Evaluation of the Safety and Efficacy of the Product Bepantol® Derma Spray After the Dermatological Procedure in the Face - 21 Days of Follow-up.
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 and reduction of skin redness after a dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars, open pores and change of pigmentation.
After the dermatological procedure, 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 and reduction of erythema after non-ablative lasering on the face.
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
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Phototypes I or II according to the Fitzpatrick scale
- •Participants willing to perform the dermatological procedure (non-ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea, poikiloderma, and melasma
- •Normal eye examination
排除标准
- •Cutaneous pathologies and/or injuries as psoriasis, sensible skin, cancer of the skin, rosacea, atopic dermatitis or other medical criteria to be considered at the moment of the evaluation;
- •Hyperpigmentation in the test area that intervenes with the evaluation of possible reactions
- •Active cutaneous pathologies and/or injuries (local and/or disseminated) in the evaluation area
- •Aesthetic or dermatological treatment in the area of evaluation up to 04 weeks before the selection
研究组 & 干预措施
Women_Hemiface BAY207543
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with BAY207543 is investigated.
干预措施: BAY207543 (Bepanthol, Bepantol® Derma Spray) (Drug)
Women_Hemiface BAY207543
Adult women receive BAY207543 randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with BAY207543 is investigated.
干预措施: Semisolid vaseline (Other)
Women_Hemiface Vaseline
Adult women receive the test product randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface with vaseline is investigated.
干预措施: BAY207543 (Bepanthol, Bepantol® Derma Spray) (Drug)
Women_Hemiface Vaseline
Adult women receive the test product randomized to one hemiface and semisolid vaseline to the other hemiface after ablative skin lasering. The hemiface 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.
Dermic temperature by thermographic camera (FLIR T530sc)
时间窗: Up to 23 days
次要结局
- Severity 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)
- Number of adverse events by dermatological evaluation(Up to 23 days)
- Number of adverse events by ophthalmologic valuation(Up to 23 days)
- Severity of adverse events by ophthalmologic valuation(Up to 23 days)