Validation of Dermatophot for the assessment of steroid induced skin atrophy - Validel

• 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.; MedDRA version: 9.1Level: LLTClassification code 10040799Term: Skin atrophy

• Registration Number: EUCTR2007-006272-11-DE
• Lead Sponsor: J.W. Goethe University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified