Evaluation of the Safety and Efficacy of the Product Bepantol® Cream After the Dermatological Procedure in the Face.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Skin barrier integrity by TEWL probe
研究概览
简要总结
In this study, researchers want to learn more about the effect of dexpanthenol cream on skin recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the face for treatment of fine wrinkles, scars and open pores in adult women.
After the dermatological procedure, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such as redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol cream.
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 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 (ablative laser) on the face for treatment of fine wrinkles, scars and open pores, rosacea
- •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 and cutaneous marks 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
- •People with entropy, ectropion, stye, conjunctivitis, uveitis or other active eye diseases
- •People with corneal ulcerations, blepharitis, meibomitis, pterygium, trichiasis, distichiasis or other eye diseases of moderate or serious intensity
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) (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 BAY207543 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) (Drug)
Women_Hemiface Vaseline
Adult women receive BAY207543 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
Skin barrier integrity 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)
时间窗: Up to 23 days
次要结局
- Product evaluation(Up to 23 days)
- Severity of adverse events by ophthalmologic valuation(Up to 23 days)
- Skin properties of the participants(Up to 23 days)
- Number of adverse events by ophthalmologic valuation(Up to 23 days)
- Severity of adverse events by dermatological evaluation(Up to 23 days)
- Treatment satisfaction(Up to 23 days)
- Number of adverse events by dermatological evaluation(Up to 23 days)