Patients affected by seborrheic dermatitis. MedDRA version: 21.1 Level: PT Classification code 10039793 Term: Seborrhoeic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Miclast 1% crema
Product Name: Ciclopirox olamina 1% crema
Product Code: [025218013]
Pharmaceutical Form: Cream
Current Sponsor code: Ciclopirox olamina 1%
Concentration unit: % percent
Co
Sponsors
IDI FARMACEUTICI SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female, = 18 years; 2. Established diagnosis of seborrheic dermatitis of the face and scalp; 3. Able to co-operate and understand written and oral information; 4. Written informed consent. 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 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: 1. Concomitant dermatological diseases (eg acne, rosacea, contact dermatitis) 2. Recent use of treatments for seborrheic dermatitis (2 weeks for topical treatments; 4 weeks for systemic treatments); 3. Hypersensitivity to the active substance or to any of the excipients; 4. Established diagnosis of Actinic keratosis; 5. Established diagnosis of Parkinson; 6. Established diagnosis of HIV infection; 7. Use of immunesuppressant medications since last three months; 8. Established diagnosis of cardiac diseases; 9. Established diagnosis of alcoholic pancreatitis; 10. Established diagnosis of other neurological diseases; 11. Established diagnosis of Diabetic; 12. Pregnancy (positive pregnancy test for women of childbearing potential) and lactation; 13. Participation in any other clinical Study within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the non-inferiority evaluation of the efficacy of Nicotinamide DS cream compared to 1% cream Ciclopirox olamine in reducing lesions in patients affected by seborrheic dermatitis estimated with the percentage of patients with lowering of the SASI index.;Secondary Objective: 1. Amount of variation in SASI index. 2. Quality of life evaluation (Dermatology Life Quality Index - DLQI). 3. Evaluation of Malassezia colonization. 4. Evaluation of Staphylococcus epidermidis. 5. Itch evaluation Static(VAS scale). 6. Itch evaluation dynamic (Dynamic Pruritus Score). 7. S/AE or S/ADE. 8. Evaluation of dermoscopic pattern using super high magnification dermoscopy(400X);Primary end point(s): Percentage of subject with better SASI index.;Timepoint(s) of evaluation of this end point: Visit V1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Amount of variation in SASI index. 2. Dermatology Life Quality Index (DLQI). 3. Evaluation of Malassezia colonization. 4. Evaluation of Staphylococcus epidermidis. 5. VAS scale. 6. Dynamic Pruritus Score. 7. S/AEs and S/ADEs. 8. Evaluation of dermoscopic pattern using super high magnification dermoscopy (400X);Timepoint(s) of evaluation of this end point: The efficacy end points will be evaluated during Visit V1. Maintenance and safety end points will be measured during the Visit V2. | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Link Neuroscience and Health Care srl - L.N.Age srl
Outcome results
None listed