To investigate and establish a new simple method Dermatophot® score for the evaluation of skin atrophy (damage) after the usage of moderate-potent or super-potent topical steroids. MedDRA version: 9.1 Level: LLT Classification code 10040799 Term: Skin atrophy
Conditions
Interventions
Trade Name: Elidel 1%
Product Name: Pimecrolimus
Pharmaceutical Form: Cream
Trade Name: Ecural cream
Product Name: Mometasonfuroat
Pharmaceutical Form: Cream
Trade Name: Dermoxin Cream
Product Name:
Sponsors
J.W. Goethe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria •Healthy volunteers male/female age 18-60 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria •Clinical conditions that according to investigator can interfere with the Dermatophot evaluation (e.g., generalized erythroderma such as the genetic condition Netherton’s syndrome, other skin conditions such as atopic dermatitis, psoriasis) •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases •Systemic immunosuppression •Clinical signs of infection in the treatment area (e.g. viral, bacterial, fungal or specific skin disorders) •History of hypersensitivity to investigated substances to drugs with similar chemical structures and/or to any other ingredients of the formulation •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test. Females of childbearing potential and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of treatment. ‘Medically approved’ contraception may include implants, injectables, combined oral contraceptives, IUDs, but also abstinence at the discretion of the investigator •Use of other investigational drugs within 30 days of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective(s) To demonstrate that the Dermatophot® score is able to differentiate the extent of skin atrophy (damage) after 3 weeks of topical steroid application with different atrophogenity and non-atrophogenic topical formulations. ;Secondary Objective: Secondary objectives •To investigate the correlation of Dermatophot score with ultrasound measurement of epidermal thickness, •To investigate the correlation of Dermatophot score with optical coherence tomography at selected centers, •To investigate the correlation of Dermatophot score with the nanostructure of native skin using tape stripping and atomic force microscopy ( at selected centers) •To investigate the non-atrophogenic effect of pimecrolimus 1% crème •To investigate the different atrophy potential within different potency topical steroids ;Primary end point(s): To demonstrate that the Dermatophot® score is able to differentiate the extent of skin atrophy (damage) after 3 weeks of topical steroid application with different atrophogenity and non-atrophogenic topical formulations. | — |
Countries
Germany
Outcome results
None listed