- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07927634
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
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Maria Dolores MD López Romero, Enfermera Especialista Pediátr
- 전화번호: 607580014
- 이메일: mlromero@salud.madrid.org
연구 장소
-
-
Madrid
-
Madrid, Madrid, 스페인, 28007
- Hospital General Universitario Gregorio Marañón
-
연락하다:
- Dolores Lopez, Nurse
- 전화번호: +34915290096
- 이메일: mlromero@salud.madrid.org
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
가짜 비교기: control group
Emollient cream application |
Apply a small amount of emollient cream after skin prick testing. |
|
활성 비교기: Emollient Cream( SOC)
Emollient Cream( SOC) |
Application of antipruritic cream after skin prick test readings. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Effect of Ceramol Beta Complex® on Pruritus in Pediatric Patient
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pruritus Intensity: Ceramol Beta Complex® vs. Emollient at T0 and T5
기간: 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
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ALE-CR-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
It's not necessary
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .