Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound

Technische Universität Dresden

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: pimecrolimus 1% cream; Drug: betamethasonvalerat 0,1% cream; Drug: hydrocortisonacetat 1% cream; Drug: Placebo; Drug: clobetasol-17-propionat 0,05% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT00655512

TUD-OCT011-023

Details and patient eligibility

About

to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male and female probands age between 18-40 years
• skin healthy
• skintype I-III according to Fitzpatrick

Exclusion criteria

• women of childbearing potential without adequate contraception
• pregnant or breastfeeding
• genetic defect of epidermal barrier
• external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry
• skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot
• UV treatment within the last 4 weeks before study entry
• participation to another clinical trial within the last 30 days before study entry
• allergy against pimecrolimus or hydrocortison or betamethasonvalerat or Clobetasol-17-propionat
• severe systemic diseases; ongoing immunosuppressive treatment
• planned vaccination should realize before study entry or 28 days after end of treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 5 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: clobetasol-17-propionat 0,05% cream

Drug: hydrocortisonacetat 1% cream

Drug: betamethasonvalerat 0,1% cream

2

Active Comparator group

Treatment:

Drug: clobetasol-17-propionat 0,05% cream

Drug: betamethasonvalerat 0,1% cream

Drug: pimecrolimus 1% cream

3

Active Comparator group

Treatment:

Drug: clobetasol-17-propionat 0,05% cream

Drug: hydrocortisonacetat 1% cream

Drug: pimecrolimus 1% cream

4

Active Comparator group

Treatment:

Drug: hydrocortisonacetat 1% cream

Drug: betamethasonvalerat 0,1% cream

Drug: pimecrolimus 1% cream

5

Placebo Comparator group

Treatment:

Drug: Placebo