Comparison of the Effect of Vaseline and Bepanthen® "Wund- Und Heilsalbe" on the Wound Healing Following Fractional Ablative Laser Treatment of Photo-damaged Skin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change of the diameter of the individual lesions [initial value 1.3mm] between study visits.
研究概览
简要总结
In the field of dermatology the healing process and therefore the success of a laser treatment are strongly determined by an appropriate postoperative treatment of the laser-treated skin. The manufacturer of CO2 laser systems recommends the application of Vaseline postoperatively to protect the treated tissue from air exposition until encrustation of the laser-treated skin decreases (usually after 7-14 days). An alternative to Vaseline could be Bepanthen® "Wund- und Heilsalbe" (Bayer). It contains the active ingredient pro-vitamin Dexapanthenol, which is widely used in dermatology therapy. The product helps to stabilize the protective barrier of the skin, to reduce the skin irritation, to stimulate the skin regeneration and to promote the wound healing. In an in-vitro study Bepanthen® "Wund- und Heilsalbe" triggered wound closure significantly faster compared to Vaseline. In this study the effect of Bepanthen® "Wund- und Heilsalbe" on wound healing should be investigated and compared to Vaseline in vivo following fractional ablative CO2 laser treatment of photo-damaged skin.
详细描述
The healing process and therefore the success of a laser treatment are strongly determined by an appropriate treatment with special skin care products of the laser-treated skin. Cooling measures prevent the swelling of the treated skin area, if applied directly after the procedure. A soothing and wound-healing-promoting care applied subsequently for seven days, can support and also speed up the healing process.
The Lumenis® Company is the manufacturer of CO2 laser systems and recommends the application of the Okklusiv ointment Vaseline® postoperatively, in order to prevent the treated tissue to the air exposition. These occlusive wound care should be maintained, until the encrustation of the laser-treated skin decreases, which usually happens 7-14 days postoperatively.
The Bepanthen® Wund- und Heilsalbe (Bayer) could be a possible alternative to Vaseline® as postoperative care. Bepanthen® Wund- und Heilsalbe contains pro-vitamin Dexpanthenol as an active ingredient and is widely used in dermatological therapy. The product helps to stabilize the protective barrier of the skin, to reduce the skin irritation, to stimulate the skin regeneration and to promote the wound healing. The investigators examined the effect of substances containing Dexpanthenol on wound healing process applied topically, in three-dimensional (3D) dermal skin equivalents in vitro. For this purpose, many lesions with standardized diameter and depth were generated using a laser. The subsequent topical application of substances containing dexpanthenol on the wound healing models (treated with laser) for three-days led to a significantly faster wound closure compared to Vaseline-covered models (Marquardt et al., 2015). The aim of this study is to compare the effect of white Vaseline with Bepanthen® "Wund- und Heilsalbe" (both applied postoperatively) on the wound healing following fractional ablative CO2 laser treatment of photo-damaged skin in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •photodamaged skin, which need to be treated with the fractional ablative CO2 laser
排除标准
- •pregnant or lactating females
- •chronic diseases such as diabetes and vascular disease with impaired wound healing
- •Patients, who tend to form hypertrophic scars and keloids
- •Patients, who take the isotretinoin-containing medication in the past year
- •topical or systemic corticosteroid treatment
- •immunocompromised patients
- •Patients with the Koebner phenomenon
- •People with the skin type 6
- •Patients with melanoma
研究组 & 干预措施
Bepanthen/Vaseline
One half of the wound occuring after CO2 laser therapy of photo-damaged skin is treated with Bepanthen and the other half with Vaseline.
干预措施: CO2-laser (Device)
Bepanthen/Vaseline
One half of the wound occuring after CO2 laser therapy of photo-damaged skin is treated with Bepanthen and the other half with Vaseline.
干预措施: Vaseline (Drug)
Bepanthen/Vaseline
One half of the wound occuring after CO2 laser therapy of photo-damaged skin is treated with Bepanthen and the other half with Vaseline.
干预措施: Bepanthen (Drug)
结局指标
主要结局
Change of the diameter of the individual lesions [initial value 1.3mm] between study visits.
时间窗: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
Large clinical digital photos as well as dermatoscopic images of the skin.
Change of the size of the individual lesions between study visits.
时间窗: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
Two-dimensional microscopic skin cut images in real time of the skin.
Visual changes of the wound healing between study visits.
时间窗: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
The wound healing rates will be visually assessed, based on the measure of re-epithelialization.
Change of the wound under cosmetic aspects between study visits.
时间窗: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
The cosmetic result is based on a visual analog scale (VAS) from 0 (bad) to 10 (excellent, with no visible difference of the wound to the surrounding tissue).
次要结局
- Change of the transepidermal water loss (TEWL) between study visits.(Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment))