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| Sponsored by: |
Assaf-Harofeh Medical Center |
| Information provided by: | Assaf-Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00425789 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study |
| Official Title: | Hyperbaric Therapy and Healing From Deep Chemical Peel |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2007 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tal Friedman, MD | +972-574-225961 | dr.tali@gmail.com |
| Contact: Shai Efrati, MD | +972-577-346364 | efratishai@013.net |
| 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 | |||||
| Assaf-Harofeh Medical Center |
| Principal Investigator: | Tal Friedman, MD | Assaf-Harofeh Medical Center |
| Study Director: | Shai Efrati, MD | Assaf-Harofeh Medical Center |
More Information
| Study ID Numbers: | 115/05 |
| First Received: | January 22, 2007 |
| Last Updated: | January 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00425789 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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