Hyperbaric Therapy and Deep Chemical Peeling

Chemical Peeling Clinical Trial

Official title:

Hyperbaric Therapy and Healing From Deep Chemical Peel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00425789
• Other study ID #: 115/05
• Status: Recruiting
• Phase: Phase 1
• First received: January 22, 2007
• Last updated: April 4, 2011
• Start date: January 2007
• Est. completion date: July 2007

Study information

• Verified date: December 2005
• Source: Assaf-Harofeh Medical Center
• Contact: Tal Friedman, MD
• Phone: +972-574-225961
• Email: dr.tali[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemical Peeling

Intervention

Procedure:
• Treatment with Hyperbaric oxygen

Locations

Country	Name	City	State
Israel	Research & Development Unit, Assaf-Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel,