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

NCT00655512 | Completed Phase 1

• 1 other identifier: TUD-OCT011-023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• thickness of epidermis

  9 times in 4 weeks

Secondary Outcomes (4)

• atrophogenic effect assessed by dermaphot

  9 times in 4 weeks

• moisture of skin assessed by corneometer

  9 times in 4 weeks

• transpire of skin assessed by tewameter

  9 times in 4 weeks

• thickness of dermis

  9 times in 4 weeks

Study Arms (5)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

3

ACTIVE COMPARATOR

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

4

ACTIVE COMPARATOR

Drug: pimecrolimus 1% cream; Drug: hydrocortisonacetat 1% cream; Drug: betamethasonvalerat 0,1% cream

5

PLACEBO COMPARATOR

Drug: Placebo

Interventions

pimecrolimus 1% cream DRUG

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

Also known as: Elidel 1% cream

2; 3; 4

hydrocortisonacetat 1% cream DRUG

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

Also known as: Hydrogalen cream

1; 3; 4

betamethasonvalerat 0,1% cream DRUG

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

Also known as: Betagalen cream

1; 2; 4

clobetasol-17-propionat 0,05% cream DRUG

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

Also known as: Clobegalen cream

1; 2; 3

Placebo DRUG

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

5

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Department of Dermatology, Medical Faculty, TU Dresden

Dresden, Germany

Location

MeSH Terms

Interventions

pimecrolimus

Study Officials

• Roland Aschoff, MD

  Department of Dermatology, Medical Faculty, Technical University Dresden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

DE (1)