An Open Label, Non-randomized, Single-Centre, Single Arm Study to evaluate the potential allergies to Seridermâ„¢ Non-adherent absorbent wound dressing device of Serigen Mediproducts Pvt. Ltd. by conducting Skin Prick Test in healthy adult human subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To evaluate the allergic reactions of Seridermâ„¢ Non-adherent absorbent
研究概览
简要总结
The study was initiated on 28 Oct 2024. Total of 25 subjects were enrolled in the study. Study was completed on 29 Oct 2024. Total of 25 subjects completed the study. Overall, the data indicate that the Seriderm® non-adherent absorbent wound dressing did not have significant allergic reactions after skin prick test over the course of the study. The negative control did not produce the same reaction as the positive control. The positive control exhibited a significantly stronger reaction compared to both the negative control and the test product. No statistically significant difference was observed between the reactions of the negative control and the test product. The negative control sites showed a wheal size of "0 mm" in all subjects, while the positive control sites had an average wheal size of "5.480 mm at 15 minutes assessment after prick, 2.200 mm at 6 hours assessment after prick and 0.360 mm at 24 hours assessment after prick". Both controls confirm the sensitivity and specificity of the test. No AEs/SAEs were reported in the study. All the subjects vital signs were within normal ranges throuhout the study.
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 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adult, human volunteers, of either sex, aged above 18 years.
- •2.Completed written informed consent and receive a copy of their executed ICD.
- •Volunteers must be capable of understanding.
- •Body mass index of  18.50 kg/m2 and ï‚£ 30.00 kg/m2 (inclusive of both) and weight  50 kgs for male subjects and  45 kgs for female subjects.
- •Volunteers with no known allergic reactions
- •Volunteers willing to give written informed consent and adhere to all the requirements of the protocol.
排除标准
- •Pregnancy or lactation
- •Inadequate or non-existent contraception (women of child bearing potential only).
- •A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis).
- •Volunteers known, or thought to be hypersensitivity to test product.
- •Current use or history of repeated use of recreational drugs.
- •Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease.
- •7.0Participation in a Human Repeat Insult Patch Test (HRIPT), Skin Prick Test (SPT) or followup work within the last month.
结局指标
主要结局
To evaluate the allergic reactions of Seridermâ„¢ Non-adherent absorbent
时间窗: The outcome will be assessed at 15 minutes, 6 hours & 24 hours after skin prick
wound dressing device by skin prick test.
时间窗: The outcome will be assessed at 15 minutes, 6 hours & 24 hours after skin prick
次要结局
- Monitoring of adverse events and change in vital signs.(Through out the study.)
研究者
Dr D Tejo Swaroop Kumar
Noah Therapeutics Private Limited