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

April 12, 2024 updated by: Catalysis SL
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The first reports on the possibility of using Activated Piroctone Olamine as an effective treatment for patients with papulosquamous dermatoses, eczema and seborrhoeic dermatitis date back to the 1970s. The observations are presented in scientific papers by dermatologists, pharmacologists and laboratory workers who have verified the original thesis in practice by the practical use of different types of products. Activated Piroctone Olamine as an active ingredient is now used by a number of companies in their product range, either as the only active ingredient or, for example, in combination with other active ingredients such as liquid carbonis detergens. The Spanish company CATALYSIS S.L Madrid has also started to produce preparations containing Activated Piroctone Olamine intended for targeted use in dermatological practice. The products have been named Blue Cap® and the original shampoo has been gradually supplemented by spray, cream and foam formulations. The company has an eminent interest in the serious evaluation of the products and has therefore ordered a number of large clinical multicentre studies carried out in different geographical zones - ranging from the Tropical, through the Temperate to the Siberian regions.

The active ingredient Activated Piroctone Olamine alone or in combination with other active ingredients makes for products with excellent properties. Activated Piroctone Olamine itself has a proven antiseptic, antimicrobial, antifungal and keratolytic effect.

The effect is selective, only acting on the morbidly altered cells. The concentrations of Activated Piroctone Olamine used in BLUE-CAP formulations are absolutely safe. The products can also be used on the surface of larger body areas and in virtually all age groups.

Activated Piroctone Olamine has a number of positive effects on pathological processes in the skin - high antimicrobial and antifungal effect, selective cytostatic effect on skin cells (at the stage of hyperproliferation, but does not affect healthy cells), it regulates the amount and number of cellular enzymes and determines the anti-inflammatory effect (if it is employed in a targeted manner in form of topically applied preparations.

To evaluate the efficacy and safety of the use of Piroctone Olamine in paediatric patients, the following clinical trial was conducted. A commercial formulation of Piroctone Olamine, Blue Cap, in foam format was used on patients aged 3 to 18 years and evaluated for safety and efficacy in the control of symptoms associated with dermatitis.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • City Institute for Skin and Venereal Diseases Belgrade
      • Belgrade, Serbia, 11000
        • University of Belgrade Faculty of Medicine, University Clinical Center of Serbia
    • Nišava
      • Niš, Nišava, Serbia, 18108
        • University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blue cap Foam
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.
Other: Blue Cap Foam
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Improvement of Patients with Dermatitis
Time Frame: 45 days
Assessment of the clinical improvement of paediatric patients with dermatitis over the course of the visits using a questionnaire. The global questionnaire assesses the disappearance of clinical manifestations and improvement in skin quality with the following scale: None, Slight, Moderate, Great. The evaluation of each patient is carried out at time 0, 15 days, 30 days, 45 days or on exclusion of the patient.
45 days
Clinical assessment of symptoms and sings associated with Dermatitis
Time Frame: 45 days
Evaluation of the clinical improvement of symptoms and signs associated with dermatitis in paediatric patients by means of a questionnaire on the presence or absence (Yes/No) of the following symptoms: Erythema, Scaling, Infiltration, Excoriations, Lichenification, Xerosis, Pruritus. The evaluation of each patient is carried out at time 0, 15 days, 30 days, 45 days or on exclusion of the patient.
45 days
Grade of Patient Tolerability to the investigation product
Time Frame: 45 days
Assessment of tolerance to the application of the test product in paediatric patients. This was done by following and monitoring patients in contact with the Blue Cap product at the topical level by reporting adverse effects during and after use of the product. The assessment of the tolerance of each patient is made throughout the follow-up of the patient (45 days or in case of exclusion of the patient) made by both the investigator and the patient: 1-4 (1- excellent, 2 - very good, 3 - good, 4 - intolerance).
45 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis.
Time Frame: 45 days

Evaluation of the effect of the therapy performed by the investigator according to the percentage of healing of the dermatitis affected area after the use of Blue Cap compared to baseline time: Scale of grade l-4.

  1. Excellent, 80 - 100% improvement in skin quality, excellent aesthetic effect.
  2. Satisfactory, up to 60% improvement in skin quality, satisfactory aesthetic and cosmetic effect.
  3. Insignificant improvement, 30% improvement in skin quality, dissatisfactory aesthetic and cosmetic effect
  4. Unsatisfactory condition, finding in original extent.
45 days
Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients
Time Frame: 45 days

Subjective evaluation of the effect of the therapy on skin healing by the investigator visually based on the healing of the dermatitis affected area after use of Blue Cap compared to baseline time: Scale of grade l - 4.

  1. Excellent aesthetic and cosmetic effect, no undesired effects
  2. Satisfactory aesthetic effect
  3. Insignificant improvement, unsatisfactory effect
  4. Unsatisfactory effect
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

September 15, 2023

Study Completion (Actual)

February 13, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC_SERBIA_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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