A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)
研究概览
简要总结
A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium Lauryl Sulfate) and a negative control (Saline).
The primary objective of this study is to determine if any subjects exhibit an allergic reaction which may be indicative of a pre-existing sensitization.
详细描述
Following approximately 48 hours of continuous skin contact, the patch units and test material are removed at the testing facility. The test sites are evaluated for a significant reaction according to the ESS (Erythemal Scoring Scale).
The test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction) using the ESS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be 18 to 79 years inclusive.
- •Subjects must be able to understand and execute informed consent.
- •Female subjects must produce a negative pregnancy test.
- •Subjects must be capable of following directions.
- •Subjects must be considered reliable .
排除标准
- •Subjects who are ill of health or taking medication that could influence the purpose, integrity, or outcome of the trial.
- •Female subjects who are pregnant.
- •Subjects with a history of adverse reactions to cosmetics, OTC (over the counter) drugs or other personal care products.
- •Subjects who have used topical or systemic steroids or antihistamines within 7 days prior to trial initiation or plan to use either during the duration of the trial.
- •Subjects with known allergy to neomycin, bacitracin, gentamicin, paromomycin, spectinomycin, streptomycin or tobramycin.
- •Subjects with known allergy to corticosteroid.
- •Subjects with a history of auto-immune disease (e.g. lupus, psoriatic arthritis, rheumatoid arthritis).
研究组 & 干预措施
Patch Test Group
All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.
Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.
干预措施: Neo-Synalar Cream (Drug)
Patch Test Group
All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.
Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.
干预措施: Sodium Lauryl Sulfate Aqueous Solution (0.40%) (Other)
Patch Test Group
All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.
Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.
干预措施: Saline (Other)
结局指标
主要结局
Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)
时间窗: 48, 96 and 168 Hours
ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). "0"= no visible erythema; "0.5"= slight, barely perceptible erythema; "1"= mild erythema; "2"= moderate erythema; "3"= marked erythema; "4"= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization.
次要结局
未报告次要终点
研究者
Noah Rosenberg, MD
Chief Medical Officer
Medimetriks Pharmaceuticals, Inc