Burn of Face, Head and/or NeckNCT02848209
Histological Skin Changes of Different Peeling Agents in Surgically Subcutaneous Undermined Skin
A study testing TCA 20% Peeling, Phenol/croton oil Peeling and TCA 40% Peeling in people with Burn of Face, Head and/or Neck and Peeling, run by University Hospital Tuebingen at 1 site in Spain.
Trial summary
The purpose of this study is to examine the histological skin changes induced by different peeling agents (Trichloroacetic acid 25% and 40% and phenol/croton oil) in subcutaneous undermined facial skin flaps. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Burn of Face, Head and/or Neck, Peeling
- What is being tested?
- TCA 20% Peeling, Phenol/croton oil Peeling and TCA 40% Peeling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Nov 2016
- Phase
- Interventional
- 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 40 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The population consists of all female English-speaking Caucasian patients of the Department for plastic and aesthetic surgery of Ocean Clinic Marbella, Spain, between 40 and 80 years seeking for elective facial rejuvenation with the PAVE-lift technique (peeling assisted volume enhancing Facelift) who give formal written informed consent to take part in the study.
Who cannot join
- any known cardiac problems like arrhythmia or conduction disorders, such as Wolff Parkinson White Syndrome
- previous facelift surgery
- previous facial peeling
- Fitzpatrick skin type 4, 5 and 6 (dark tanned skin types in which the applied peeling agents are known to lead to unpleasant results such as hypopigmentation and skin lightening)
- any former episode of skin cancer
- any inability to give informed written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Evaluation of Peeling Induced Skin Changes of Different Peeling Agents in Surgically Subcutaneous Undermined Skin Flaps in Facelift Patients
The purpose of this study is to examine the histological skin changes induced by different peeling agents (Trichloroacetic acid 25% and 40% and phenol/croton oil) in subcutaneous undermined facial skin flaps.
Read the detailed description
Written informed consent has to be obtained from 9 random female Caucasian patients aged between 40 and 80 years who will receive a Peeling assisted volume enhancing (PAVE) facelift procedure in Ocean Clinic, Marbella Spain, to take part in the histologic case control study with a within-subjects design.
After completing the facelift, the subcutaneous undermined abundant pre-auricular skin of both sides which is to be resected as consequence of the lift anyhow of each study patient is not resected and split completely in half to yield four samples of the same size, two on each side, without contacting each other in order to prevent any interaction between the peeling agents (n=9 samples per treatment). One sample serves as the control, while the other three samples are each treated with different peeling agents by the same surgeon: Trichloroacetic acid (TCA) peel at concentrations of 20% and 40% and a phenol/croton oil peel. The TCA samples are peeled immediately for 2 to 4 minutes until even frosting and neutralized at the even frosting point. The phenol/croton oil peeled samples are occluded with silicone tape for 24 hours and not neutralized. After 24 hours during the routine in-hospital stay of the patient, the skin samples are resected, the preauricular wound is closed, and all samples are placed in 10 % neutral buffered formalin. The samples are immediately processed, trimmed, embedded, sectioned and stained with haematoxylin and eosin (H\&E) by the same researcher. Histological evaluation which will take place in Tuebingen is carried out using a microscope, and pictures are captured at 10x, 25x and 100x magnification using a digital camera. Two trained histological examiners blinded to the study design independently perform histological evaluations. The depth of necrosis in µm is determined by analysing the tissue damage in relation to histological skin layers. All slices are evaluated using light microscopy to assess the mean depth of necrosis in three samples at three different sites for each specimen. The vertical height in µm between the cutaneous basal membrane and the deepest penetration of tissue damage is measured as well as the total thickness of the epidermis and dermis. Based on the histomorphological changes, actual peeling depth is determined and classified analogously to the current classification of burns: superficial, superficial-partial, deep-partial and full thickness.
