CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Blue Cap Foamother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06361992
NCT06361992Phase 3Completed

Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children

Catalysis SL·interventional·Posted Apr 12, 2024·Updated Apr 15, 2024

In Brief

A Phase 3 clinical trial evaluating Blue Cap Foam for Atopic Dermatitis and 3 related conditions. Completed, enrolled 58 participants across 3 sites.

Detailed Summary

To verify the efficacy and tolerability of Activated Piroctone Olamine (Blue Cap Foam, label volume 100 ml) by CATALYSIS, S. L. Madrid, applied in the management of all types of dermatitis (atopic, seborrheic, eczema) in patients with significant manifestations of the disease in varying areas of the body of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients aged 3 to 18 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSerbia
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedApr 12, 2024
Enrollment StartMar 15, 2022
Primary CompletionSep 15, 2023
Study CompletionFeb 13, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 2.2 years ago

Interventions

Blue Cap Foamother

Application regimen: Blue Cap foam 100 ml, Activated Piroctone Olamine (Foam, label 100 ml), Catalysis S.L. Madrid must be applied twice a day on all affected areas. The application is to be continued for 30 days, after which the patients stop using the foam until the final assessment at day 45.