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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

Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00655512
Acronym
OCT
Enrollment
40
Registered
2008-04-10
Start date
2008-01-31
Completion date
2008-10-31
Last updated
2014-06-11

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

Conditions

Healthy

Keywords

pimecrolimus, hydrocortison, betamethasone, clobetasol-17-Propionat, Optical Coherence Tomography, skin healthy probands

Brief summary

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

Interventions

DRUGpimecrolimus 1% cream

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

DRUGhydrocortisonacetat 1% cream

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

DRUGbetamethasonvalerat 0,1% cream

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

DRUGclobetasol-17-propionat 0,05% cream

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

DRUGPlacebo

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Sponsors

Technische Universität Dresden
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
thickness of epidermis9 times in 4 weeks

Secondary

MeasureTime frame
transpire of skin assessed by tewameter9 times in 4 weeks
thickness of dermis9 times in 4 weeks
atrophogenic effect assessed by dermaphot9 times in 4 weeks
moisture of skin assessed by corneometer9 times in 4 weeks

Countries

Germany

Outcome results

None listed

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