NCT06361992CompletedPhase 3
Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children
Source: ClinicalTrials.gov · Last updated 15 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 8 Apr 2024
- Start date
- Mar 2022
- Primary completion date
- Sept 2023
- Lead sponsor
- Catalysis SL
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06361992
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 58
- From Mar 2022 to the primary completion date, Sept 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Specific exclusion criteria
- Usage of other systemic preparation which might influence the final assessment (natural preparations, physical therapy)
- Known allergy to the tested preparation
- Disease focus infection manifestations (superinfection requiring therapy)
- Immunosuppressive therapy
- Cancer
- Malignancies
- General exclusion criteria:
- Alcohol and drug abuse.
- Participation in another clinical trial within the past 30 days.
- Simultaneous participation in any other clinical trial.
- Other reasons excluding the patient from the trial.
- Restricted ability of the patient to follow therapy instructions.
- Other physical or mental disorders disturbing the trial plan.
- Possible consent withdrawal, presumed patient unreliability.
Who the study is looking for
- Dermatitis affecting different areas of the body in varying extent.
- Outpatient status
- Age of 3 to 18 years, male, female
- Voluntary participation in the trial
- Signed informed patient consent form (Parents, legal tutor, or individual)
- One-time participation in the trial
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Belgrade Faculty of Medicine, University Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| City Institute for Skin and Venereal Diseases Belgrade Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.