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

NCT03095872 | Completed Phase 3

• 1 other identifier: 16-011
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Photodamaged Skin

Keywords

photodamaged skin; wound healing; CO2 laser

Outcome Measures

Primary Outcomes (4)

• Change of the diameter of the individual lesions [initial value 1.3mm] between study visits.

  Large clinical digital photos as well as dermatoscopic images of the skin.

  Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)

• Change of the size of the individual lesions between study visits.

  Two-dimensional microscopic skin cut images in real time of the skin.

  Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)

• Visual changes of the wound healing between study visits.

  The wound healing rates will be visually assessed, based on the measure of re-epithelialization.

  Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)

• Change of the wound under cosmetic aspects between study visits.

  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).

  Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)

Secondary Outcomes (1)

• 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)

Study Arms (1)

Bepanthen/Vaseline

EXPERIMENTAL

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; Drug: Vaseline; Drug: Bepanthen

Interventions

CO2-laser DEVICE

Patients with photo-damaged skin are treated with the CO2 laser to remove damaged skin layers.

Bepanthen/Vaseline

Vaseline DRUG

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.

Bepanthen/Vaseline

Bepanthen DRUG

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.

Bepanthen/Vaseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52057, Germany

Location

Related Publications (4)

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

  PMID: 21865794 BACKGROUND

• 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.

  PMID: 23647643 BACKGROUND

• 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.

  PMID: 25771913 BACKGROUND

• 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.

  PMID: 19247233 BACKGROUND

Related Links

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

MeSH Terms

Interventions

Lasers, Gas; Petrolatum; dexpanthenol

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Hydrocarbons; Organic Chemicals

Study Officials

• Jens M. Baron, Prof. Dr. med.

  RWTH Aachen University, Department of Dermatology and Allergology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 30, 2017
• Study Start: March 1, 2017
• Primary Completion: January 22, 2018
• Study Completion: February 5, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)