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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in minimal erythema dose (MED) after application of 2% and 4% cucumber seed extract compared with placebo
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Filipinos aged 18 to 59 years with Fitzpatrick skin phototypes III to V were included in the study.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Placebo gel (Drug)
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.
干预措施: 2% cucumber seed gel (Drug)
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.
干预措施: 4% cucumber seed gel (Drug)
Randomized Test Site on Back 2
干预措施: Placebo gel (Drug)
Randomized Test Site on Back 2
干预措施: 2% cucumber seed gel (Drug)
Randomized Test Site on Back 2
干预措施: 4% cucumber seed gel (Drug)
Randomized Test Site on Back 3
干预措施: Placebo gel (Drug)
Randomized Test Site on Back 3
干预措施: 2% cucumber seed gel (Drug)
Randomized Test Site on Back 3
干预措施: 4% cucumber seed gel (Drug)
结局指标
主要结局
Change in minimal erythema dose (MED) after application of 2% and 4% cucumber seed extract compared with placebo
时间窗: 24 hours post application
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.
次要结局
- Adverse events such as pain, pruritus, tenderness, burning, blistering, or irregular pigmentation (Composite secondary outcome)(24 and 48 hours after application)
研究者
Claudine Kay M. Fernandez
Principal Investigator
DOH - Tondo Medical Center