A Clinical Trial to Compare the Photoprotective Effects of Cucumber Seed Extract vs Placebo in Filipino Adults by Measurement of Minimal Erythema Dose
2026年7月30日 更新者：Claudine Kay M. Fernandez、DOH - Tondo Medical Center
A Double-blind Randomized Controlled Trial on the Photoprotective Effect of Cucumber (Cucumis Sativus) Seed Extract vs Placebo in Terms of Minimal Erythema Dose Among Filipino Adults
A monocentric, randomized, split-body, double-blind, controlled trial was conducted on 29 Filipino adults with Fitzpatrick skin types III-V.
Topical 2% and 4% cucumber seed extract gels and placebo were applied to randomized sites on the lower back, followed by incremental narrow-band UVB exposure.
MED was assessed 24 hours post-exposure.
Repeated measures ANOVA and paired t-tests were used for statistical analysis.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
29
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
-
-
National Capital Region
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Manila、National Capital Region、フィリピン、1003
- DOH-Tondo Medical Center Department of Dermatology and Venereology
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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:
- Filipinos aged 18 to 59 years with Fitzpatrick skin phototypes III to V were included in the study.
Exclusion Criteria:
- Elderly and pediatric populations were excluded due to differences in skin structure, immune responses, and the presence of age-related comorbidities that may confound study findings.
- Additional exclusions applied to individuals who were pregnant or breastfeeding;
- Had a history of phototoxic, photoallergic, or abnormal responses to sunlight; ----Reported allergies to cosmetic products, sunscreens, topical drugs, cucumber, or any study formulation component
- Participants were also excluded if they presented with pre-existing or dormant dermatologic conditions, sunburn, suntan, scars, active lesions, or uneven pigmentation on the lower back.
- Other exclusion criteria included current or recent use of medications known to cause hyperpigmentation (e.g., minocycline, clofazimine, amiodarone, antimalarials, chemotherapeutic agents), systemic treatments affecting skin status within the past 15-30 days, sun exposure of the lower back within four weeks prior to inclusion, or intake of skin-whitening supplements such as glutathione within one month before the study.
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：単一グループの割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Randomized Test Site on Back 1
Three test sites were delineated on each participant's lower back, and study treatments were randomly allocated to these sites using computer-generated randomization performed by a dermatology resident not involved in the trial.
Three MED test patches were applied on three sun-protected areas on the lower back.
The test patch had six windows of uniform sizes (2 cm × 2 cm) that were opened and exposed one at a time to incremental doses of excimer light.
The gels were applied by the research assistant on the designated randomized areas on the lower back.
The assistant researcher then applied the respective gels at an amount of 2 mg/cm2 (1/4 teaspoon) on each of the three test sites.
Gels were massaged to the skin until fully absorbed.
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The placebo gel serves as the base formulation is composed of: the oil phase of the formulation comprising of octadecanol, stearic acid, and liquid paraffin, while the aqueous phase consisted of distilled water, glycerin, and ethylparaben.
The two phases were emulsified and combined to make the base gel.
The assistant researcher then applied placebo gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 2% concentration.
The assistant researcher then applied 2% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 4% concentration.
The assistant researcher then applied 4% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
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実験的：Randomized Test Site on Back 2
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The placebo gel serves as the base formulation is composed of: the oil phase of the formulation comprising of octadecanol, stearic acid, and liquid paraffin, while the aqueous phase consisted of distilled water, glycerin, and ethylparaben.
The two phases were emulsified and combined to make the base gel.
The assistant researcher then applied placebo gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 2% concentration.
The assistant researcher then applied 2% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 4% concentration.
The assistant researcher then applied 4% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
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プラセボコンパレーター：Randomized Test Site on Back 3
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The placebo gel serves as the base formulation is composed of: the oil phase of the formulation comprising of octadecanol, stearic acid, and liquid paraffin, while the aqueous phase consisted of distilled water, glycerin, and ethylparaben.
The two phases were emulsified and combined to make the base gel.
The assistant researcher then applied placebo gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 2% concentration.
The assistant researcher then applied 2% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
Cucumber seed gel preparations were compounded by an FDA-registered pharmaceutical company which were incorporated into the placebo base gel at 4% concentration.
The assistant researcher then applied 4% cucumber seed gel at an amount of 2 mg/cm2 (1/4 teaspoon) on the designated randomized test site.
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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 |
|---|---|---|
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Change in minimal erythema dose (MED) after application of 2% and 4% cucumber seed extract compared with placebo
時間枠：24 hours post application
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After 24 hours post-application, the principal investigator examined previously irradiated sites.
A well-defined erythematous response at the lowest NBUVB dose was recorded as the MED, corresponding to E2 on the Visual Erythema Scale.
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24 hours post application
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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 |
|---|---|---|
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Adverse events such as pain, pruritus, tenderness, burning, blistering, or irregular pigmentation (Composite secondary outcome)
時間枠：24 and 48 hours after application
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Participants were also assessed after 24 and 48 hours regarding any experience of adverse events such as, but not limited to, pruritus, pain, tenderness, blistering, or irregular pigmentation immediately after and then 24 and 48 hours after application of gels.
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24 and 48 hours after application
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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。
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1月27日
一次修了 (実際)
2025年2月26日
研究の完了 (実際)
2025年2月28日
試験登録日
最初に提出
2026年7月17日
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月31日
QC基準を満たした最後の更新が送信されました
2026年7月30日
最終確認日
2026年7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
- REC-2024-00086
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?
はい
IPD プランの説明
All de-identified individual participant data might be shared.
IPD 共有時間枠
From: At the end of the study End: No end date
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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