- Conditions
- Burn of Face, Head and/or Neck, Peeling
- Being tested
- TCA 20% Peeling, Phenol/croton oil Peeling, TCA 40% Peeling
- Keywords
- Peeling, Histological skin changes, Trichloroacetic acid peel, phenol/croton oil peel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCA 20% PeelingProcedure or surgery
TCA peel at a concentration of 20% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point.
Phenol/croton oil PeelingProcedure or surgery
Phenol/croton oil is applied on subcutaneous undermined skin samples and occluded with silicone tape for 24 hours and not neutralized.
TCA 40% PeelingProcedure or surgery
TCA peel at a concentration of 40% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No peeling applied on the skin flap |
| Drug: TCA 20% Peeling | Experimental | Trichloroacetic acid 20% applied on the skin flap until even frosting for 2-4 minutes. Receives: Procedure: TCA 20% Peeling |
| Drug: TCA 40% Peeling | Experimental | Trichloroacetic acid 40% applied on the skin flap until even frosting for 2-4 minutes. Receives: Procedure: TCA 40% Peeling |
| Drug: Phenol/croton oil Peeling | Experimental | Phenol/croton oil applied on the skin flap occluded with silicone tape for 24 hours and not neutralized. Receives: Procedure: Phenol/croton oil Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peeling depth
The vertical height in µm between the cutaneous basal membrane and the deepest penetration of tissue damage is measured as well as the total thickness of the epidermis and dermis
Measured: 24 hours
Secondary outcomes (1)
Chemical burn grade
Based on the histomorphological changes, actual peeling depth is determined and classified analogously to the current classification of burns: superficial, superficial-partial, deep-partial and full thickness.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn of Face, Head and/or NeckStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Clinic
- Responsible party
- Sponsor
- Investigators
- Phillipp Gonser, MD, Principal investigator, BG Trauma Centre Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848209
- Sponsor's protocol ID
- PEEL1
- Status last verified
- Jul 2016
- First submitted
- 25 Jul 2016
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaye KO, Schaller HE, Jaminet P, Gonser P. The PAVE (peeling-assisted volume-enhancing) lift: A retrospective 6-year clinical analysis of a combined approach for facial rejuvenation. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):1128-33. doi: 10.1016/j.bjps.2016.04.012. Epub 2016 May 4.
PubMed 27320171
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Evaluation of Peeling Induced Skin Changes of Different Peeling Agents in Surgically Subcutaneous Undermined Skin Flaps in Facelift Patients
- ClinicalTrials.gov ID
- NCT02848209
- Acronym / sponsor ID
- PEEL1
- Conditions
- Burn of Face, Head and/or Neck, Peeling
- Keywords
- Peeling, Histological skin changes, Trichloroacetic acid peel, phenol/croton oil peel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Ocean Clinic
- Study start
- Jul 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
The purpose of this study is to examine the histological skin changes induced by different peeling agents (Trichloroacetic acid 25% and 40% and phenol/croton oil) in subcutaneous undermined facial skin flaps.
Detailed description
Written informed consent has to be obtained from 9 random female Caucasian patients aged between 40 and 80 years who will receive a Peeling assisted volume enhancing (PAVE) facelift procedure in Ocean Clinic, Marbella Spain, to take part in the histologic case control study with a within-subjects design.
