Dermatological Acceptability and Efficacy in Improving Xerosis, Skin Hydration, and Barrier Function
2026年9月15日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
22
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Layane Melody Da Silva Reis Cavalcante
- 電話番号：+55 (11) 4507-2183
- メール：layane.reis@brainfarma.ind.br
研究場所
-
-
São Paulo
-
Osasco、São Paulo、ブラジル、06023-070
- 募集
- Grupo Medcin
-
コンタクト：
- Camila Canale
- 電話番号：+55 (11) 98343 6952
- メール：camila.canale.ext@medcin.com.br
-
主任研究者：
- Sergio Schalka
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dermatological Acceptability Assessed by Clinical Dermatological Evaluation
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Skin Hydration Assessed by Corneometer®
時間枠：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.
|
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
時間枠：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.
|
Immediately after application, 1 hour, 2 hours, and 4 hours after a single application.
|
|
Perceived Product Performance Assessed by a Perceived Efficacy Questionnaire Following Tape Stripping
時間枠：Immediately after application, 1 hour, and 2 hours after a single application.
|
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."
|
Immediately after application, 1 hour, and 2 hours after a single application.
|
|
Skin Barrier Strengthening Assessed by Tewameter®
時間枠：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.
|
Day 7 and Day 28
|
|
Skin Hydration Assessed by Corneometer®
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Sergio Schalka、Grupo Medcin
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月14日
一次修了 (推定)
2026年11月17日
研究の完了 (推定)
2026年11月17日
試験登録日
最初に提出
2026年9月10日
QC基準を満たした最初の提出物
2026年9月10日
最初の投稿 (実際)
2026年9月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月16日
QC基準を満たした最後の更新が送信されました
2026年9月15日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 26-0197-06
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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