Comparison of the Effect of Vaseline and Bepanthen® "Wund- Und Heilsalbe" on the Wound Healing Following Laser Therapy (CO2)

• ClinicalTrials.gov Identifier: NCT03095872
• Recruitment Status: Completed
• First Posted: March 30, 2017
• Last Update Posted: May 30, 2018
• Sponsor: RWTH Aachen University
• Information provided by (Responsible Party): RWTH Aachen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Photodamaged Skin	Device: CO2-laser; Drug: Vaseline; Drug: Bepanthen	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: March 1, 2017
• Actual Primary Completion Date: January 22, 2018
• Actual Study Completion Date: February 5, 2018

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Device: CO2-laser; Patients with photo-damaged skin are treated with the CO2 laser to remove damaged skin layers.; Drug: Vaseline; After the laser treatment, the wound area will be divided into two parts with a sterile skin marker. One area will be treated with Vaseline, and be marked "V". Thus, it is ensured that the care product will be applied correctly to the defined area. Postoperatively, this area of the wound will be treated with Vaseline. In the next seven days the patient will repeat the treatment every day at home.; Drug: Bepanthen; After the laser treatment, the wound area will be divided into two parts with a sterile skin marker. One area will be treated with Bepanthen® Wund- und Heilsalbe, and be marked "B". Thus, it is ensured that the care product will be applied correctly to the defined area. Postoperatively, this area of the wound will be treated with Bepanthen® Wund- und Heilsalbe. In the next seven days the patient will repeat the treatment every day at home.

Outcome Measures

Primary Outcome Measures :

1. Change of the diameter of the individual lesions [initial value 1.3mm] between study visits. [ Time Frame: 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.
2. Change of the size of the individual lesions between study visits. [ Time Frame: 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.
3. Visual changes of the wound healing between study visits. [ Time Frame: 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.
4. Change of the wound under cosmetic aspects between study visits. [ Time Frame: 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).

Secondary Outcome Measures :

1. Change of the transepidermal water loss (TEWL) between study visits. [ Time Frame: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment) ]
   TEWL is the most important parameter for the assessment of skin barrier function.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

University Hospital RWTH Aachen

Aachen, NRW, Germany, 52057

Sponsors and Collaborators

RWTH Aachen University

Investigators

• Principal Investigator: Jens M. Baron, Prof. Dr. med.; RWTH Aachen University, Department of Dermatology and Allergology

More Information

Additional Information:

Leitlinie zur Behandlung der aktinischen Keratosen C44.X der Deutschen Dermatologischen Gesellschaft. 

Publications:

Bogdan Allemann I, Kaufman J. Laser principles. Curr Probl Dermatol. 2011;42:7-23. doi: 10.1159/000328236. Epub 2011 Aug 16.

Reinholz M, Tietze JK, Kilian K, Schaller M, Schöfer H, Lehmann P, Zierhut M, Klövekorn 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. English, German.

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.

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.

• Responsible Party: RWTH Aachen University
• ClinicalTrials.gov Identifier: NCT03095872
• Other Study ID Numbers: 16-011
• First Posted: March 30, 2017
• Last Update Posted: May 30, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by RWTH Aachen University:

photodamaged skin; wound healing; CO2 laser

Additional relevant MeSH terms:

Petrolatum; Emollients; Dermatologic Agents