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Histological Skin Changes of Different Peeling Agents in Surgically Subcutaneous Undermined Skin

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ClinicalTrials.gov Identifier: NCT02848209
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
Ocean Clinic Marbella, Spain
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.

Condition or disease Intervention/treatment Phase
Burn of Face, Head and/or Neck Peeling Procedure: TCA 20% Peeling Procedure: Phenol/croton oil Peeling Procedure: TCA 40% Peeling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Histological Evaluation of Peeling Induced Skin Changes of Different Peeling Agents in Surgically Subcutaneous Undermined Skin Flaps in Facelift Patients
Study Start Date : July 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
No Intervention: Control
No peeling applied on the skin flap
Experimental: Drug: TCA 20% Peeling
Trichloroacetic acid 20% applied on the skin flap until even frosting for 2-4 minutes.
Procedure: TCA 20% Peeling
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.

Experimental: Drug: TCA 40% Peeling
Trichloroacetic acid 40% applied on the skin flap until even frosting for 2-4 minutes.
Procedure: TCA 40% Peeling
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.

Experimental: Drug: Phenol/croton oil Peeling
Phenol/croton oil applied on the skin flap occluded with silicone tape for 24 hours and not neutralized.
Procedure: Phenol/croton oil Peeling
Phenol/croton oil is applied on subcutaneous undermined skin samples and occluded with silicone tape for 24 hours and not neutralized.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Chemical burn grade [ Time Frame: 24 hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT02848209


Locations
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Spain
Ocean Clinic
Marbella, Malaga, Spain, 29600
Sponsors and Collaborators
University Hospital Tuebingen
Ocean Clinic Marbella, Spain
Investigators
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Principal Investigator: Phillipp Gonser, MD BG Trauma Centre Tuebingen

Additional Information:
Publications of Results:
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02848209     History of Changes
Other Study ID Numbers: PEEL1
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Tuebingen:
Peeling
Histological skin changes
Trichloroacetic acid peel
phenol/croton oil peel
Additional relevant MeSH terms:
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Phenol
Croton Oil
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions
Pharmaceutical Solutions
Dermatologic Agents