Clinical trial NCT03095872: Comparison of the Effect of Vaseline and Bepanthen® "Wund- Und Heilsalbe" on the Wound Healing Following Laser Therapy
Official title: Comparison of the Effect of Vaseline and Bepanthen® "Wund- Und Heilsalbe" on the Wound Healing Following Fractional Ablative Laser Treatment of Photo-damaged Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Photodamaged Skin
Keywords: photodamaged skin
wound healing
CO2 laser
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* photodamaged skin, which need to be treated with the fractional ablative CO2 laser

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of the diameter of the individual lesions [initial value 1.3mm] between study visits.
timeFrame: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
measure: Change of the size of the individual lesions between study visits.
timeFrame: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
measure: Visual changes of the wound healing between study visits.
timeFrame: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
measure: Change of the wound under cosmetic aspects between study visits.
timeFrame: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
Secondary outcomes:
measure: Change of the transepidermal water loss (TEWL) between study visits.
timeFrame: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: RWTH Aachen University, Department of Dermatology and Allergology
name: Jens M. Baron, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bogdan Allemann I, Kaufman J. Laser principles. Curr Probl Dermatol. 2011;42:7-23. doi: 10.1159/000328236. Epub 2011 Aug 16.
citation: Reinholz M, Tietze JK, Kilian K, Schaller M, Schofer H, Lehmann P, Zierhut M, Klovekorn W, Ruzicka T, Schauber J. Rosacea - S1 guideline. J Dtsch Dermatol Ges. 2013 Aug;11(8):768-80; 768-79. doi: 10.1111/ddg.12101. Epub 2013 May 6. No abstract available. English, German.
citation: Marquardt Y, Amann PM, Heise R, Czaja K, Steiner T, Merk HF, Skazik-Voogt C, Baron JM. Characterization of a novel standardized human three-dimensional skin wound healing model using non-sequential fractional ultrapulsed CO2 laser treatments. Lasers Surg Med. 2015 Mar;47(3):257-65. doi: 10.1002/lsm.22341. Epub 2015 Mar 15.
citation: Wigger-Alberti W, Kuhlmann M, Ekanayake S, Wilhelm D. Using a novel wound model to investigate the healing properties of products for superficial wounds. J Wound Care. 2009 Mar;18(3):123-28, 131. doi: 10.12968/jowc.2009.18.3.39813.