Examination of the efficacy of glycerol, two topical steroids and a topical immune modulator in experimentally induced skin irritation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001678-34-DK

Enrollment

Registered

2008-07-28

Start date

2008-08-20

Completion date

Unknown

Last updated

2021-08-10

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

Conditions

Irritative contact dermatitis. MedDRA version: 9.1 Level: LLT Classification code 10010792 Term: Contact dermatitis and other eczema due to detergents

Interventions

Product Name: glycerol Pharmaceutical Form: Ointment INN or Proposed INN: GLYCEROL CAS Number: 56815 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy volunteers aged 18-45 years. 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Vounteers are excluded in case of: pregnancy, nursery, active skin disesase on test areas (forearm skin) including skin infection, immune disease or endocrine disorders, in systemical immunosupressant therapy, other topical treatment on test areas.

Design outcomes

Primary

Measure	Time frame
Main Objective: to test the efficacy of glycerol ointment compared with two different topical steroids and their vehicles.;Secondary Objective: ;Primary end point(s): any differences between treatments assessed by visual reading and non-invasive instrumental measurements during 10 days treatment. End of treatment values and summary measures (area under curve) are used for parametric and non-parametric evaluation	—

Measure

Time frame

Main Objective: to test the efficacy of glycerol ointment compared with two different topical steroids and their vehicles.;Secondary Objective: ;Primary end point(s): any differences between treatments assessed by visual reading and non-invasive instrumental measurements during 10 days treatment. End of treatment values and summary measures (area under curve) are used for parametric and non-parametric evaluation

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Countries

Denmark

Outcome results

None listed

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