Safety and Efficacy Evaluation of the Use of Bepantol® Derma Spray After Laser Depilation in the Inguinal Region in Adult Women - 21 Days Use at Home
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 35
- 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 for hair removal (laser depilation) in the groin and intimate area in adult women.
After the hair removal procedure, participants will return within 3 weeks for 3 visits to the study center to investigate the skin condition such as redness, irritation, softness of skin and possible side effects. Study participants will also 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 lasering depilation in the 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 a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the region
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
- •Hyperpigmentations 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 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with BAY207543 is investigated.
干预措施: BAY207543 (Bepanthol, Bepantol® Derma Spray) (Drug)
Women_Inguinal side BAY207543
Adult women apply BAY207543 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with BAY207543 is investigated.
干预措施: Semisolid vaseline (Other)
Women_Inguinal side Vaseline
Adult women apply BAY207543 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with vaseline is investigated.
干预措施: BAY207543 (Bepanthol, Bepantol® Derma Spray) (Drug)
Women_Inguinal side Vaseline
Adult women apply BAY207543 randomized to one side of the inguinal region and semisolid vaseline to the other side of the inguinal region after laser depilation. The side with vaseline is 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
- Number of adverse events by dermatological evaluation(Up to 23 days)
- Skin properties of the participants(Up to 23 days)
- Treatment satisfaction(Up to 23 days)
- Product evaluation(Up to 23 days)
- Severity of adverse events by dermatological evaluation(Up to 23 days)