A Clinical study to Evaluate the effectiveness of Reginald men Apollo Facewash for skin brightening and hydration
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 4. Change in TEWL
研究概览
简要总结
A single blind one arm study.
Each participant entering the trial will be assigned to a regimen of investigational product with the below assessments.
- Skin Gloss by Glossymeter (T0, T30min, T14Days, T28days)
- Skin Colour by Chromameter (T0, T14Days, T28days)
- Skin Pigmentation by Mexameter (T0 , T14days, T28 days)
- Skin Hydration with Corneometer (T0, T30min,T14days,T28days)
- TEWL for moisture barrier (T0, T30min,T14days,T28days)
- Dermat evaluation on a 5 point ordinal scale would be used for the blemishes (T0,T14and T28)
- Dermat evaluation on a 5 point ordinal scale would be used for the pore cleanliness post dermascope (T0, T14, T28)
- HD Imaging with DSLR or Visioscan (T0 and T28)
- Dermascopy Images ( T0 and T28day)
- Subject’s Self Assessments. (T28 only)
Male and Female with age 18-45 (80:20), Volunteers-36
Assessment Time: T0min, T+30 mins, T+14days, T+28 days
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
入选标准
- •Gender: Male and Female with age 18-45 (80:20) 2) Subjects with mild blemishes and dull skin.
- •Subjects willing to give written informed consent 4) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •1.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •2.Have open sores or open lesions in the treatment area(s).
- •3.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
- •4.Have participated in any interventional clinical trial in the previous 90 days.
- •5.Have a known sensitivity to any of the constituents of the test product including sensitivities.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
- •Have not skin related issues.
结局指标
主要结局
4. Change in TEWL
时间窗: At T0mins , T30mins, Day14 and T28days
5. Change in Skin discoloration
时间窗: At T0mins , T30mins, Day14 and T28days
6. Change in Skin Pigmentation
时间窗: At T0mins , T30mins, Day14 and T28days
3. Change in Skin hydration
时间窗: At T0mins , T30mins, Day14 and T28days
1. Change in skin brightness
时间窗: At T0mins , T30mins, Day14 and T28days
2. Change in Skin Softness
时间窗: At T0mins , T30mins, Day14 and T28days
次要结局
- SGA(At 28days)
研究者
Dr Robin Chugh
CCFT Laboratories
