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Trial record 3 of 27 for:    Open Studies | "Hyperbaric Oxygenation"

Hyperbaric Therapy and Deep Chemical Peeling

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00425789
First received: January 22, 2007
Last updated: April 4, 2011
Last verified: December 2005
  Purpose

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


Condition Intervention Phase
Chemical Peeling
Procedure: Treatment with Hyperbaric oxygen
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperbaric Therapy and Healing From Deep Chemical Peel

Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Study Completion Date: July 2007
Detailed Description:

The study will include 40 post-deep peel women (exoderm), older than 18 years old, treated by the same dermatologist.

The treatment group will recieve 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.

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

Follow -up:

The same dermatologist will follow-up, on regular dates: the follow-up examination will start at day 1 to mask\occlusive dressing removal (equivalent to day 7 post-peel), and at days 7, 28, and after 3 months. All follow-up examinations will take place at noon (04-08 pm) regularly.

Efficacy parameters:

All patients will be asked to fill up a daily questionnaire on the first week after peel, and score the severity of pain, pruritus and tightness of facial skin (1 to 5). They will also mention the daily analgesic usage.

Parameters that will be evaluated by the dermatologist during the study will be: tightness of the skin, pain/burning, pruritus/stinging, swelling/edema, erythema, crusting, and scaling, assessed on a 4-point severity scale (0- best, 3- worst).

Photographs:

Photographs of the patients in 5 angles views will be taken on the day of peel, day of mask removal (7), day 28 and after 3 months.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients will be excluded if they have known middle ear disease, chronic lung disease or claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425789

Contacts
Contact: Tal Friedman, MD +972-574-225961 dr.tali@gmail.com
Contact: Shai Efrati, MD +972-577-346364 efratishai@013.net

Locations
Israel
Research & Development Unit, Assaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Tal Friedman, MD    +972-574-225961    dr.tali@gmail.com   
Contact: Shai Efrati, MD    +972-577-346364    efratishai@013.net   
Principal Investigator: Tal Friedman, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Tal Friedman, MD Assaf-Harofeh Medical Center
Study Director: Shai Efrati, MD Assaf-Harofeh Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00425789     History of Changes
Other Study ID Numbers: 115/05
Study First Received: January 22, 2007
Last Updated: April 4, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
Deep Chemical Peeling
Hyperbaric Therapy
post-deep peel

ClinicalTrials.gov processed this record on November 25, 2014