Staphylococcus super infection in atopic dermatitis MedDRA version: 9.1 Level: LLT Classification code 10042566 Term: Superinfection
Conditions
Interventions
Product Name: InfectoDermaSept Creme 2%
Product Code: InfectoDermaSept
Pharmaceutical Form: Cream
INN or Proposed INN: Triclosan
CAS Number: 003380-34-5
Current Sponsor code: Triclosan
Other descripti
Sponsors
InfectoPharm Arzneimittel und Consilium GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed ICF (informed consent form), patients aged 6 month to 50 years, first atopic dermatitis diagnosis at least 4 Week prior study entry, actual clinically manifested atopic dermatitis, disseminated symmetric eczemas of the limbs, SCORAD (SCORing Atopic Dermatitis) (ESCORAD) between 5 and 12, Staphylococcus superinfection. Are the trial subjects under 18? yes 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: Treatment with or need of oral or topical corticosteroids, non steroidal immunosuppressant agents, pimecrolimus, tacrolimus, antibiotics, immunomodulators, antihistamines; usage of soaps, lotions, creams and solutions with antiseptic ingredients e.g. potassium permanganate, chlorhexidine, povidone iodine; treatment with phototherapy or ultraviolet (UV) treatment or photochemotherapy (PUVA); peracute or erosive eczema; exsudative phases of atopic dermatitis; known hypersensitivity to triclosan or one of the ingredients of the cream; immunodeficiency; distinct impetigo, erysipelas or abscess; systemic bacterial or mycotic infections and severe viral systemic infections; severe systemic diseases; pregnancy and lactation; previous participation in a study within the last 30 days; alcohol and drug abuses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Changes in ESCORAD (SCORing Atopic Dermatitis of extremities) from baseline to day 14. ;Secondary Objective: Efficacy parameters: Changes in logarithm of staphylococcus-bacteria count from baseline to day 14. Changes in ESCORAD from baseline to day 7. Changes in single-ESCORAD of erythema, edema/papulation, oozing/crusting, excoriation, lichenification from baseline to day 7 and 14. Changes in logarithm of staphylococcus-bacteria count from baseline to day 7. Clinical and microbiological response rates for day 7 and 14. evaluation of skin parameters on a numeric scale by the investigator and the subject. Safety parameters: local frequency of side effects. Tolerance and efficacy evaluation on a numeric scale from 1-6 by the investigator and the patient. Compliance. ;Primary end point(s): Changes in ESCORAD from baseline to endpoint – calculated as difference between both ESCORADs taken from the CRF – both treatment-groups will be compared with double-sided t-test. The results are considered to be significant for a probability p < 0.05. | — |
Countries
Germany
Outcome results
None listed