Evaluation of Irritation Potential of MOISTURE IQ through Dermatological Evaluation by Single Occlusive Patch Test on Healthy Adult Human Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Outcome
研究概览
简要总结
Inclusion Criteria:
Healthy volunteers with clear skin (no eczema, wounds, or scars) on the studied area.
Age 18-55, with 12 male and 12 female volunteers.
Full compliance with study procedures.
Exclusion Criteria:
Pregnant or lactating women.
Volunteers with any skin disorders.
Use of any topical agents on the application site within the past 30 days.
Methodology
The study will involve 24 healthy adult volunteers (12 males and 12 females) aged 18-55 years, selected according to protocol guidelines. The procedure includes applying a patch containing Finn’s chamber on the back or shoulder area of the volunteers. Each chamber will hold 25 microlitres of the test product and one positive control. The patch will remain in contact with the skin for 24 hours. If any allergic reactions occur, the patch can be removed within 24 hours, and the investigator will be notified immediately. All procedures will be conducted as per the study protocol.
Examination Schedule Overview:
Screening: Registration, consent, health check, and dermatologist approval.
T0 (Pre-application): Acclimatization, patch application, AE/SAE monitoring.
T1 (0 hrs post-patch removal): Acclimatization, patch removal, AE/SAE monitoring.
T2 (24 hrs post-patch removal): Acclimatization, dermatological evaluation, AE/SAE monitoring.
T8 (1 week post-patch removal): Acclimatization, final dermatological evaluation, AE/SAE monitoring, and review of positive cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy participants with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar) 2.Age group of 18 to 55 years, 12 male and 12 female participants.
- •3.Compliance with the study procedures involved.
排除标准
- •1.Pregnant and lactating women 2.Participants with any other skin disorders.
- •3.Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.
结局指标
主要结局
Outcome
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
1. Erythema, dryness, wrinkles
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
Oedema
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
2. Mean Irritation Index
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
Scoring System (0-4):
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
0: No reaction
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
1: Very slight erythema/dryness/oedema
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
2: Slight erythema/dryness/oedema
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
3: Moderate erythema/dryness/oedema
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
4: Severe erythema/dryness/oedema
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
Evaluation Process:
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
3. Mean scores for erythema, dryness, wrinkles, and oedema will be
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
calculated for T1, T2, and T8 days using Microsoft Excel 2010 and
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
GraphPad Prism software.
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
4. Scores will be assessed for the test sample (Vanaura Organics
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
Products) and controls (including 1% sodium lauryl sulfate).
时间窗: T1 (0 Hours Post-Patch Removal) | T2 (24 Hours Post-Patch Removal) | T8 (1 Week Post-Patch Removal)
次要结局
- Adverse event monitoring(T1 (0 Hours Post-Patch Removal))
研究者
Dr Sakthi Balan
DK Elite Health Care Centre