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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 22, 2007 | ||||||||
| Last Updated Date | January 22, 2007 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hyperbaric Therapy and Deep Chemical Peeling | ||||||||
| Official Title ICMJE | Hyperbaric Therapy and Healing From Deep Chemical Peel | ||||||||
| 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 |
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| 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. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study | ||||||||
| Condition ICMJE | Chemical Peeling | ||||||||
| Intervention ICMJE | Procedure: Treatment with Hyperbaric oxygen | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 40 | ||||||||
| Completion Date | July 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00425789 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 115/05 | ||||||||
| Study Sponsor ICMJE | Assaf-Harofeh Medical Center | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Assaf-Harofeh Medical Center | ||||||||
| Verification Date | December 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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