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

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095872


Locations
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Germany
University Hospital RWTH Aachen
Aachen, NRW, Germany, 52057
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Jens M. Baron, Prof. Dr. med. RWTH Aachen University, Department of Dermatology and Allergology
Additional Information:
Publications:
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03095872    
Other Study ID Numbers: 16-011
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Petrolatum
Emollients
Dermatologic Agents