After completing the facelift, the subcutaneous undermined abundant pre-auricular skin of both sides which is to be resected as consequence of the lift anyhow of each study patient is not resected and split completely in half to yield four samples of the same size, two on each side, without contacting each other in order to prevent any interaction between the peeling agents (n=9 samples per treatment). One sample serves as the control, while the other three samples are each treated with different peeling agents by the same surgeon: Trichloroacetic acid (TCA) peel at concentrations of 20% and 40% and a phenol/croton oil peel. The TCA samples are peeled immediately for 2 to 4 minutes until even frosting and neutralized at the even frosting point. The phenol/croton oil peeled samples are occluded with silicone tape for 24 hours and not neutralized. After 24 hours during the routine in-hospital stay of the patient, the skin samples are resected, the preauricular wound is closed, and all samples are placed in 10 % neutral buffered formalin. The samples are immediately processed, trimmed, embedded, sectioned and stained with haematoxylin and eosin (H\&E) by the same researcher. Histological evaluation which will take place in Tuebingen is carried out using a microscope, and pictures are captured at 10x, 25x and 100x magnification using a digital camera. Two trained histological examiners blinded to the study design independently perform histological evaluations. The depth of necrosis in µm is determined by analysing the tissue damage in relation to histological skin layers. All slices are evaluated using light microscopy to assess the mean depth of necrosis in three samples at three different sites for each specimen. The vertical height in µm between the cutaneous basal membrane and the deepest penetration of tissue damage is measured as well as the total thickness of the epidermis and dermis. Based on the histomorphological changes, actual peeling depth is determined and classified analogously to the current classification of burns: superficial, superficial-partial, deep-partial and full thickness.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No peeling applied on the skin flap |
| Drug: TCA 20% Peeling | Experimental | Procedure: TCA 20% PeelingTrichloroacetic acid 20% applied on the skin flap until even frosting for 2-4 minutes. |
| Drug: TCA 40% Peeling | Experimental | Procedure: TCA 40% PeelingTrichloroacetic acid 40% applied on the skin flap until even frosting for 2-4 minutes. |
| Drug: Phenol/croton oil Peeling | Experimental | Procedure: Phenol/croton oil PeelingPhenol/croton oil applied on the skin flap occluded with silicone tape for 24 hours and not neutralized. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The population consists of all female English-speaking Caucasian patients of the Department for plastic and aesthetic surgery of Ocean Clinic Marbella, Spain, between 40 and 80 years seeking for elective facial rejuvenation with the PAVE-lift technique (peeling assisted volume enhancing Facelift) who give formal written informed consent to take part in the study.
Key exclusion criteria (6 listed)
- any known cardiac problems like arrhythmia or conduction disorders, such as Wolff Parkinson White Syndrome
- previous facelift surgery
- previous facial peeling
- Fitzpatrick skin type 4, 5 and 6 (dark tanned skin types in which the applied peeling agents are known to lead to unpleasant results such as hypopigmentation and skin lightening)
- any former episode of skin cancer
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 |
|---|---|---|
| TCA 20% PeelingTCA peel at a concentration of 20% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point. | Procedure or surgery | Drug: TCA 20% Peeling |
| Phenol/croton oil PeelingPhenol/croton oil is applied on subcutaneous undermined skin samples and occluded with silicone tape for 24 hours and not neutralized. | Procedure or surgery | Drug: Phenol/croton oil Peeling |
| TCA 40% PeelingTCA peel at a concentration of 40% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point. | Procedure or surgery | Drug: TCA 40% Peeling |
Primary outcome
Peeling depth
Time frame: 24 hours
The vertical height in µm between the cutaneous basal membrane and the deepest penetration of tissue damage is measured as well as the total thickness of the epidermis and dermis
1 secondary outcome
Chemical burn grade
Time frame: 24 hours
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 20 Mar 2017.
- Results publication: PubMed 27320171Kaye KO, Schaller HE, Jaminet P, Gonser P. The PAVE (peeling-assisted volume-enhancing) lift: A retrospective 6-year clinical analysis of a combined approach for facial rejuvenation. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):1128-33. doi: 10.1016/j.bjps.2016.04.012. Epub 2016 May 4.
- Homepage of the recruiting and treating clinicLink provided by the sponsor.
- Homepage of the evaluating clinicLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Phillipp Gonser, MD principal investigator
BG Trauma Centre Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCA 20% Peeling, Phenol/croton oil Peeling and TCA 40% Peeling in people with Burn of Face, Head and/or Neck and Peeling, run by University Hospital Tuebingen at 1 site in Spain.
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 1 inclusion and 6 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 20 Mar 2017. 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 Spain. 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.
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?
Peeling depth (time frame: 24 hours). 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 NCT02848209, which also lists 1 linked publication.
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 20 Mar 2017.