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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

6 years - 12 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Dolores Lopez Romero

Study start

2026-11 Estimated

Primary completion

2027-06 Estimated

Study completion

2027-06 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts