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

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

No aplica

Rango de edad

6 años - 12 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

100 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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

¿Quién podría participar?

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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.

Tratamiento, grupos y participación

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Asignación

Asignación al azar

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (1)

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1 centros

Equipo y fechas

Patrocinador principal

Dolores Lopez Romero

Inicio del estudio

2026-11 Estimado

Finalización primaria

2027-06 Estimado

Finalización del estudio

2027-06 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio