Evaluating Ceramol Beta Complex® Cream to Relieve Itching After Skin Allergy Tests in Children Aged 6-12 Years (CALM-PRICK) (CALM-PRICK)
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
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Maria Dolores MD López Romero, Enfermera Especialista Pediátr
- Telefonnummer: 607580014
- E-post: mlromero@salud.madrid.org
Studiesteder
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Madrid
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Madrid, Madrid, Spania, 28007
- Hospital General Universitario Gregorio Marañón
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Ta kontakt med:
- Dolores Lopez, Nurse
- Telefonnummer: +34915290096
- E-post: mlromero@salud.madrid.org
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Sham-komparator: control group
Emollient cream application |
Apply a small amount of emollient cream after skin prick testing. |
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Aktiv komparator: Emollient Cream( SOC)
Emollient Cream( SOC) |
Application of antipruritic cream after skin prick test readings. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Effect of Ceramol Beta Complex® on Pruritus in Pediatric Patient
Tidsramme: Reduction in Itching from Cream Application to 30 Minutes Post-Application
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pruritus Intensity: Ceramol Beta Complex® vs. Emollient at T0 and T5
Tidsramme: at T0 (before cream application) and T5 (5 minutes after application).
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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).
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Pruritus Reduction: Ceramol Versus Standard Moisturizer
Tidsramme: 30 Minutes Post-Application
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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
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Reich A, Riepe C, Anastasiadou Z, Medrek K, Augustin M, Szepietowski JC, Stander S. Itch Assessment with Visual Analogue Scale and Numerical Rating Scale: Determination of Minimal Clinically Important Difference in Chronic Itch. Acta Derm Venereol. 2016 Nov 2;96(7):978-980. doi: 10.2340/00015555-2433. No abstract available.
- Haydek CG, Love E, Mollanazar NK, Valdes Rodriguez R, Lee H, Yosipovitch G, Tharp MD, Hanifin JM, Chen KH, Chen SC. Validation and Banding of the ItchyQuant: A Self-Report Itch Severity Scale. J Invest Dermatol. 2017 Jan;137(1):57-61. doi: 10.1016/j.jid.2016.06.633. Epub 2016 Aug 10.
- Stewart S, Boscher J, Hossain J, McGeady SJ, Yousef E. Pruritus from allergy skin tests in children: Comparing remedies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):429-430. doi: 10.1016/j.anai.2016.07.019. Epub 2016 Aug 10. No abstract available.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ALE-CR-1
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
It's not necessary
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