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Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women

2026年6月2日 更新者：Hospital Israelita Albert Einstein

The goal of this clinical trial is to evaluate whether the use of dermocosmetics containing Bioceramides and Niacinamide can improve post-inflammatory hyperpigmentation and promote positive impacts on self-esteem and quality of life in Brazilian Black women with facial hyperpigmentation (Fitzpatrick skin types IV to VI).

The main questions it aims to answer are:

  • Does the treatment improve hyperpigmentation severity as measured by HASI and IGA scores?
  • Does the treatment improve participants' self-esteem and quality of life as assessed by MELASQoL and DLQI questionnaires?

Participants will:

  • Use a standardized skincare routine including cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen for 12 weeks.
  • Attend study visits at baseline, week 6, and week 12.
  • Undergo standardized facial photography and clinical assessments by specialists at baseline, week 6, and week 12.
  • Complete questionnaires related to self-esteem and quality of life at baseline, week 6, and week 12.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

60

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

研究連絡先のバックアップ

研究場所

  • ブラジル
    • São Paulo
      • São Paulo、São Paulo、ブラジル、05652-900
        • 募集
        • Hospital israelita Albert Einstein
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • Bruna Cestari de Azevedo, PhD

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

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Female participants aged 18 to 55 years
  • Clinical diagnosis of facial post-inflammatory hyperpigmentation (PIH)
  • Self-identified as Black (including "preta" or "parda")
  • Fitzpatrick skin types IV to VI
  • Employees, students, or affiliated personnel of Hospital Israelita Albert Einstein (including contractors and fellows), recruited from institution units
  • Willing and able to comply with all study procedures and attend all scheduled visits
  • Able and willing to provide written informed consent and authorization for image use

Exclusion Criteria:

  • Pregnant or breastfeeding women, or those planning pregnancy during the study period
  • Type 1 diabetes mellitus or related complications (e.g., nephropathy, dermatological conditions associated with diabetes, history of hypoglycemia, diabetic ketoacidosis, or hyperosmolar coma)
  • Known or suspected intolerance to similar cosmetic products
  • History of atopy or allergic reactions to cosmetic products
  • Personal or family history of skin cancer
  • Active skin conditions or lesions affecting the face
  • Facial marks or scars that may interfere with assessments
  • Skin irritation due to recent sun exposure
  • Excessive sun or UV exposure, including artificial tanning, within the past month
  • Use of facial cosmetic products within 7 days before screening
  • Use of topical or systemic treatments within 1 month before screening
  • Use of depigmentation treatments within 3 months before screening
  • Use of dermocosmetic treatments for PIH within 3 months before screening
  • Facial dermatological or aesthetic procedures within 2 weeks before screening
  • Use of corticosteroids, anticoagulants, or immunosuppressive drugs
  • Score ≥5 indicating anxiety or depression on Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder scale (GAD-7)
  • Any other condition that, in the investigator's judgment, may compromise study participation or results (to be documented in the medical record)

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：Intervention

Participants will receive a standardized facial skincare regimen to be used daily for 12 weeks, including a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen (non-investigational). Products will be used daily, with cleanser twice daily, moisturizer in the morning, serum at night, and sunscreen twice daily.

Participants will undergo evaluations at baseline, week 6, and week 12, including standardized photography and assessment using Hyperpigmentation Area Severity Scale (HASI) and Investigator's Global Assessment (IGA). Quality of life will be assessed with Melasma Quality of Life Scale (MelasQoL) and Dermatology Life Quality Index (DLQI). Participants will complete daily diaries to record product use and any reactions during the study, and will assess perceived product efficacy at the final visit.
薬：Niacinamide and Bioceramide-Based Skincare Regimen
A standardized facial skincare regimen containing a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen. The products are intended for daily use, with cleanser applied twice daily, moisturizer applied in the morning, serum applied at night, and sunscreen applied twice daily.

