intraocular pressure measured with 'Icare ic100 tonometer' at two, three and four weeks following introduction of the topical corticosteroids treatment.;Timepoint(s) of evaluation of this end point: 14, 21 and 28 days	—

Measure

Time frame

Main Objective: The main objective is to evaluate whether daily treatment with topical corticosteroids in the periocular region causes a change in comparison to the control group. ;Secondary Objective: Duration of treatment (number of days) with topical corticosteroids prior to a measurable increase in intraocular pressure and a potential dose-dependent variation thereof.;Primary end point(s): Total change in intraocular pressure measured with 'Icare ic100 tonometer' at two, three and four weeks following introduction of the topical corticosteroids treatment.;Timepoint(s) of evaluation of this end point: 14, 21 and 28 days

—

Secondary

Measure	Time frame
Secondary end point(s): Duration of treatment (number of days) with topical corticosteroids prior to a measurable increase in intraocular pressure and a potential dose-dependent variation thereof.;Timepoint(s) of evaluation of this end point: 14, 21 and 28 days	—

Countries

Denmark

Contacts

Public ContactDepartment of Dermatology

Gentofte Hospital

diva.amiri@regionh.dk

Outcome results

None listed

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