Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation

Comparison of Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Experimentally Induced Skin Irritation

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00779792

Acronym

WA+TR_1

Enrollment

Registered

2008-10-24

Start date

2008-09-30

Completion date

2008-11-30

Last updated

2008-10-24

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

Conditions

Dermatitis, Contact, Dermatitis, Occupational

Keywords

Irritant contact dermatitis, experimental contact dermatitis, treatment, efficacy, topical steroids, topical immune modulators, glycerol

Brief summary

The purpose of this study is to compare the efficacy of glycerol ointment, triamcinolone acetonide ointment, clobetasol ointment and tacrolimus ointment on irritated skin in a cumulative skin irritation test model using healthy volunteers.

Detailed description

Irritant contact dermatitis (ICD) is a frequent cause of hand eczema and occupational skin disease. One way to study ICD is to expose healthy volunteer skin to chemicals and evaluate the skin response. Because different chemicals act differently on the skin, the use of different skin irritants may provide more information than relying on one irritant only. In this study the two commonly used irritants sodium lauryl sulphate and nonanoic acid are exposed to the skin in a cumulative wash test. Treatment of ICD has classically involved topical steroids and/or emollients. However, the outcome is variable with some patients being very refractory to this regimen. This study was designed to investigate the relative efficacy of the steroids triamcinolone acetonide and clobetasol, the topical immune modulator tacrolimus, a 20% Glycerol ointment compared with an inert ointment vehicle on experimentally induced irritated skin.

Interventions

DRUGclobetasol

0.5 mg Clobetasol propionate (0.5 mg/g) ointment applied twice daily for 10 consecutive days

DRUGtriamcinolone acetonide

0.5 mg ointment twice daily for 10 consecutive days

DRUGtacrolimus

0.5 mg tacrolimus ointment(0.1%) twice daily for 10 consecutive days

DRUGglycerol

0.5 mg glycerol ointment (20%) twice daily for 10 consecutive days

DRUGvehicle ointment (paraffin oil/soft white paraffin)

0.5 mg vehicle ointment twice daily for 10 consecutive days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* caucasian * normal skin on both volar forearms * oral and written informed consent

Exclusion criteria

* pregnant, lactating women * no safe anticonceptive method used * intake of systemic immunosuppressants (e.g. prednisolone) * endocrine, immune, or liver disorders * known allergy towards drugs applied to the skin

Design outcomes

Primary

Measure	Time frame
level of skin irritation as determined by visual reading, skin redness (color measurement), skin barrier integrity (transepidermal water loss measurement) and skin hydration (capacitance measurement)	End of treatment and summary measure (Area under the curve) of consecutive measurements at visit every other day for 10 days

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026