Pityriasis versicolor / Tinea versicolor MedDRA version: 8.1 Level: LLT Classification code 10056227 Term: Pityriasis versicolour
Conditions
Interventions
Product Name: Pramiconazole
Product Code: R126638
Pharmaceutical Form: Oral solution
INN or Proposed INN: Pramiconazole
CAS Number: 201410-66-4
Current Sponsor code: R126638
Concentration unit: mg/ml
Sponsors
Barrier Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has completed an appropriately administered informed consent/assent 2. Subject is at least 18 years of age and of either sex. 3. The subject has a clinical diagnosis of pityriasis (tinea) versicolor with at least mild desquamation present, and confirmation of Malassezia spp. by KOH microscopy. 4. The subject has multiple lesions in at least two of the following anatomic areas: face, neck, arms, chest, abdomen, back, and legs; or, in the investigator’s opinion, at least moderately extensive skin involvement defined as > 15% BSA. 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: 1. Subject has a history of sensitivity to any of the ingredients in the study medication 2. Subject is currently participating in, or has within the 30 days prior to the clinical trial participated in an investigational clinical trial. 3. Subject has used systemic or topical steroids, or topical antifungal therapy, including shampoos with active ingredients against Malassezia spp. or tar shampoos within the previous 30 days. 4. Subject has used systemic antifungal therapy within the previous 60 days. 5. Subject has received medications within the previous 14 days that are known to prolong the QT interval, that are contraindicated during azole treatment, that are known to influence the bioavailability of azoles, or that reduce gastric acidity which interferes with the absorption of some azoles. 6. The subject has an ECG prior to dosing with a QTcB or QTcF interval >450 milliseconds (if male) or >470 milliseconds (if female) as determined by the central ECG lab, or abnormal morphology of the ECG, or clinically serious arrhythmia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy and tolerability of five doses of R126638, in comparison to placebo, in the treatment of pityriasis versicolor.;Secondary Objective: Complete Cure at Day 28 (Erythema, desquamation and pruritus scores are 0 (none) and KOH microscopy is negative) Mycological response on Days 14 and 28 Investigator’s Global Assessment on Days 14 and 28 Individual Signs and Symptoms on Days 14 and 28;Primary end point(s): The primary endpoint is Effective Treatment at Day 28. Effective Treatment is defined as: • Erythema, desquamation and pruritus scores are 0 (none) OR • Erythema, desquamation and pruritus scores are < 1 (Minimal) if the corresponding score at baseline was 3 or 4 AND • Mycological Cure (negative KOH microscopy). | — |
Countries
Sweden
Outcome results
None listed