NCT02848209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 20, 2017

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

July 25, 2016

Last Update Submit

March 16, 2017

Conditions

Burn of Face, Head and/or NeckPeeling

Keywords

PeelingHistological skin changesTrichloroacetic acid peelphenol/croton oil peel

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Secondary Outcomes (1)

  • Chemical burn grade

    24 hours

Study Arms (4)

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.

Procedure: TCA 20% Peeling

Drug: TCA 40% Peeling

EXPERIMENTAL

Trichloroacetic acid 40% applied on the skin flap until even frosting for 2-4 minutes.

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.

Procedure: Phenol/croton oil Peeling

Interventions

TCA 20% PeelingPROCEDURE

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.

Drug: TCA 20% Peeling
Phenol/croton oil PeelingPROCEDURE

Phenol/croton oil is applied on subcutaneous undermined skin samples and occluded with silicone tape for 24 hours and not neutralized.

Drug: Phenol/croton oil Peeling
TCA 40% PeelingPROCEDURE

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.

Drug: TCA 40% Peeling

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ocean Clinic

Marbella, Malaga, 29600, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27320171RESULT

Related Links

MeSH Terms

Interventions

Tooth ExfoliationPhenol

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Phillipp Gonser, MD

    BG Trauma Centre Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 28, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 20, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)