Clinical trial NCT06361992: Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children
Official title: Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Atopic Dermatitis and Related Conditions
Atopic Dermatitis Eczema
Atopic Dermatitis \(AD\)
Keywords: Piroctone Olamine
paediatrics
Dermatology
Atopic Dermatitis
Skin
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Grade of Patient Tolerability to the investigation product
timeFrame: 45 days
measure: Clinical Improvement of Patients with Dermatitis
timeFrame: 45 days
measure: Clinical assessment of symptoms and sings associated with Dermatitis
timeFrame: 45 days
Secondary outcomes:
measure: Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis.
timeFrame: 45 days
measure: Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients
timeFrame: 45 days
Other outcomes:
Locations:
city: Niš
country: Serbia
facility: University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš
state: Nišava
city: Belgrade
country: Serbia
facility: City Institute for Skin and Venereal Diseases Belgrade
city: Belgrade
country: Serbia
facility: University of Belgrade Faculty of Medicine, University Clinical Center of Serbia
Study officials:
References:
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