NCT00425789

Brief Summary

To evaluate whether treatment with Hyperbaric oxygen can accelerate skin recovery after deep peeling, and decrease frequency and severity of local side effects and complications. 20 post peel patients will recieve 5 daily hyperbaric treatments, starting from day 7 to peel.Patient's followup will include self- filling questionnaire and photographs

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 5, 2011

Status Verified

December 1, 2005

First QC Date

January 22, 2007

Last Update Submit

April 4, 2011

Conditions

Chemical Peeling

Keywords

Deep Chemical PeelingHyperbaric Therapypost-deep peel

Interventions

Treatment with Hyperbaric oxygenPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study will include 40 post-deep peel women (exoderm), older than 18 years old, treated by the same dermatologist (dr. Landau).
  • The treatment group will receive 5 consecutive daily hyperbaric treatments, 1 hours long each, at 2 ATF, starting from day 7 to peel. Prior to treatment, each patient will be signed on informed consent and will have complete physical examination.
  • The control group will be matched by the following parameters: age, skin color and type, and indication for peeling, and will be picked up by the dermatologist.

You may not qualify if:

  • Patients will be excluded if they have known middle ear disease, chronic lung disease or claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research & Development Unit, Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Tal Friedman, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

  • Shai Efrati, MD

    Assaf-Harofeh Medical Center

    STUDY DIRECTOR

Central Study Contacts

Tal Friedman, MD

CONTACT

+972-574-225961dr.tali@gmail.com

Shai Efrati, MD

CONTACT

+972-577-346364efratishai@013.net

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

January 1, 2007

Study Completion

July 1, 2007

Last Updated

April 5, 2011

Record last verified: 2005-12

Locations

IL(1)