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
Change in Hyperpigmentation Severity Assessed by Hyperpigmentation Area Severity Scale (HASI)
時間枠：Baseline, Week 6, and Week 12
The Hyperpigmentation Area Severity Scale (HASI), adapted from the Melasma Area Severity Index (MASI), will be used to evaluate pigmentation severity. The face will be divided into four regions (forehead, right malar, left malar, and chin). Hyperpigmentation severity will be assessed based on three components: pigmentation intensity and homogeneity (both scored from 0 to 4), and the affected area (scored from 0 to 6). A weighted sum will be calculated for each region using the following formula: HASI = 0.3 × (area score) × (intensity + homogeneity) for the forehead and malar regions, and 0.1 × (area score) × (intensity + homogeneity) for the chin. The total HASI score will be obtained by summing all regions, ranging from 0 to 48, with higher scores indicating greater hyperpigmentation severity.
Baseline, Week 6, and Week 12
Visual Assessment of Post-Inflammatory Hyperpigmentation Using Standardized Facial Photography
時間枠：Baseline, Week 6, and Week 12
Standardized facial photographs will be obtained at each study visit and will be evaluated by a dermatologist to assess post-inflammatory hyperpigmentation. Images will be captured under visible light using a standardized protocol (Rossi et al., 2011), including three facial views (frontal, left 45°, and right 45°). The face will be divided into seven regions for visual analysis and quantification of pigmented areas using ImageJ software (version 1.45p, NIH). All photographs will be acquired using consistent camera settings, lighting conditions, and participant positioning throughout the study to ensure comparability.
Baseline, Week 6, and Week 12
Change in Hyperpigmentation Severity Assessed by Investigator's Global Assessment (IGA)
時間枠：Baseline, Week 6, and Week 12
The Investigator's Global Assessment (IGA) is a visual assessment that will be used to provide an overall evaluation of post-inflammatory hyperpigmentation severity. Assessments will be performed by a dermatologist using a 6-point scale ranging from 0 to 5, according to morphological characteristics of pigmentation: 0 = no hyperpigmentation; 1 = almost clear; 2 = mild but noticeable hyperpigmentation; 3 = moderate hyperpigmentation (medium brown); 4 = severe hyperpigmentation (dark brown); and 5 = very severe hyperpigmentation (very dark brown to nearly black). Higher scores will indicate greater severity of pigmentation.
Baseline, Week 6, and Week 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Quality of Life Assessed by Melasma Quality of Life Scale (MelasQoL)
時間枠：Baseline, Week 6, and Week 12
The Melasma Quality of Life Scale (MelasQoL) will be used to assess quality of life related to post-inflammatory hyperpigmentation. The questionnaire consists of 10 items divided into three domains: emotional well-being, social life, and self-esteem/daily activities. Each item is scored from 1 (not bothered at all) to 7 (constantly bothered), with higher scores indicating worse quality of life. The MelasQoL is a validated instrument for assessing the impact of melasma and other pigmentary disorders on patients' quality of life.
Baseline, Week 6, and Week 12
Change in Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
時間枠：Baseline, Week 6, and Week 12
The Dermatology Life Quality Index (DLQI) will be used to assess quality of life and self-esteem related to post-inflammatory hyperpigmentation. The questionnaire consists of 10 items covering six domains: symptoms, emotions, daily activities, work/school, social functioning, and treatment. Each item is scored from 0 (not at all/not relevant) to 3 (very much), with total scores ranging from 0 to 30. Higher scores indicate greater impairment in quality of life.
Baseline, Week 6, and Week 12

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。

スポンサー

Hospital Israelita Albert Einstein

協力者

COTY BRASIL COMERCIO S.A.

捜査官

  • 主任研究者：Bruna Cestari de Azevedo, PhD、Hospital israelita Albert Einstein

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 (実際)

2026年3月19日

一次修了 (推定)

2026年10月31日

研究の完了 (推定)

2026年10月31日

試験登録日

最初に提出

2026年5月25日

QC基準を満たした最初の提出物

2026年5月25日

最初の投稿 (実際)

2026年6月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年6月2日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • COTY_10772

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

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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