Photodamaged SkinPhase 3CO2NCT03095872
Comparison of the Effect of Vaseline and Bepanthen® "Wund- Und Heilsalbe" on the Wound Healing Following Laser Therapy
A Phase 3 study testing CO2-laser, Vaseline and Bepanthen in people with Photodamaged Skin, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photodamaged Skin
- What is being tested?
- CO2-laser, Vaseline and Bepanthen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 5 Feb 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- photodamaged skin, which need to be treated with the fractional ablative CO2 laser
Who cannot join
- 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
Show all 9Show fewer
- Patients with the Koebner phenomenon
- People with the skin type 6
- Patients with melanoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52057
About this study
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
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.
Read the 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.
- Conditions
- Photodamaged Skin
- Being tested
- CO2-laser, Vaseline, Bepanthen
- Keywords
- photodamaged skin, wound healing, CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2-laserDevice
Patients with photo-damaged skin are treated with the CO2 laser to remove damaged skin layers.
VaselineDrug
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.
BepanthenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CO2-laser; Drug: Vaseline; Drug: Bepanthen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
TEWL is the most important parameter for the assessment of skin barrier function.
Measured: Over 2 weeks (immediately after laser treatment and on day 1, 2, 5 and 14 after laser treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Mar 2017
- Primary completion22 Jan 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Photodamaged SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens M. Baron, Prof. Dr. med., Principal investigator, RWTH Aachen University, Department of Dermatology and Allergology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095872
- Sponsor's protocol ID
- 16-011
- Acronym
- CO2
- Status last verified
- May 2018
- First submitted
- 24 Feb 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bogdan Allemann I, Kaufman J. Laser principles. Curr Probl Dermatol. 2011;42:7-23. doi: 10.1159/000328236. Epub 2011 Aug 16.
PubMed 21865794Reinholz 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.
PubMed 23647643Marquardt 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.
PubMed 25771913Wigger-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.
PubMed 19247233
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03095872
- Acronym / sponsor ID
- CO2 / 16-011
- Conditions
- Photodamaged Skin
- Keywords
- photodamaged skin, wound healing, CO2 laser
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bepanthen/Vaseline | Experimental | Device: CO2-laser, Drug: Vaseline, Drug: BepanthenOne half of the wound occuring after CO2 laser therapy of photo-damaged skin is treated with Bepanthen and the other half with Vaseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- photodamaged skin, which need to be treated with the fractional ablative CO2 laser
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2-laserPatients with photo-damaged skin are treated with the CO2 laser to remove damaged skin layers. | Device | Bepanthen/Vaseline |
| VaselineAfter 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/Vaseline |
| BepanthenAfter 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. | Drug | Bepanthen/Vaseline |
Primary outcome
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.
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.
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.
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).
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Background: PubMed 21865794Bogdan Allemann I, Kaufman J. Laser principles. Curr Probl Dermatol. 2011;42:7-23. doi: 10.1159/000328236. Epub 2011 Aug 16.
- Background: PubMed 23647643Reinholz 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.
- Background: PubMed 25771913Marquardt 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.
- Background: PubMed 19247233Wigger-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.
- Leitlinie zur Behandlung der aktinischen Keratosen C44.X der Deutschen Dermatologischen Gesellschaft.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Photodamaged Skin
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
Not yet recruitingPhase 2/3
Study Comparing Two Serums With Intense Pulsed Light for the Treatment of Moderate to Severe Photodamage and Crepiness on the Forearms
Photodamaged Skin
Not yet recruiting
A Synergistic Approach to Remodeling of Photodamaegd Skin: Exploring Laser-Assisted Biostimulator Delivery
Photodamaged Skin, Skin Cancer Prevention
Recruiting
2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles
Photodamaged Skin, Rhytids
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens M. Baron, Prof. Dr. med. principal investigator
RWTH Aachen University, Department of Dermatology and Allergology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CO2-laser, Vaseline and Bepanthen in people with Photodamaged Skin, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095872, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.