Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Transepidermal water loss by TEWL probe
研究概览
简要总结
In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.
After the peeling, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.
详细描述
The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region.
Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Phototypes I and II according to the Fitzpatrick scale;
- •Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.
排除标准
- •Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
- •Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
- •Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
研究组 & 干预措施
Women_Inguinal side BAY207543
Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with BAY207543 will be investigated.
干预措施: BAY207543 (Bepanthol, Bepantol® Derma Spray) (Drug)
Women_Inguinal side BAY207543
Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with BAY207543 will be investigated.
干预措施: Semisolid vaseline (Other)
Women_Inguinal side Vaseline
Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with the vaseline will be investigated.
干预措施: BAY207543 (Bepanthol, Bepantol® Derma Spray) (Drug)
Women_Inguinal side Vaseline
Adult women apply BAY207543 to one side of the inguinal region, and semisolid vaseline to the the opposite side after skin peeling. The area with the vaseline will be investigated.
干预措施: Semisolid vaseline (Other)
结局指标
主要结局
Transepidermal water loss by TEWL probe
时间窗: Up to 23 days
The transepidermal water loss (TEWL) is measured in g m2 h-1 with a Tewameter TM300.
次要结局
- Skin properties of the participants(Up to 23 days)
- Treatment satisfaction(Up to 23 days)
- Product evaluation(Up to 23 days)
- Number of adverse events by gynecological evaluation(Up to 23 days)
- Severity of adverse events by dermatological evaluation(Up to 23 days)
- Number of adverse events by dermatological evaluation(Up to 23 days)
- Severity of adverse events by gynecological evaluation(Up to 23 days)