dandruff and seborroic dermatitis MedDRA version: 6.1 Level: PT Classification code 10050909
Conditions
Interventions
Pharmaceutical Form: Shampoo
INN or Proposed INN: Ketoconazole
Concentration unit: % percent
Concentration type: equal
Concentration number: .5-
Sponsors
MIPHARM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients between 18 and 70 years old, - Patients affected by moderate dandruff (total Scaling Severity Score at least 25, either at the begining or the end of the run-in period) and seborroic dermatitis, - Patients able to give their written informed consent, - Patients able to understand the nature, procedures and objectives of the study. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with positive history for hypersensibility to ketoconazole and any other ingredient of the study products, - Pregnant or lactating femal patients, - Patients affected by other infective or inflammatory skin diseases of the hair skin, - Patients treated, during the all study period, with topic preparations (e.g.. Minoxidil) or systemic preparations which, according to Investigator?s opinion, could influence the assessment of the clinical response to the study preparations, - Patients previously treated with antifungal drugs (either topical or systemic) in the last four weeks before study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary End point will be efficacy assessment evaluated through ?Scaling Severity Score? in multiple hair skin areas.;Secondary Objective: Secondary End points will be: - Efficacy assessment by means of dermatoscopy to assess the extent of erhythema and hair skin desquamation - Efficacy assessment through ?Score Clinico Globale? (GAS) - Safety assessment by reporting of any local reaction observed during the trial, - Agreeableness assement by means of a Questionnaire to be filled in by the patient.;Primary end point(s): Primary End point will be efficacy assessment evaluated through ?Scaling Severity Score? in multiple hair skin areas. | — |
Countries
Italy
Outcome results
None listed