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Evaluating Ceramol Beta Complex® Cream to Relieve Itching After Skin Allergy Tests in Children Aged 6-12 Years (CALM-PRICK) (CALM-PRICK)

3. november 2026 opdateret af: Dolores Lopez Romero

Efficacy of a Soothing Topical Cream (Ceramol Beta Complex®) Compared With a Control Emollient Cream in Reducing Itching After Skin Prick Tests in Pediatric Patients

Skin prick tests are among the most widely used diagnostic procedures for IgE-mediated allergic diseases, such as rhinitis, bronchial asthma, and food allergy. They are rapid, cost-effective, and sensitive techniques; however, they may cause local discomfort and itching (pruritus), which can be particularly distressing for children.

In pediatric nursing, improving patient comfort and reducing anxiety are key priorities. Various interventions, including topical corticosteroids, ice, and cold, wet compresses, have been used to relieve itching, but none has been shown to effectively reduce pruritus following skin prick testing. Available evidence suggests that post-prick test itching usually resolves spontaneously and that topical corticosteroids have not demonstrated clear superiority over simple interventions. Therefore, this study will evaluate whether applying the soothing topical cream Ceramol Beta Complex® effectively relieves itching, improves the quality of nursing care, and enhances patient well-being.Applying Ceramol Beta Complex® after skin prick test results have been read may reduce the intensity or duration of itching in children aged 6-12 years compared with a moisturizing cream without specific soothing active ingredients.To evaluate the efficacy of Ceramol Beta Complex® cream in reducing pruritus associated with positive skin prick test reactions in pediatric patients.This prospective, randomized study will include children aged 6-12 years undergoing skin prick testing in a pediatric allergy clinic. A total of 100 children will be enrolled and randomly allocated to one of two groups: (A) an intervention group, which will receive Ceramol Beta Complex® cream, or (B) a control group, which will receive the emollient cream routinely used in our pediatric allergy clinics

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Maria Dolores MD López Romero, Enfermera Especialista Pediátr
  • Telefonnummer: 607580014
  • E-mail: mlromero@salud.madrid.org

Studiesteder

  • Spanien
    • Madrid
      • Madrid, Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Marañón
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 12 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  • Boys and girls aged 6-12 years.
  • Clinical indication for allergy skin prick testing as part of routine clinical care.
  • Children undergoing skin prick testing for the first time, in order to minimize suggestion or conditioning bias resulting from previous experiences.
  • Children with a positive result (wheal size ≥ 3 × 3 mm) to at least one allergen extract.
  • Written informed consent signed by parents or legal guardians, and the child's assent when appropriate.

Exclusion Criteria

  • Active skin lesions at the site of skin prick testing (forearm).
  • Known allergy to any of the ingredients of Ceramol Beta Complex® cream.
  • Known allergy to any of the ingredients of the emollient cream routinely used in our clinic.
  • Treatment within the previous 5 days with systemic or topical antihistamines; topical corticosteroids applied to the forearm within the previous week; oral corticosteroids within the previous 4 weeks; or other products that may interfere with the results.
  • Patients who have previously undergone skin prick testing at our clinic.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: control group

Emollient cream application
Andet: The control group will receive an emollient cream (B), prepared by the hospital pharmacy, without antipruritic or soothing ingredients.

Apply a small amount of emollient cream after skin prick testing.
Aktiv komparator: Emollient Cream( SOC)

Emollient Cream( SOC)
Andet: Application of antipruritic cream

Application of antipruritic cream after skin prick test readings.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of Ceramol Beta Complex® on Pruritus in Pediatric Patient
Tidsramme: Reduction in Itching from Cream Application to 30 Minutes Post-Application

Evaluation of Pruritus Score Changes Following Ceramol Beta Complex® Treatment in Pediatric Patients with Positive Skin Prick Tests: A Controlled Study
Reduction in Itching from Cream Application to 30 Minutes Post-Application

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pruritus Intensity: Ceramol Beta Complex® vs. Emollient at T0 and T5
Tidsramme: at T0 (before cream application) and T5 (5 minutes after application).

To compare pruritus intensity following the application of Ceramol Beta Complex® versus a standard emollient cream without active soothing ingredients, routinely used in the Pediatric Allergy Clinic after skin prick testing.
at T0 (before cream application) and T5 (5 minutes after application).
Pruritus Reduction: Ceramol Versus Standard Moisturizer
Tidsramme: 30 Minutes Post-Application

To determine whether the application of Ceramol Beta Complex® produces a reduction of ≥2 points on the pruritus scale compared with the standard moisturizer routinely used
30 Minutes Post-Application

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dolores Lopez Romero

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

27. oktober 2026

Først indsendt, der opfyldte QC-kriterier

3. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALE-CR-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

It's not necessary

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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