None listed
Conditions
Interventions
Trade Name: Elidel® 1 % Creme
Product Name: Elidel 1% Creme
Product Code: D11AX15
Pharmaceutical Form: Cream
INN or Proposed INN: Elidel
Concentration unit: mg/g milligram(s)/gram
Concentration type:
Sponsors
Technical university Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age 18-40 years - health volunteers - normal dermis - written accordance of the test person 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pregnant or nursing woman, - missing contraception, - external or systemic therapy in the last 6 months with special drugs (Retinoids, Glucocorticoisteroids, Calcineurininhibitors,..) - disease of the epidermis (atopic dermatitis, psoriasis, erythrodermie,...), skin disease who makes topical application of cremes impossible - intensive UV-exposition or UV-therapy within the last 4 weeks or in trial, - simultaneous participance in other clinical studies and participation in a second trial within the last 30 days -hypersensitivity against Elidel®, Hydrogalen® Creme, Betagalen® Creme, Advantan® Creme, or Dermatop® Basecreme, - disease with anticipate a therapy with Elidel®, Betagalen® Creme, Ecural® Fettcreme, Hydrogalen® Creme, Advantan® Creme or Dermatop® Basecreme, - use of immunsuppressive drugs, or severe systemic disease, - non-compliance, -vaccination within the last 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Measurement of epidermal and dermal thickness under therapy with Pimecrolimus 1 % Creme (Elidel® 1 % Creme), Hydrocortisonacetat 1 % Creme (Hydrogalen® Creme), Betamethasonvalerat 0,1 % Creme (Betagalen® Creme), Methylprednisolonaceponat 0,1 % Creme (Advantan® Creme), Dermatop® Basecreme and without therapy by optical coherencetomography (OCT) and 20-MHZ-ultrasound.;Main Objective: If there is no dermal and epidermal thinning under therapy with the active components twice weekly for 12 weeks, this OCT-proactive trial is a safety-contribution for the actual therapy-plan of patiens with atopic dermatitis.;Secondary Objective: -measurement of cutaneous thickness by usind 20-MHZ-ultrasound, - measurement of cutaneous atrophy and teleangiectasies by using dermaphot® - measurement of cutaneous water content by usind corneometer - measurement of epidermal water loss from the cutaneous tissue by using Tewameter;Timepoint(s) of evaluation of this end point: The study lasts 9 months. first patient, first visit: november 2011, last patient, last visit: july 2012. Duration per volunteer: 12 weeks exculsive 4 weeks observationtime. 12 weeks of treatement and 4 weeks observation without treatement | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -measurement of cutaneous thickness by using 20-MHZ-ultrasound, - measurement of cutaneous atrophy and teleangieectasies by using dermaphot® - measurement of cutaneous humidity by usind corneometer - measurement of epidermal water content of the cutaneous tissue by using Tewameter;Timepoint(s) of evaluation of this end point: Primary Endpoint: EOS Secondary Endpoint: EOS | — |
Countries
Germany
Contacts
Public ContactDr. R. Aschoff
Technical University Dresden
Outcome results
None listed