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

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis; Atopic Dermatitis and Related Conditions; Atopic Dermatitis \(AD\); Atopic Dermatitis Eczema

Treatments: Other: Blue Cap Foam

Study type: Interventional

Funder types: Industry

Identifiers

NCT06361992

BC_SERBIA_2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Blue cap Foam

Experimental group

Description:

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.

Treatment:

Other: Blue Cap Foam