A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation
2026年6月8日 更新者：Revision Skincare
A Multi-Center, Randomized, Blinded, Split-Face, Controlled Clinical Study to Assess Two Targeted Brightening Serum (A and B) Paired With 4% Hydroquinone
This a short four-week pilot study to measure the efficacy and tolerance of two brightening serums (cosmetics) versus 4% hydroquinone.
The study was conducted in two sites across the USA, one in PA and in one in CA.
The goal was to run the pilot study in the summer to understand the role of these two potential brightening serums in helping the appearance of skin tone evenness.
調査の概要
詳細な説明
This is a four-week multi-center, single-blind, randomized, split-face, controlled pilot study conducted to assess the efficacy and tolerance of two pigment correction formulations (Brightening Serum A and Brightening Serum B) compared to 4% Hydroquinone split face when used over the course of 4 weeks by healthy females with clinically determined mild to severe facial hyperpigmentation, including melasma on the global face. Subjects will be randomized into 2 cells which will receive the following split face treatments:
- Cell 1: Brightening Serum A versus 4% Hydroquinone
- Cell 2: Brightening Serum B versus 4% Hydroquinone It was hypothesized that the Brightening Serum A and B will produce statistically significant improvements at post-baseline timepoints when compared with baseline, and comparable improvements versus the standard of care 4% Hydroquinone across the primary endpoint, secondary and tertiary endpoints. Additionally, the Sponsor's test materials will be well tolerated by subjects, with no statistically significant increases in scores for tolerability/safety parameters, specifically erythema and dryness, at any study timepoint when compared with baseline scores. Furthermore, the Sponsor's test materials will be well perceived by subjects according to analyses of self-assessment questionnaires, with a statistically significant proportion of favorable responses compared to unfavorable responses and/or a statistically significant improvement in subject response values when compared with baseline.
研究の種類
介入
入学 (実際)
18
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。
研究場所
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Texas
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Irving、Texas、アメリカ、75063
- Revision Skincare
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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
はい
説明
Inclusion Criteria:
- In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
- Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type)
- Age 20 to 60 years.
- Subjects with self-perceived hyperpigmented facial skin
- Having mild to severe (score of 3-9 according to a modified Griffiths scale,2 where 0 = none, 1 to 3 = mild, 4 to 6 = moderate, 7 to 9 = severe) full-face hyperpigmentation, including melasma. Hyperpigmentation and melasma must present at equal severity and size on each facial side.
- Willing to maintain visit 1/baseline condition of eyebrows and eyelashes (do not noticeably change brow/lash appearance) during the study.
- Willing to provide written informed consent and able to read, speak, write, and understand English.
- Willing to sign a photography release.
- Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.
Exclusion Criteria:
- Having been diagnosed with known allergies to skin care products.
- Having a known reactivity to tranexamic acid, niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, yeast, ascorbic acid, tetrahexyldecyl ascorbate, and/or any of the ingredients in the study products.
- Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
- Having a history of skin cancer within the past 5 years.
- Currently taking oral or topical prescription medications for melasma such as Triluma, compounded hydroquinone, retinoids, and tranexamic acid.
- Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, bactrim, tetracycline, erythromycin, vibramycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.
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：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Brightening Serum A
The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
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Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
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アクティブコンパレータ：Brightening Serum B
The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
|
他の：4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
|
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
|
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 |
|---|---|---|
|
Measurement of Clinical Efficacy Parameters by Clinical Grader
時間枠：Baseline, week 2, week 4
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Clinical grading efficacy parameters measured by blinded clinical grader including skin tone evenness, hyperpigmentation on the global face, and overall appearance.
Grading was performed on a 10-point Griffith's scale, where 0 = best possible outcome 9= severe skin condition.
A decrease in score/ value indicates an improvement.
|
Baseline, week 2, week 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measurement of Global Melasma Severity Assessment Score (GMSA)
時間枠：baseline and weeks 2 and 4
|
The expert grader (Board-Certified Dermatologist) will evaluate the right and left facial side using a Global Melasma Severity Assessment (GMSA) according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition. 0 = clear
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baseline and weeks 2 and 4
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Measurement of facial Melasma
時間枠：Baseline, week 2 and week 4
|
The MASI score is a clinical tool used to assess the severity of melasma, a hyperpigmentation disorder, in terms of both area and darkness.
It quantifies the extent and intensity of melasma in four facial regions: the forehead (F), right malar region (MR), left malar region (ML), and chin (C), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively.
A decrease in score indicates improvement
|
Baseline, week 2 and week 4
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Incidence of Treatment- Emergent Adverse Events
時間枠：Baseline, week 2, and week 4
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Local cutaneous tolerability was evaluated by assessing the signs and symptoms of the following objective and subjective irritation parameters globally on each subject's face.
Objective irritation (clinically graded): erythema, edema, and dryness.
Subjective irritation (assessed by subjects): burning, stinging, and itching.
Local cutaneous tolerability was evaluated by assessing objective (erythema, edema, and dryness) and subjective (burning, stinging, and itching) irritation parameters globally on each subject's face using a 4-point scale (0 = none to 3 = severe).
A decrease in value indicates an improvement.
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Baseline, week 2, and week 4
|
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
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)
2025年8月11日
一次修了 (実際)
2025年11月12日
研究の完了 (実際)
2025年11月12日
試験登録日
最初に提出
2026年6月3日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12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8日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 07242025
- Revision Skincare, LLC (その他の助成金/資金番号：Revision Skincare, LLC)
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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