Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361992
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-04-08
Brief Title:
Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children
Sponsor:
Catalysis SL
Organization:
Catalysis SL
Study Overview
Official Title:
Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SL 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None