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

NCT06361992 | Completed Phase 3

• 1 other identifier: BC_SERBIA_2022
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Piroctone Olamine; paediatrics; Dermatology; Atopic Dermatitis; Skin

Outcome Measures

Primary Outcomes (3)

• Grade of Patient Tolerability to the investigation product

  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

• Clinical Improvement of Patients with Dermatitis

  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

  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

Secondary Outcomes (2)

• Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis.

  45 days

• Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients

  45 days

Study Arms (1)

Blue cap Foam

EXPERIMENTAL

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

Interventions

Blue Cap Foam OTHER

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.

Blue cap Foam

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Catalysis SL: lead

Study Sites (3)

University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš

Niš, Nišava, 18108, Serbia

Location

City Institute for Skin and Venereal Diseases Belgrade

Belgrade, 11000, Serbia

Location

University of Belgrade Faculty of Medicine, University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (8)

• Leung DY. New insights into atopic dermatitis: role of skin barrier and immune dysregulation. Allergol Int. 2013 Jun;62(2):151-61. doi: 10.2332/allergolint.13-RAI-0564.

  PMID: 23712284 BACKGROUND

• Chovatiya R, Paller AS. JAK inhibitors in the treatment of atopic dermatitis. J Allergy Clin Immunol. 2021 Oct;148(4):927-940. doi: 10.1016/j.jaci.2021.08.009. Epub 2021 Aug 24.

  PMID: 34437922 BACKGROUND

• Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.

  PMID: 25482871 BACKGROUND

• Nakashima C, Yanagihara S, Otsuka A. Innovation in the treatment of atopic dermatitis: Emerging topical and oral Janus kinase inhibitors. Allergol Int. 2022 Jan;71(1):40-46. doi: 10.1016/j.alit.2021.10.004. Epub 2021 Nov 21.

  PMID: 34815171 BACKGROUND

• Puviani M, Campione E, Offidani AM, De Grandi R, Bianchi L, Bobyr I, Giannoni M, Campanati A, Bottagisio M, Bidossi A, De Vecchi E, Eisendle K, Milani M. Effects of a cream containing 5% hyaluronic acid mixed with a bacterial-wall-derived glycoprotein, glycyrretinic acid, piroctone olamine and climbazole on signs, symptoms and skin bacterial microbiota in subjects with seborrheic dermatitis of the face. Clin Cosmet Investig Dermatol. 2019 May 2;12:285-293. doi: 10.2147/CCID.S205904. eCollection 2019.

  PMID: 31190937 BACKGROUND

• Piquero-Casals J, Hexsel D, Mir-Bonafe JF, Rozas-Munoz E. Topical Non-Pharmacological Treatment for Facial Seborrheic Dermatitis. Dermatol Ther (Heidelb). 2019 Sep;9(3):469-477. doi: 10.1007/s13555-019-00319-0. Epub 2019 Aug 8.

  PMID: 31396944 BACKGROUND

• Pierard-Franchimont C, Goffin V, Henry F, Uhoda I, Braham C, Pierard GE. Nudging hair shedding by antidandruff shampoos. A comparison of 1% ketoconazole, 1% piroctone olamine and 1% zinc pyrithione formulations. Int J Cosmet Sci. 2002 Oct;24(5):249-56. doi: 10.1046/j.1467-2494.2002.00145.x.

  PMID: 18498517 BACKGROUND

• Fabbrocini G, Panariello L, DE Padova MP, Lorenzi S, Caro G, Marasca C, Russo G. Efficacy and tolerability of a spray product containing hydroxypropyl chitosan, climbazole and piroctone olamine, applied twice weekly for the treatment of the pitiriasis versicolor. G Ital Dermatol Venereol. 2017 Dec;152(6):565-568. doi: 10.23736/S0392-0488.16.05299-8. Epub 2016 Jul 5.

  PMID: 27377141 BACKGROUND

Related Links

• Results of the pilot study conducted with Blue Cap Foam in paediatric patients previously in Slovakia.
• Results of the pilot study conducted with Blue Cap Foam in paediatric patients previously in St. Petersburg.

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: March 15, 2022
• Primary Completion: September 15, 2023
• Study Completion: February 13, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

SE (3)