Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
2026년 9월 15일 업데이트: Brainfarma Industria Química e Farmacêutica S/A
Clinical, Subjective, and Instrumental Evaluation of Dermatological Acceptability and Efficacy in Improving Dryness, Hydration, and Skin Barrier Function in Participants With Xerosis
The goal of this clinical trial is to evaluate the dermatological safety and efficacy of a moisturizing product in participants with moderate to severe xerosis of the lower limbs. The main questions it aims to answer are:
- Does the investigational product demonstrate dermatological acceptability and absence of irritation under real-world conditions of use?
- Does the investigational product improve skin hydration after single and repeated applications?
- Does the investigational product improve skin barrier recovery and strengthen skin barrier function?
- How do participants perceive the performance and efficacy of the investigational product?
Participants will:
- Apply the investigational moisturizing product twice daily for 28 days.
- Undergo clinical dermatological evaluations to assess skin tolerability and potential irritation.
- Undergo instrumental assessments of skin hydration using a Corneometer® and skin barrier function using a Tewameter®.
- Complete questionnaires regarding product performance and perceived efficacy.
The study will enroll 22 male and female participants aged 35 to 65 years with clinically confirmed moderate to severe xerosis of the lower limbs.
연구 개요
연구 유형
중재적
등록 (추정된)
22
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Layane Melody Da Silva Reis Cavalcante
- 전화번호: +55 (11) 4507-2183
- 이메일: layane.reis@brainfarma.ind.br
연구 장소
-
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São Paulo
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Osasco, São Paulo, 브라질, 06023-070
- 모병
- Grupo Medcin
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연락하다:
- Camila Canale
- 전화번호: +55 (11) 98343 6952
- 이메일: camila.canale.ext@medcin.com.br
-
수석 연구원:
- Sergio Schalka
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Male and female participants aged 36 to 65 years.
- Participants presenting moderate to severe xerosis of the lower limbs, corresponding to grades 2 or 3 on the Overall Dry Skin Score (ODS) scale, confirmed by clinical evaluation.
- Participants presenting a stratum corneum hydration index between 35 and 55 arbitrary units (AU), as measured by corneometry on the forearm during the eligibility assessment.
- Participants considered healthy by the investigator, with no medical conditions or use of medications that could pose an undue risk or interfere with the study results.
- Willingness to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
- Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
Exclusion Criteria:
- Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study, when applicable.
- Use of anti-inflammatory, immunosuppressive, antihistamine, or any other medication that, in the investigator's opinion, may interfere with skin condition assessments or study outcomes.
- Presence of skin marks in the test area that may interfere with clinical or instrumental evaluations of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- Presence of active atopic dermatitis, eczema, or other dermatoses that may interfere with evaluation of the test area.
- Active localized or generalized skin diseases and/or lesions in the assessment area that, in the investigator's opinion, may compromise participation in the study.
- Immunosuppression due to medication use or active disease.
- Uncontrolled endocrine disorders.
- Presence of significant vascular alterations in the lower limbs, such as severe venous insufficiency, significant edema, lymphedema, or ulcers that may interfere with study assessments.
- Relevant medical history or current evidence of alcohol or substance abuse.
- Known history of or suspected intolerance to products of the same category.
- Intense sun exposure within 15 days prior to the baseline assessment.
- Aesthetic or dermatological treatments within 4 weeks prior to the baseline assessment.
- Procedures that may temporarily alter skin condition in the test area, such as exfoliation or hair removal, within the timeframe specified by the study protocol.
- Any other condition that, in the investigator's opinion, may pose a risk to the participant, interfere with protocol compliance, or compromise the interpretation of study results.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Investigational Product Group
Participants with moderate to severe xerosis of the lower limbs will apply the investigational moisturizing product twice daily for 28 days.
Dermatological, subjective, and instrumental assessments will be performed to evaluate skin tolerability, hydration, and skin barrier function.
|
A topical moisturizing product intended for the management of xerosis.
The product will be applied twice daily to the lower limbs for 28 consecutive days.
Its dermatological acceptability, effects on skin hydration, and effects on skin barrier recovery and strengthening will be evaluated through clinical, subjective, and instrumental assessments, including Corneometer® and Tewameter® measurements.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
기간: Baseline and Day 28
|
Dermatological acceptability of the investigational product under real-world conditions of use, including the assessment of signs of skin irritation and participant-reported discomfort sensations.
Evaluations will be performed by a dermatologist throughout the study period.
|
Baseline and Day 28
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Skin Hydration Assessed by Corneometer®
기간: Immediately after application, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after a single application.
|
Evaluation of skin hydration following a single application of the investigational product using Corneometer®.
Skin hydration will be measured in arbitrary units (AU), with higher values indicating greater skin hydration.
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Immediately after application, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 12 hours, 24 hours, and 48 hours after a single application.
|
|
Skin Barrier Recovery Assessed by Tewameter® Following Tape Stripping
기간: Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.
|
Evaluation of skin barrier recovery following barrier disruption induced by tape stripping and a single application of the investigational product.
Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL).
Lower TEWL values indicate improved skin barrier recovery and function.
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Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.
|
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Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire Following Tape Stripping
기간: Immediately after application, 1 hour, and 2 hours after a single application.
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Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire following skin barrier disruption induced by tape stripping and a single application of the product.
Participants will report the intensity of symptoms and sensations, such as burning sensation, using response categories ranging from "Absent" to "Very Intense."
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Immediately after application, 1 hour, and 2 hours after a single application.
|
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Skin Barrier Strengthening Assessed by Tewameter®
기간: Day 7 and Day 28
|
Evaluation of skin barrier strengthening following continuous use of the investigational product.
Skin barrier function will be assessed using Tewameter® measurements of transepidermal water loss (TEWL) after 7 and 28 days of product use.
Lower TEWL values indicate improved skin barrier function and strengthening of the skin barrier.
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Day 7 and Day 28
|
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Skin Hydration Assessed by Corneometer®
기간: Day 7 and Day 28
|
Evaluation of the efficacy of the investigational product in improving skin hydration following continuous use.
Skin hydration will be measured using Corneometer® and reported in arbitrary units (AU).
Higher values indicate greater skin hydration and a better outcome.
|
Day 7 and Day 28
|
|
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire
기간: Day 7 and Day 28
|
Evaluation of the performance and attributes of the investigational product using a perceived efficacy questionnaire after 7 and 28 days of product use.
Responses will be recorded using a 5-category agreement scale ranging from "Strongly Disagree" to "Strongly Agree."
|
Day 7 and Day 28
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sergio Schalka, Grupo Medcin
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 14일
기본 완료 (추정된)
2026년 11월 17일
연구 완료 (추정된)
2026년 11월 17일
연구 등록 날짜
최초 제출
2026년 9월 10일
QC 기준을 충족하는 최초 제출
2026년 9월 10일
처음 게시됨 (실제)
2026년 9월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 15일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 26-0197-06
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
No plan has been established to share individual participant data (IPD) collected during this study.
Participant confidentiality and privacy will be protected in accordance with applicable regulations and institutional policies.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .