EUCTR2007-006272-11-DE
Active, not recruiting
Not Applicable
Validation of Dermatophot for the assessment of steroid induced skin atrophy - Validel
J.W. Goethe University Hospital0 sites36 target enrollmentApril 1, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- 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.
- Sponsor
- J.W. Goethe University Hospital
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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